[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a TRACE section on purpose and scope of the traceability matrix for VisitorPass Access Management, a Class A Visitor Management System. Reference IEC 62304 Clause 5.7.1.
Kiosk application for visitor registration and badge printing in hospital lobbies. Administrative access control.

[Assistant] Content: Traceability for the VisitorPass Access Management per Clause 5.7.1 links system requirements to software requirements, software requirements to design elements, and design elements to verification test cases. The matrix serves as the primary evidence that the Visitor Management System verification is complete and that no requirement is unaddressed.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SDP section on problem reporting and investigation for WaveReview EEG Archive Viewer, a Class A EEG Archive Viewer. Reference IEC 62304 Clauses 9.1, 9.2.
Desktop application for reviewing archived EEG recordings. Playback and waveform display only, no seizure detection.

[Assistant] Content: Problems identified in the WaveReview EEG Archive Viewer are reported per Clause 9.1 with anomaly description, affected component, severity, and reproduction steps. Investigation per Clause 9.2 determines root cause and impact. Relevant parties are advised per Clause 9.3 when the problem affects the EEG Archive Viewer safety or regulatory compliance.


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on lightweight review process for Class A for CalibrationTracker Equipment Logger, a Class A Calibration Record System. Reference IEC 62304 Clause 5.1.1.
Web application tracking calibration dates and results for medical test equipment. Administrative record keeping.

[Assistant] Content: The CalibrationTracker Equipment Logger review process is proportionate to the Class A risk level. The project lead reviews each deliverable for technical accuracy, and the quality representative verifies compliance with SOPs. Reviews are documented but do not require independent technical review of the Calibration Record System verification activities.


[System] You are an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-FUNC-001: "measurement data archival" (Category: functional)
Project: GlucoEdge Continuous Glucose Platform | Hybrid CGM Edge-Cloud Platform | Class B
Continuous glucose monitoring with edge processing on wearable and cloud-based trend analysis for clinician review. Hybrid system: embedded BLE firmware on a wearable CGM patch streams readings to a phone app, which uploads to cloud for trend analysis and physician dashboard.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: The GlucoEdge Continuous Glucose Platform shall log measurement data with timestamps to non-volatile storage and provide a mechanism to retrieve logged data via BLE 5.0 to phone.
Rationale: Persistent measurement records enable post-hoc analysis and meet regulatory requirements for data retention.
Priority: Desirable
Acceptance Criterion: Logged data is retrievable after power cycle, with all timestamps accurate to within 1 second of the reference clock.
Source: User need


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the PillRemind (medication reminder app, Class A):

"The PillRemind development follows IEC 62304-4 for the software lifecycle."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304-4" which is incorrect. IEC 62304 has no Part 4. All references must be corrected.


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on configuration identification approach for DermaAssist Skin Lesion Classifier, a Class B Skin Lesion Classification App. Reference IEC 62304 Clauses 8.1, 8.1.1.
Mobile app using a CNN to classify skin lesion images as benign/suspicious. Decision support requiring dermatologist confirmation.

[Assistant] Content: All artifacts produced during DermaAssist Skin Lesion Classifier development are placed under configuration control per Clause 8.1. Configuration items include source files, build definitions, documentation, test scripts, and SOUP component packages. Each item is uniquely identified by a repository path and immutable revision hash.


[System] You are an IEC 62304 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

[User]
Review this documentation excerpt for the RetinaScan Pro (diabetic retinopathy screening AI, Class B):

"This plan references the following normative standards: IEC 62304:2006+AMD1:2015, ISO 14971:2019, ISO 13485:2016, and IEC 62366-1:2015+AMD1:2020. Each standard is cited with its correct edition year. The RetinaScan Pro development complies with all applicable clauses for Class B."

[Assistant]
Verdict: PASS
Note: Content correctly specifies Class B requirements; uses the correct IEC 62304 citation; correctly references ISO 14971:2019. Standards references are accurate.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SRS section on user interaction requirements for LinacControl Beam Delivery System, a Class C Linear Accelerator Control Software. Reference IEC 62304 Clause 5.2.2.
Software controlling linear accelerator beam delivery during radiation therapy. Beam-on errors could deliver lethal radiation doses.

[Assistant] Content: Interaction requirements for the LinacControl Beam Delivery System specify all user-facing behaviors of the Linear Accelerator Control Software: screen layouts, navigation flows, alarm presentation (if applicable), and error messaging. Each interaction requirement includes the trigger condition, the expected system response, and the acceptance criteria for verification.


[System] You are a requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-FUNC-004: "display update rate for Dosimetry Data Logger" (Category: functional)
Project: DoseLog Radiation Badge Reader | Dosimetry Data Logger | Class A
Reading and archiving personal radiation exposure data from dosimeter badges. Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: The DoseLog Radiation Badge Reader display shall present current readings on USB within the specified maximum update latency.
Rationale: Timely display updates ensure the user observes current readings without perceiving lag.
Priority: Mandatory
Acceptance Criterion: Measured display update interval is within 10% of the specified refresh period across 100 consecutive update cycles.
Source: User need


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on requirements verification approach for InhaleSense Smart Inhaler Tracker, a Class A Smart Inhaler Adherence Tracker. Reference IEC 62304 Clause 5.2.6.
Firmware for a smart inhaler attachment detecting actuation events, tracking medication adherence, and syncing data to a mobile app and clinician portal.

[Assistant] Content: The InhaleSense Smart Inhaler Tracker requirements verification checklist per Clause 5.2.6 confirms: no ambiguous requirements, no untestable requirements, no contradictions between requirements, and complete traceability to system requirements and risk controls. The review is documented with reviewer names, findings, and disposition.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SDP section on Class C classification justification and implications for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clause 4.3.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: Safety classification analysis concluded that the CochleaMap CI Fitting Software is Class C under Clause 4.3. The Cochlear Implant Fitting Software processes electrode impedance measurement and software failure during Programming electrode mapping and stimulation parameters for cochlear implant sound processors could cause serious harm. This is the highest-rigor classification in IEC 62304, requiring comprehensive documentation, unit testing with quantitative coverage targets, integration testing, system testing, and independent review of all verification outputs.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the CaloriePal (nutrition tracking app, Class A):

"The CaloriePal employs Test-Driven Development with unit tests written before implementation."

[Assistant]
Verdict: FAIL
Note: Content mandates unit testing for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Unit verification (Clause 5.5) is not required for Class A.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SRS section on latency and throughput requirements for DoseLog Radiation Badge Reader, a Class A Dosimetry Data Logger. Reference IEC 62304 Clause 5.2.2.
Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

[Assistant] Content: The DoseLog Radiation Badge Reader shall meet defined latency bounds for all safety-relevant processing paths. Throughput requirements specify the data rates the Dosimetry Data Logger must sustain from dosimeter badge reader without data loss or processing backlog on Windows desktop.


[System] You are an IEC 62304 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

[User]
Review this documentation excerpt for the PhysioTrack Rehab (rehabilitation tracking system, Class B):

"IEC 62304 Clause 5.3.7 requires the PhysioTrack Rehab to implement operational qualification."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.3.7 which does not exist. Clause 5.3 has 5.3.1 through 5.3.6 only. The reference must be corrected to a valid clause number.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SDP section on development methodology for Class A for PharmLog Medication History Viewer, a Class A Medication History Viewer. Reference IEC 62304 Clause 5.1.1.
Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

[Assistant] Content: An iterative development approach with defined phase gates is adopted for the PharmLog Medication History Viewer, appropriate for the Class A classification where system-level verification is the primary quality gate. Each iteration produces a testable increment of the Medication History Viewer functionality, with reviews at Requirements Complete, Implementation Complete, and Release Readiness milestones.


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SRS section on purpose of the SRS document for IncidentReport Clinical Event Logger, a Class A Incident Reporting System. Reference IEC 62304 Clause 5.2.1.
Web form for staff to submit clinical incident reports. Data entry and routing only, no analysis.

[Assistant] Content: The purpose of this SRS is to establish the complete set of software requirements for the IncidentReport Clinical Event Logger, providing the basis for design, implementation, and verification of the Incident Reporting System. Requirements are organized by type and traced to their originating system requirement, risk control measure, or stakeholder need per Clause 5.2.1.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a TRACE section on purpose and scope of the traceability matrix for InfuRate IV Flow Calculator, a Class B Infusion Rate Calculator. Reference IEC 62304 Clause 5.7.1.
Desktop calculator for IV infusion rates based on drug concentration, patient weight, and ordered dose. Clinical decision support tool.

[Assistant] Content: The InfuRate IV Flow Calculator traceability matrix provides end-to-end requirement coverage evidence per Clause 5.7.1. Every SRS requirement for the Infusion Rate Calculator is traced to its implementing software item and to the verification test case(s) confirming correct implementation. Orphaned requirements and untested implementations are flagged for resolution.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the HydroLog (hydration tracking wellness app, Class A):

"The HydroLog conforms to IEC 62304:2006+AMD1:2015. Safety classification per Clause 4.3 designates this hydration tracking wellness app as Class A. Risk management follows ISO 14971:2019 with guidance from ISO/TR 24971:2020."

[Assistant]
Verdict: PASS
Note: Content correctly limits Class A to system-level verification; uses the correct IEC 62304 citation; correctly references ISO 14971:2019. Standards references are accurate.


[System] You are an IEC 62304 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

[User]
Review this documentation excerpt for the ChemoCalc (chemotherapy dose calculator, Class C):

"System testing for the ChemoCalc establishes tests per Clause 5.7.1. The software problem resolution process is used per Clause 5.7.2. Retesting after changes follows Clause 5.7.3. Test records conform to Clause 5.7.5."

[Assistant]
Verdict: PASS
Note: Content limits verification to system testing per Clause 5.7. Standards references are accurate.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SRS section on requirements conventions and identification scheme for BreathSync ICU Ventilator Controller, a Class C ICU Ventilator Controller Software. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Software controlling an ICU mechanical ventilator with multiple ventilation modes (volume, pressure, SIMV). Failure could result in patient death.

[Assistant] Content: Each requirement for the BreathSync ICU Ventilator Controller is assigned a unique identifier and tagged with its type (functional, performance, interface, or safety) per Clause 5.2.2. Requirements are written in "shall" statements that are individually testable. The requirement set is baselined and controlled under the change management process.


[System] You are an IEC 62304 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

[User]
Review this documentation excerpt for the SleepWell (sleep quality display app, Class A):

"The SleepWell development process requires detailed design documentation for every software unit, with unit tests verifying each design element."

[Assistant]
Verdict: FAIL
Note: Content mandates detailed design and unit testing for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Detailed design (Clause 5.4) and unit verification (Clause 5.5) are not required for Class A.


[System] You are an IEC 62304 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

[User]
Review this documentation excerpt for the EchoAssist (echocardiogram analysis aid, Class B):

"Software release for the EchoAssist follows Clause 5.8. Completeness is ensured per Clause 5.8.1, version identification per Clause 5.8.2, and known residual anomalies are documented per Clause 5.8.4 and evaluated per Clause 5.8.5."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the EchoAssist (echocardiogram analysis aid, Class B). Standards references are accurate.


[System] You are an IEC 62304 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

[User]
Review this documentation excerpt for the RetinaScan Pro (diabetic retinopathy screening AI, Class B):

"REQ-SRS-034: The RetinaScan Pro shall complete self-test diagnostics within 5 seconds of power-on and report any detected hardware faults. Acceptance criterion: inject simulated hardware faults and verify detection within the time limit. Priority: Mandatory. Source: System requirement."

[Assistant]
Verdict: PASS
Note: Content requirement is properly structured with measurable acceptance criteria. Standards references are accurate.


[System] You are an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-SEC-001: "user identity verification" (Category: security)
Project: RetinaScan Diabetic Retinopathy Screener | Retinal Screening Software | Class B
AI-assisted screening of retinal images for diabetic retinopathy signs, requiring specialist confirmation. Desktop software analyzing retinal fundus images to detect signs of diabetic retinopathy for ophthalmologist review.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: Access to configuration and administrative functions of the Retinal Screening Software shall be restricted to authenticated and authorized users.
Rationale: Unauthorized configuration changes to the Retinal Screening Software could compromise its intended function or patient safety.
Priority: Mandatory
Acceptance Criterion: Configuration modification is rejected when attempted without valid credentials, verified across all configurable parameters.
Source: Risk control


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a TRACE section on purpose and scope of the traceability matrix for ThermoWatch Core Temperature Monitor, a Class B Core Temperature Monitor Firmware. Reference IEC 62304 Clause 5.7.1.
Continuous core temperature monitoring firmware using an ingestible sensor pill. Displays temperature trend with configurable alerts.

[Assistant] Content: The purpose of this traceability matrix is to confirm complete coverage of the ThermoWatch Core Temperature Monitor software requirements through design and verification per Clause 5.7.1. Bidirectional tracing enables identification of gaps (unimplemented requirements) and orphans (implementations without requirements) in the Core Temperature Monitor Firmware.


[System] You are an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-SEC-001: "patient data protection" (Category: security)
Project: HemaCount Digital Cell Counter | IVD Digital Cell Counter Software | Class B
Automated white blood cell differential counting from digitized peripheral blood smear images. Desktop software performing automated differential white blood cell counting on digitized blood smear images using computer vision.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: Patient-identifiable data stored by the HemaCount Digital Cell Counter shall be encrypted at rest using a validated cryptographic algorithm with a key length of at least 256 bits.
Rationale: Data-at-rest encryption is required to meet privacy regulations and protect patient confidentiality.
Priority: Mandatory
Acceptance Criterion: Cryptographic implementation validated against NIST standards with no known vulnerabilities in the selected algorithm.
Source: Regulatory


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SRS section on purpose of the SRS document for AutoHUD Heads-Up Display Controller, a Class A Automotive HUD Controller Firmware. Reference IEC 62304 Clause 5.2.1.
Firmware rendering vehicle speed, navigation, and ADAS warnings on a windshield-projected heads-up display.

[Assistant] Content: This Software Requirements Specification defines the functional, performance, and interface requirements for the AutoHUD Heads-Up Display Controller Automotive HUD Controller Firmware. Requirements are derived from system requirements, the risk management file, and stakeholder needs analysis per IEC 62304 Clause 5.2.1. Each requirement is uniquely identified, prioritized, and traceable to its source.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SDP section on acceptance criteria and independent review for Class C for BrachyDose HDR Afterloader Controller, a Class C HDR Brachytherapy Afterloader Firmware. Reference IEC 62304 Clauses 5.5.3, 5.5.5, 5.7.4.
Firmware controlling high-dose-rate brachytherapy source positioning and dwell times. Source positioning errors cause lethal local radiation.

[Assistant] Content: Acceptance of the BrachyDose HDR Afterloader Controller at Class C requires documented evidence at all three verification levels. Unit verification records must include coverage metrics meeting the targets defined in this plan. System test completeness per Clause 5.7.4 must show that every SRS requirement is covered. An independent reviewer signs off on each verification deliverable for the HDR Brachytherapy Afterloader Firmware.


[System] You are an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-DATA-001: "measurement data lifecycle" (Category: data)
Project: AquaGuard Water Quality Monitor | Water Quality Monitoring Firmware | Class A
In-situ measurement of water quality parameters for environmental monitoring. Firmware for a multi-parameter water quality probe measuring pH, dissolved oxygen, conductivity, and turbidity in rivers and lakes.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: Measurement records stored by the Water Quality Monitoring Firmware shall be maintained for the configured retention period before eligible for overwrite.
Rationale: Regulatory compliance requires that measurement records be available for the specified retention period.
Priority: Mandatory
Acceptance Criterion: Retention period validation: records created at time T are still accessible at T + retention period.
Source: Regulatory


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the PhysioTrack Rehab (rehabilitation tracking system, Class B):

"For the PhysioTrack Rehab, ISO 14971:2019 risk management is integrated with the IEC 62304 software lifecycle. Risk control measures identified in the risk analysis are incorporated as software requirements per Clause 5.2.3. The medical device risk analysis is re-evaluated per Clause 5.2.4 after requirements changes."

[Assistant]
Verdict: PASS
Note: Content correctly references ISO 14971:2019; risk management content follows ISO 14971 framework. Standards references are accurate.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SRS section on requirements conventions and identification scheme for PulseRing Smart Ring Monitor, a Class B Wearable Smart Ring Firmware + Companion App. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Wearable smart ring firmware measuring continuous PPG for heart rate and SpO2 with BLE streaming to companion mobile app for trend display.

[Assistant] Content: Each requirement for the PulseRing Smart Ring Monitor is assigned a unique identifier and tagged with its type (functional, performance, interface, or safety) per Clause 5.2.2. Requirements are written in "shall" statements that are individually testable. The requirement set is baselined and controlled under the change management process.


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on safety classification process and documentation for MedRef Clinical Reference App, a Class A Clinical Drug Reference App. Reference IEC 62304 Clause 4.3.
Standalone mobile app providing searchable drug reference database with interaction checker. Display-only — no prescription or dosing decisions.

[Assistant] Content: The safety classification of the MedRef Clinical Reference App was determined per IEC 62304 Clause 4.3, considering the software's contribution to hazardous situations identified in the ISO 14971 risk analysis. The classification is documented in the risk management file and reviewed whenever the intended use, system architecture, or risk profile of the Clinical Drug Reference App changes.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the PacePilot (pacemaker programmer, Class C):

"Maintenance activities follow IEC 62304:2020 Clause 6."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304:2020" which is incorrect. No 2020 edition exists. Current: IEC 62304:2006+AMD1:2015. All references must be corrected.


[System] You are an IEC 62304 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

[User]
Review this documentation excerpt for the InfuSafe Controller (insulin infusion pump controller, Class C):

"The InfuSafe Controller architecture is defined. The InfuSafe Controller architecture is documented. The InfuSafe Controller architecture is verified. The InfuSafe Controller architecture is reviewed. The InfuSafe Controller architecture is approved."

[Assistant]
Verdict: FAIL
Note: The documentation section exhibits repeated project name. The project name 'InfuSafe Controller' appears excessively. Sentences repeat the same assertion about the insulin infusion pump controller in different words. Content should be consolidated and each sentence should contribute unique, specific information about the InfuSafe Controller.


[System] You are an IEC 62304 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

[User]
Review this documentation excerpt for the NurseCall Hub (patient call system dashboard, Class A):

"Comprehensive unit tests shall be developed for every software module of the NurseCall Hub."

[Assistant]
Verdict: FAIL
Note: Content mandates unit testing for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Unit verification (Clause 5.5) is not required for Class A.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SAD section on SOUP component integration and requirements for BeamPlan Radiation Treatment Planner, a Class C Radiation Treatment Planning Software. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Desktop software calculating radiation treatment plans including beam angles, dose distribution, and organ-at-risk constraints.

[Assistant] Content: SOUP components in the BeamPlan Radiation Treatment Planner are integrated through defined interfaces per Clause 5.3.3. For each component, the architecture specifies the functions used, the performance expectations, and the Linux workstation with GPU requirements per Clause 5.3.4. SOUP anomaly evaluation per Clause 7.1.3 is documented in the risk management file.


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on acceptance criteria and independent review for Class C for AIDose Chemotherapy Decision Support, a Class C Cloud AI Chemotherapy Dosing SaMD. Reference IEC 62304 Clauses 5.5.3, 5.5.5, 5.7.4.
Cloud SaMD providing AI-driven chemotherapy dosing recommendations based on patient genomics, lab values, and treatment response data.

[Assistant] Content: The AIDose Chemotherapy Decision Support verification acceptance workflow proceeds bottom-up: unit tests are reviewed first (Clause 5.5.5), followed by integration tests (Clause 5.6.5), and finally system tests (Clause 5.7.4). At each level, an independent reviewer confirms pass/fail results, coverage metrics, and anomaly dispositions. No release of the Cloud AI Chemotherapy Dosing SaMD occurs until all levels are signed off.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a TRACE section on risk control coverage verification for FleetTrack GPS Tracking Module, a Class A Fleet GPS Tracking Firmware. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

[Assistant] Content: The FleetTrack GPS Tracking Module gap analysis per Clause 5.7.4 and Clause 7.3.2 verifies that the risk control traceability chain is complete. Every hazard in the risk management file that has a software control must trace to a verified requirement in the Fleet GPS Tracking Firmware. Incomplete chains are flagged and resolved before release.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the DermaScan AI (skin lesion classifier, Class B):

"Software release criteria for the DermaScan AI include completeness of all Class B deliverables (Clause 5.8.1), correct version identification (Clause 5.8.2), documented residual anomalies (Clause 5.8.4), and release approval by the quality representative."

[Assistant]
Verdict: PASS
Note: Content correctly specifies Class B requirements. Standards references are accurate.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SDP section on requirements elicitation and documentation for PowerTrack UPS Monitor, a Class A UPS Monitoring Software. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

[Assistant] Content: Elicitation of requirements for the PowerTrack UPS Monitor follows Clause 5.2.1, drawing on system requirements, stakeholder interviews, and the risk management file. Requirements are documented with unique identifiers and classified by type: functional, performance, interface, or safety for the UPS Monitoring Software.


[System] You are an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-INTF-002: "external system data exchange" (Category: interface)
Project: HomeVent BiPAP Controller | BiPAP Device Firmware | Class C
Home bilevel ventilatory support with auto-titrating pressure and leak compensation. Home bilevel positive airway pressure device firmware. Manages inspiratory/expiratory pressure, leak compensation, and patient triggering.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: The BiPAP Device Firmware shall support bidirectional data exchange with external systems over blower motor PWM.
Rationale: Interoperability enables integration of BiPAP Device Firmware data into the clinical workflow and patient record.
Priority: Desirable
Acceptance Criterion: Format validation passes for all message types with correct field encoding verified.
Source: User need


[System] You are a requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-PERF-001: "RAM and storage constraints" (Category: performance)
Project: AutoHUD Heads-Up Display Controller | Automotive HUD Controller Firmware | Class A
Rendering critical driving information on a windshield heads-up display. Firmware rendering vehicle speed, navigation, and ADAS warnings on a windshield-projected heads-up display.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: The AutoHUD Heads-Up Display Controller shall operate within the specified RAM and flash memory budget on the Qualcomm SA8155P platform, including all runtime allocations.
Rationale: Exceeding memory limits could cause undefined behavior in the Automotive HUD Controller Firmware, potentially affecting safety.
Priority: Mandatory
Acceptance Criterion: Peak RAM usage during worst-case scenario does not exceed the specified limit, with minimum margin remaining.
Source: System requirement


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on Class A classification justification and implications for ClinTrial EDC Platform, a Class A Clinical Trial EDC Web Platform. Reference IEC 62304 Clause 4.3.
Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

[Assistant] Content: The ClinTrial EDC Platform Clinical Trial EDC Web Platform receives a Class A safety classification because its failure modes result exclusively in loss of non-critical functionality. The software performs Electronic capture and management of clinical trial data across multiple investigator sites without affecting clinical decisions, therapeutic delivery, or patient monitoring that requires fail-safe behavior. This classification means detailed design (Clause 5.4), unit verification (Clause 5.5), and integration testing (Clause 5.6) are not required.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the GlucoTrack CGM (continuous glucose monitor display, Class B):

"The GlucoTrack CGM software development conforms to ISO 14971-1, with risk management per ISO 14971:2019."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 14971-1" which is incorrect. ISO 14971 is a single-part standard. The correct citation is ISO 14971:2019. All references must be corrected.


[System] You are an IEC 62304 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

[User]
Review this documentation excerpt for the PillRemind (medication reminder app, Class A):

"Problem resolution is established for the PillRemind. Problems are reported. Problems are investigated. Problems are resolved. Problems are tracked. Problem resolution follows IEC 62304 Clause 9."

[Assistant]
Verdict: FAIL
Note: The documentation section exhibits repetitive structure. Sentences follow the same structure and convey the same meaning. Each paragraph should cover a distinct aspect with varied structure. Content should be consolidated and each sentence should contribute unique, specific information about the PillRemind.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SDP section on change control and trend analysis for problems for VibeCheck Vibration Analyzer, a Class A Vibration Analysis Instrument Firmware. Reference IEC 62304 Clauses 9.4, 9.6.
Portable vibration analysis firmware for predictive maintenance of industrial rotating machinery. FFT analysis of accelerometer data.

[Assistant] Content: All VibeCheck Vibration Analyzer problem corrections enter the change control process per Clause 9.4 before integration into the baseline. Trend analysis per Clause 9.6 tracks defect density, time-to-resolution, and defect category distribution across the Vibration Analysis Instrument Firmware development lifecycle to drive process improvement.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a FMEA section on failure mode identification approach for FleetTrack GPS Tracking Module, a Class A Fleet GPS Tracking Firmware. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

[Assistant] Content: The failure mode identification for the FleetTrack GPS Tracking Module Fleet GPS Tracking Firmware per Clause 7.1.2 considers every processing step from input to output. Failure categories include data corruption, computation error, timing fault, and communication loss. Each failure mode is linked to its potential causes, including SOUP defects evaluated per Clause 7.1.3.


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a FMEA section on failure mode identification approach for NeoVent Neonatal Ventilator, a Class C Neonatal Ventilator Firmware. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Neonatal ventilator firmware supporting CPAP, NIPPV, and conventional ventilation for extremely premature infants. Tidal volumes as low as 2 mL.

[Assistant] Content: Software failure modes in the NeoVent Neonatal Ventilator are identified using a structured approach per Clause 7.1.2: each software item is analyzed for what could go wrong (the failure mode), why it could go wrong (the cause), and what would happen (the effect). SOUP component anomalies per Clause 7.1.3 are included as potential failure causes.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SRS section on external system communication requirements for HeartView Resting HR Display, a Class A Heart Rate Display Firmware. Reference IEC 62304 Clause 5.2.2.
Wearable firmware that shows resting heart rate on a small OLED screen. Read-only display with no arrhythmia detection or clinical alerts.

[Assistant] Content: The HeartView Resting HR Display Heart Rate Display Firmware external communication requirements cover data exchange with remote systems. Each requirement specifies the message format, transport protocol, retry policy, and failure mode behavior, ensuring the Heart Rate Display Firmware degrades safely if communication is disrupted.


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a THREAT section on system description for threat modeling for RemotICU Continuous Monitoring Hub, a Class B Edge-to-Cloud ICU Monitoring Gateway. Reference IEC 62304 Clause 5.2.1.
Edge gateway collecting data from bedside monitors (SpO2, HR, BP, ventilator) and streaming to cloud for trending, alerting, and tele-ICU review.

[Assistant] Content: The RemotICU Continuous Monitoring Hub threat model system description per IEC 81001-5-1:2021 identifies the Edge-to-Cloud ICU Monitoring Gateway as the subject, with trust boundaries at each external interface. Assets include software integrity, data confidentiality, and service availability during Aggregating bedside monitor data at the edge and streaming to cloud for tele-ICU clinical oversight.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SDP section on lightweight review process for Class A for InhaleSense Smart Inhaler Tracker, a Class A Smart Inhaler Adherence Tracker. Reference IEC 62304 Clause 5.1.1.
Firmware for a smart inhaler attachment detecting actuation events, tracking medication adherence, and syncing data to a mobile app and clinician portal.

[Assistant] Content: The InhaleSense Smart Inhaler Tracker review process is proportionate to the Class A risk level. The project lead reviews each deliverable for technical accuracy, and the quality representative verifies compliance with SOPs. Reviews are documented but do not require independent technical review of the Smart Inhaler Adherence Tracker verification activities.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the BloodBank Manager (blood bank inventory system, Class A):

"SOUP functional requirements for the BloodBank Manager are specified per Clause 5.3.3."

[Assistant]
Verdict: FAIL
Note: Content mandates architectural design documentation for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Architectural design (Clause 5.3) is not required for Class A.


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SRS section on requirements conventions and identification scheme for LabStream LIS Middleware, a Class A Laboratory Information Middleware. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Middleware software connecting laboratory analyzers to the hospital LIS. Routes results, applies auto-validation rules, and flags critical values.

[Assistant] Content: Each requirement for the LabStream LIS Middleware is assigned a unique identifier and tagged with its type (functional, performance, interface, or safety) per Clause 5.2.2. Requirements are written in "shall" statements that are individually testable. The requirement set is baselined and controlled under the change management process.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SDP section on change control process for CleanRoom Particle Counter Logger, a Class A Cleanroom Environmental Logger. Reference IEC 62304 Clauses 8.2, 8.2.1.
Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

[Assistant] Content: Change control for the CleanRoom Particle Counter Logger Cleanroom Environmental Logger follows Clause 8.2. Each change request is assessed for safety impact, assigned a priority, and tracked to closure. Changes to safety-related requirements or risk control measures require re-evaluation of the ISO 14971 risk analysis before implementation.


[System] You are an IEC 62304 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

[User]
Review this documentation excerpt for the BloodBank Manager (blood bank inventory system, Class A):

"Unit verification per IEC 62304 Clause 5.5 requires testing of all BloodBank Manager software units."

[Assistant]
Verdict: FAIL
Note: Content mandates unit testing for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Unit verification (Clause 5.5) is not required for Class A.


[System] You are an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-FUNC-005: "display update rate for Renal Dose Adjustment Calculator" (Category: functional)
Project: RenalDose Renal Adjustment Calculator | Renal Dose Adjustment Calculator | Class B
Calculating renal-adjusted medication doses based on estimated glomerular filtration rate. Calculator adjusting medication doses for patients with impaired renal function based on eGFR.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: The RenalDose Renal Adjustment Calculator shall update the displayed values on the manual input at intervals no greater than the specified refresh period.
Rationale: Display freshness is critical for the Renal Dose Adjustment Calculator to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: End-to-end latency from data acquisition to display update does not exceed the specified limit for 99.9% of samples.
Source: User need


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on risk control requirements traceability for NeoFeed Neonatal Feeding Pump, a Class C Neonatal Feeding Pump Firmware. Reference IEC 62304 Clause 5.2.3.
Syringe pump firmware for precise enteral feeding in NICU patients. Flow accuracy is critical for extremely low birth weight infants.

[Assistant] Content: Software-implemented risk controls for the NeoFeed Neonatal Feeding Pump are documented as explicit requirements per Clause 5.2.3. Traceability from the ISO 14971 risk analysis through the SRS to verification test cases ensures that every risk control measure is implemented and verified in the Neonatal Feeding Pump Firmware.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the BloodBank Manager (blood bank inventory system, Class A):

"For the BloodBank Manager, ISO 14971:2019 risk management is integrated with the IEC 62304 software lifecycle. Risk control measures identified in the risk analysis are incorporated as software requirements per Clause 5.2.3. The medical device risk analysis is re-evaluated per Clause 5.2.4 after requirements changes."

[Assistant]
Verdict: PASS
Note: Content correctly references ISO 14971:2019; risk management content follows ISO 14971 framework. Standards references are accurate.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the CardioPulse Monitor (cardiac rhythm monitor, Class B):

"IEC 62304 Clause 5.7.6 requires the CardioPulse Monitor to implement data archival."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.7.6 which does not exist. Clause 5.7 has 5.7.1 through 5.7.5 only. The reference must be corrected to a valid clause number.


[System] You are a requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-DATA-003: "stored data corruption detection" (Category: data)
Project: IncidentReport Clinical Event Logger | Incident Reporting System | Class A
Submission and routing of clinical incident reports for quality review. Web form for staff to submit clinical incident reports. Data entry and routing only, no analysis.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: Data integrity of all stored records in the Incident Reporting System shall be verified using CRC or equivalent checksums upon read-back.
Rationale: Corrupted data must be identified to prevent clinical decisions based on unreliable measurements.
Priority: Mandatory
Acceptance Criterion: Integrity check correctly identifies all corrupted records with zero false positives on uncorrupted data.
Source: System requirement


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the OxyPure Controller (oxygen concentrator controller, Class C):

"The OxyPure Controller follows the software lifecycle. The OxyPure Controller implements the lifecycle processes. The OxyPure Controller adheres to the lifecycle model. The OxyPure Controller conforms to the lifecycle framework."

[Assistant]
Verdict: FAIL
Note: The documentation section exhibits repeated project name. The project name 'OxyPure Controller' appears excessively. Sentences repeat the same assertion about the oxygen concentrator controller in different words. Content should be consolidated and each sentence should contribute unique, specific information about the OxyPure Controller.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SDP section on internal SOPs and procedures for StepSync Activity Tracker, a Class A Wellness Activity Display App. Reference IEC 62304 Clause 5.1.2.
Mobile app displaying daily step count, distance, and calories from a wrist-worn accelerometer. Read-only display with no clinical interpretation.

[Assistant] Content: Internal procedures governing StepSync Activity Tracker development include SOP-010 (Software Development Planning), SOP-011 (Risk Management Planning), SOP-012 (Configuration Management), and SOP-013 (Software Verification Planning). These standard operating procedures are maintained under the company's ISO 13485 quality management system and provide detailed work instructions for each lifecycle activity.


[System] You are a requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-FUNC-004: "initialization integrity checks" (Category: functional)
Project: FleetTrack GPS Tracking Module | Fleet GPS Tracking Firmware | Class A
Real-time GPS tracking and geofence monitoring of fleet vehicles. Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: A power-on self-test shall validate GNSS module communication, memory integrity, and LTE-M cellular connectivity before the Fleet GPS Tracking Firmware transitions to its operational state.
Rationale: A power-on self-test confirms hardware and software readiness before the Fleet GPS Tracking Firmware begins use.
Priority: Mandatory
Acceptance Criterion: All fault injection scenarios are detected with 100% reliability across 50 test iterations.
Source: System requirement


[System] You are a requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-DATA-002: "data integrity validation" (Category: data)
Project: WeightAlert Neonatal Scale | Neonatal Scale Firmware | Class B
Precision weight measurement for neonatal patients with change-rate alerting. Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: Data integrity of all stored records in the Neonatal Scale Firmware shall be verified using CRC or equivalent checksums upon read-back.
Rationale: Corrupted data must be identified to prevent clinical decisions based on unreliable measurements.
Priority: Mandatory
Acceptance Criterion: Intentionally corrupted records are detected and flagged with 100% detection rate across 100 injected corruption events.
Source: System requirement


[System] You are a requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-PERF-001: "data processing timing constraint" (Category: performance)
Project: DoseVerify In-Vivo Dosimetry System | In-Vivo Dosimetry Verification Software | Class C
Real-time verification of delivered radiation dose using in-vivo dosimeter measurements during treatment. Software calculating real-time delivered dose from in-vivo dosimeter readings during radiation therapy. Dose verification for patient safety.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: End-to-end latency from MOSFET dosimeters data acquisition to output presentation shall not exceed the specified limit under normal operating conditions.
Rationale: Bounded processing latency ensures the In-Vivo Dosimetry Verification Software provides readings reflecting the current state without clinically significant delay.
Priority: Mandatory
Acceptance Criterion: Worst-case latency measured under maximum load conditions does not exceed the specified absolute maximum.
Source: System requirement


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SAD section on SOUP component integration and requirements for TransVent Transport Ventilator, a Class C Transport Ventilator Firmware. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Portable transport ventilator firmware for ambulance and helicopter use. Must maintain ventilation under vibration and altitude changes.

[Assistant] Content: Third-party software components used in the TransVent Transport Ventilator are documented per Clause 5.3.3, including functional and performance requirements imposed on each SOUP item. Hardware and software dependencies per Clause 5.3.4 are recorded to ensure that the STM32H7 environment satisfies all SOUP prerequisites.


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on lightweight review process for Class A for SunGuard UV Index Display, a Class A UV Exposure Display Firmware. Reference IEC 62304 Clause 5.1.1.
Wearable UV index monitor with an OLED display showing current UV exposure level. Informational only, no sunburn prevention claims.

[Assistant] Content: The SunGuard UV Index Display SDP and its associated deliverables are reviewed by the project lead and quality assurance representative. Given the Class A classification, a lightweight review process is appropriate: the reviewer confirms that all required sections are addressed, requirements are traceable, and system-level verification is planned. No independent technical reviewer is required.


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SDP section on change control and trend analysis for problems for VitalBoard Patient Summary, a Class A Patient Summary Dashboard. Reference IEC 62304 Clauses 9.4, 9.6.
Dashboard displaying patient vital signs history retrieved from the EMR. View-only with no alerting or trend analysis.

[Assistant] Content: Corrections to the VitalBoard Patient Summary follow the change control process per Clause 9.4, with regression testing proportional to the scope of the change. Problem reports are periodically analyzed for trends per Clause 9.6 to identify systemic issues in the development process that might affect the quality of the Patient Summary Dashboard.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the NurseCall Hub (patient call system dashboard, Class A):

"Independent verification of all NurseCall Hub development artifacts is required per Class C rigor."

[Assistant]
Verdict: FAIL
Note: Content mandates independent review for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Independent review is required only for Class C (Clause 5.5.4, 5.7.4).


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the VentAssist Pro (ICU ventilator controller, Class C):

"ISO 13485-2 Section 5.7 requires all software units to be verified."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 13485-2" which is incorrect. ISO 13485 has no Part 2. All references must be corrected.


[System] You are a requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-FUNC-002: "user-configurable operating parameters" (Category: functional)
Project: RetinaStim Visual Prosthesis Controller | Retinal Prosthesis Controller Firmware | Class C
Processing camera input and driving retinal implant electrode stimulation patterns for artificial vision. Firmware driving a retinal implant electrode array based on camera input processing. Stimulation errors could cause retinal damage.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: Operating parameters of the Retinal Prosthesis Controller Firmware shall be user-configurable within validated ranges and stored in non-volatile memory.
Rationale: Configurable parameters allow the Retinal Prosthesis Controller Firmware to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: Configuration round-trip test: set, power-cycle, read-back for all parameters with 100% accuracy.
Source: User need


[System] You are a requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-PERF-001: "end-to-end processing latency" (Category: performance)
Project: BreathEasy Air Quality Display | Environmental Air Quality Display | Class A
Informational display of indoor air quality metrics for general awareness. Indoor air quality monitor displaying PM2.5, CO2, and temperature on an LCD. Informational display only with no clinical guidance.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: The BreathEasy Air Quality Display shall process acquired data and update the output within the specified end-to-end latency from sample acquisition to display update.
Rationale: Bounded processing latency ensures the Environmental Air Quality Display provides readings reflecting the current state without clinically significant delay.
Priority: Mandatory
Acceptance Criterion: Worst-case latency measured under maximum load conditions does not exceed the specified absolute maximum.
Source: System requirement


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SRS section on functional requirements overview for ConveyorGuard Safety Interlock System, a Class A Conveyor Safety Interlock Software. Reference IEC 62304 Clause 5.2.2.
Safety PLC program monitoring conveyor belt guard positions, emergency stops, and light curtains. Functional safety application.

[Assistant] Content: Functional requirements for the ConveyorGuard Safety Interlock System are derived from the system requirements for Monitoring safety interlocks and emergency stops on industrial conveyor systems and from risk control measures identified in the ISO 14971 analysis. Each requirement specifies a single function of the Conveyor Safety Interlock Software with measurable acceptance criteria.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the EchoAssist (echocardiogram analysis aid, Class B):

"The development plan references IEC 62304 Clause 4.5 and Clause 5.1.12 for the EchoAssist."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 4.5 and 5.1.12, neither of which exists. Clause 4 only has 4.1, 4.2, 4.3. Clause 5.1 has 5.1.1 through 5.1.11 only. All clause references must be corrected.


[System] You are an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-PERF-001: "output precision and accuracy" (Category: performance)
Project: CardioCloud ECG Analysis Service | Cloud ECG Analysis SaMD | Class B
Automated arrhythmia detection and ECG interpretation as a cloud service for remote clinics. Cloud SaaS platform receiving 12-lead ECG recordings from clinics, running automated arrhythmia detection, and returning annotated results via FHIR API.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: The CardioCloud ECG Analysis Service shall maintain measurement accuracy within the specified tolerance across the full operating range of the primary sensor.
Rationale: Measurement accuracy directly affects clinical decisions based on the Cloud ECG Analysis SaMD output and is a key factor in the risk profile.
Priority: Mandatory
Acceptance Criterion: Statistical analysis of 500 measurements shows mean error within tolerance and standard deviation within specified limits.
Source: Regulatory


[System] You are an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-FUNC-003: "device configuration management" (Category: functional)
Project: FleetTrack GPS Tracking Module | Fleet GPS Tracking Firmware | Class A
Real-time GPS tracking and geofence monitoring of fleet vehicles. Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: Operating parameters of the Fleet GPS Tracking Firmware shall be user-configurable within validated ranges and stored in non-volatile memory.
Rationale: Parameter flexibility is essential for the Fleet GPS Tracking Firmware to meet varying clinical requirements across deployment sites.
Priority: Mandatory
Acceptance Criterion: Configuration round-trip test: set, power-cycle, read-back for all parameters with 100% accuracy.
Source: User need


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SDP section on requirements verification approach for MedImage PACS Viewer, a Class A Web PACS Image Viewer. Reference IEC 62304 Clause 5.2.6.
Web-based PACS viewer enabling radiologists to review DICOM images with standard tools (windowing, measurement, MPR). View-only, no AI or diagnostic processing.

[Assistant] Content: Requirements verification for the MedImage PACS Viewer is conducted per Clause 5.2.6 before the requirements baseline is established. The review confirms completeness, consistency, and testability. Any requirement failing these criteria is returned for rework before the Web PACS Image Viewer proceeds to design.


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on primary international standards applicable to development for NeuroTune DBS Programmer, a Class C Deep Brain Stimulator Programmer App. Reference IEC 62304 Clause 5.1.2.
Tablet application programming deep brain stimulation implants for movement disorders. Stimulation parameter errors could cause neurological harm.

[Assistant] Content: Applicable standards for the NeuroTune DBS Programmer include IEC 62304:2006+AMD1:2015 (software lifecycle), ISO 14971:2019 (risk management), ISO 13485:2016 (quality management), and IEC 62366-1:2015+AMD1:2020 (usability engineering). These standards collectively define the processes, documentation, and verification expectations for the Deep Brain Stimulator Programmer App.


[System] You are a medical device regulatory standards expert with comprehensive knowledge of IEC 62304, ISO 14971, ISO 13485, IEC 62366-1, IEC 82304-1, IEC 81001-5-1, IEC 60601-1 and its sub-parts, and associated regulatory guidance. Provide accurate standards references. Never fabricate clause numbers or standard sub-parts.

[User] Can I cite IEC 14971 in my documentation?

[Assistant] No. The correct prefix is ISO, not IEC. The standard is ISO 14971:2019, published by the International Organization for Standardization (ISO).


[System] You are a requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-INTF-002: "clinical system integration interface" (Category: interface)
Project: InhaleSense Smart Inhaler Tracker | Smart Inhaler Adherence Tracker | Class A
Detecting inhaler actuation events and tracking medication adherence for asthma management. Firmware for a smart inhaler attachment detecting actuation events, tracking medication adherence, and syncing data to a mobile app and clinician portal.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: Data interoperability with clinical information systems shall be provided through BLE 5.0, supporting standard message formats.
Rationale: External system connectivity is required for the Smart Inhaler Adherence Tracker to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Format validation passes for all message types with correct field encoding verified.
Source: User need


[System] You are a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a THREAT section on STRIDE mitigations traced to requirements for LinacControl Beam Delivery System, a Class C Linear Accelerator Control Software. Reference IEC 62304 Clause 5.2.3.
Software controlling linear accelerator beam delivery during radiation therapy. Beam-on errors could deliver lethal radiation doses.

[Assistant] Content: Threat-to-mitigation traceability for the LinacControl Beam Delivery System Linear Accelerator Control Software is maintained per Clause 5.2.3. Each STRIDE threat is mapped to a security requirement, an implementation, and a verification test. This traceability ensures no identified threat lacks a corresponding software control.


[System] You are a requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-FUNC-004: "alarm threshold management" (Category: functional)
Project: PharmaSafe CDSS | Clinical Decision Support System | Class B
Real-time clinical decision support for medication safety including interaction checking and dose validation. Clinical decision support system integrated into hospital EMR providing real-time drug-drug interaction alerts, allergy checking, and dosing guidance.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: The PharmaSafe CDSS shall generate audible and visual alarms within the specified response time when a monitored parameter exceeds its configured threshold.
Rationale: Timely alarm generation is essential for the Clinical Decision Support System to alert clinicians to abnormal conditions requiring intervention.
Priority: Mandatory
Acceptance Criterion: Alarm triggers within the specified response time of a threshold crossing, measured over 50 test crossings with no false negatives.
Source: Risk control


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the PhysioTrack Rehab (rehabilitation tracking system, Class B):

"In accordance with IEC 62304-3, verification activities include system testing."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304-3" which is incorrect. IEC 62304 has no Part 3. All references must be corrected.


[System] You are an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-DATA-002: "measurement record integrity" (Category: data)
Project: SurgiPlan 3D Surgical Planner | 3D Surgical Planning SaMD | Class B
Preoperative 3D planning of joint replacement procedures with implant sizing and alignment. Desktop SaMD for orthopedic surgeons to plan joint replacement procedures on 3D CT reconstructions. Outputs implant sizing and positioning specifications.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: The SurgiPlan 3D Surgical Planner shall validate the integrity of stored data using checksums, detecting and reporting any corruption of measurement records.
Rationale: Data integrity mechanisms ensure measurement records retrieved from the 3D Surgical Planning SaMD are trustworthy for clinical review.
Priority: Mandatory
Acceptance Criterion: Intentionally corrupted records are detected and flagged with 100% detection rate across 100 injected corruption events.
Source: System requirement


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a THREAT section on threat model data flow decomposition for VitalPulse SpO2 Monitor, a Class B Pulse Oximeter Firmware. Reference IEC 62304 Clause 5.2.2.
Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

[Assistant] Content: The VitalPulse SpO2 Monitor data flow diagrams for threat analysis map all data movement within and across the Pulse Oximeter Firmware boundary. Trust boundaries are placed at external interfaces (I2C, UART to display), persistent storage, and inter-process communication points.


[System] You are an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-FUNC-003: "device configuration management" (Category: functional)
Project: NeoFeed Neonatal Feeding Pump | Neonatal Feeding Pump Firmware | Class C
Precise enteral feeding delivery for neonatal patients with sub-milliliter accuracy. Syringe pump firmware for precise enteral feeding in NICU patients. Flow accuracy is critical for extremely low birth weight infants.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: Configuration changes to the NeoFeed Neonatal Feeding Pump shall be validated against allowed ranges before acceptance and persisted to survive power loss.
Rationale: Configurable parameters allow the Neonatal Feeding Pump Firmware to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: Configuration round-trip test: set, power-cycle, read-back for all parameters with 100% accuracy.
Source: User need


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SRS section on purpose of the SRS document for StrokeAlert CT Perfusion Analyzer, a Class C AI Stroke Triage CT Perfusion SaMD. Reference IEC 62304 Clause 5.2.1.
Time-critical cloud SaMD processing CT perfusion scans to generate ischemic core and penumbra maps for acute stroke triage. Results pushed to mobile app within 5 minutes.

[Assistant] Content: This document specifies the software requirements for the StrokeAlert CT Perfusion Analyzer AI Stroke Triage CT Perfusion SaMD as required by IEC 62304 Clause 5.2.1. It serves as the primary input to design and the primary reference for verification test case derivation. All requirements are verifiable, traceable, and configuration-controlled.


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SRS section on baseline security requirements for InsuPrecise Insulin Pump Controller, a Class C Insulin Pump Controller Firmware. Reference IEC 62304 Clause 5.2.2.
Embedded firmware controlling insulin delivery in a patch-type insulin pump. Incorrect dosing could cause severe hypoglycemia or diabetic ketoacidosis.

[Assistant] Content: The InsuPrecise Insulin Pump Controller security requirements cover confidentiality, integrity, and availability of the Insulin Pump Controller Firmware and its data per IEC 81001-5-1:2021. Requirements specify access control mechanisms, encryption for data at rest and in transit, session management, and audit logging.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the WoundTrack (wound measurement imaging system, Class B):

"Risk control measures are implemented per ISO 13485-1 Clause 7."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 13485-1" which is incorrect. ISO 13485 is a single-part standard. The correct citation is ISO 13485:2016. All references must be corrected.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the SleepWell (sleep quality display app, Class A):

"The regulatory framework for the SleepWell references IEC 62304:2006+AMD1:2015 Clauses 4 through 9 as applicable to Class A software. ISO 14971:2019 governs the risk management process. The quality system operates under ISO 13485:2016."

[Assistant]
Verdict: PASS
Note: Content correctly limits Class A to system-level verification; uses the correct IEC 62304 citation; correctly references ISO 14971:2019. Standards references are accurate.


[System] You are an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a TRACE section on purpose and scope of the traceability matrix for PharmLog Medication History Viewer, a Class A Medication History Viewer. Reference IEC 62304 Clause 5.7.1.
Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

[Assistant] Content: Traceability for the PharmLog Medication History Viewer per Clause 5.7.1 links system requirements to software requirements, software requirements to design elements, and design elements to verification test cases. The matrix serves as the primary evidence that the Medication History Viewer verification is complete and that no requirement is unaddressed.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the PillRemind (medication reminder app, Class A):

"IEC 62304:2022 Section 5.3 requires all software units to be verified."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304:2022" which is incorrect. No 2022 edition exists. Current: IEC 62304:2006+AMD1:2015. All references must be corrected.


[System] You are an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-SEC-001: "authentication for configuration access" (Category: security)
Project: FleetTrack GPS Tracking Module | Fleet GPS Tracking Firmware | Class A
Real-time GPS tracking and geofence monitoring of fleet vehicles. Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

Output fields:
Description: 1-2 specific, measurable sentences
Rationale: 1 sentence explaining why this requirement exists
Priority: "Mandatory" or "Desirable" or "Optional"
Acceptance Criterion: Measurable test criterion
Source: "User need" or "System requirement" or "Risk control" or "Regulatory"

[Assistant]
Description: User authentication shall be enforced for all configuration changes to the FleetTrack GPS Tracking Module, with credential validation before granting access.
Rationale: Access control prevents unauthorized modification of the Fleet GPS Tracking Firmware operating parameters.
Priority: Mandatory
Acceptance Criterion: Brute-force protection activates after the specified number of failed authentication attempts.
Source: Risk control


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the RadView DICOM (DICOM image viewer, Class A):

"REQ-SRS-078: The RadView DICOM shall maintain data integrity during concurrent access by multiple users. No data corruption or loss shall occur. Acceptance criterion: execute concurrent read/write operations and verify data consistency. Priority: Mandatory. Source: System requirement."

[Assistant]
Verdict: PASS
Note: Content requirement is properly structured with measurable acceptance criteria. Standards references are accurate.


[System] You are a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the HydroLog (hydration tracking wellness app, Class A):

"Post-market activities are conducted as required by applicable regulations. Feedback mechanisms are established per best practices for the HydroLog."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "best practices", "as required by" provide no project-specific information about the HydroLog hydration tracking wellness app. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.