[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: PulseRing Smart Ring Monitor | Wearable Smart Ring Firmware + Companion App | Class B
Continuous photoplethysmography-based heart rate and SpO2 monitoring via wearable ring with mobile companion. Wearable smart ring firmware measuring continuous PPG for heart rate and SpO2 with BLE streaming to companion mobile app for trend 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 PulseRing Smart Ring Monitor shall detect corrupted measurement records through integrity checking and flag affected entries for review.
Rationale: Data integrity mechanisms ensure measurement records retrieved from the Wearable Smart Ring Firmware + Companion App are trustworthy for clinical review.
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 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 ConsentView Informed Consent Archive, a Class A Consent Document Viewer. Reference IEC 62304 Clause 5.2.2.
Web portal for patients and staff to view signed informed consent documents. Read-only document viewer.

[Assistant] Content: The ConsentView Informed Consent Archive Consent Document Viewer presents information to the user via REST API and accepts user input through defined interaction patterns. User interaction requirements are traceable to the usability engineering file per IEC 62366-1:2015+AMD1:2020.


[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 baseline security requirements for PainScale Digital Assessment Tool, a Class B Pain Assessment Tool. Reference IEC 62304 Clause 5.2.2.
Web app for standardized pain assessment using validated scales (VAS, NRS, McGill). Records longitudinal pain data for treatment monitoring.

[Assistant] Content: Security requirements for the PainScale Digital Assessment Tool address authentication, data protection, and access control for the Pain Assessment Tool. All persistent data is encrypted at rest, and data in transit over FHIR API uses transport layer encryption. Security requirements are aligned with IEC 81001-5-1:2021.


[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-SEC-001: "authentication for configuration access" (Category: security)
Project: ScheduleSync Appointment Manager | Appointment Scheduling System | Class A
Administrative scheduling and calendar management for clinical appointments. Web application for scheduling patient appointments across multiple clinics. Administrative scheduling only, no clinical workflow.

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 ScheduleSync Appointment Manager, with credential validation before granting access.
Rationale: Unauthorized configuration changes to the Appointment Scheduling System could compromise its intended function or patient safety.
Priority: Mandatory
Acceptance Criterion: Brute-force protection activates after the specified number of failed authentication attempts.
Source: Risk control


[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 operational context and user population for PharmLog Medication History Viewer, a Class A Medication History Viewer. Reference IEC 62304 Clause 5.2.2.
Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

[Assistant] Content: Operational context: the PharmLog Medication History Viewer is a Medication History Viewer used for Read-only display of medication dispensing history. The software executes on iOS and interfaces with external inputs for data acquisition. The user population and use environment define the requirements for usability, reliability, and performance.


[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):

"Compliance with IEC 62304 Clause 5.7.6 (detailed design verification) and Clause 5.5.2.1 (continuous monitoring) is demonstrated."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.7.6 and 5.5.2.1, neither of which exists. Clause 5.7 has 5.7.1 through 5.7.5 only. IEC 62304 has no four-level numbering. All clause 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-SEC-002: "user identity verification" (Category: security)
Project: SleepScore Apnea Screening Tool | Sleep Apnea Screening App | Class B
Screening for sleep apnea indicators using smartphone audio analysis, requiring sleep study confirmation. Mobile app analyzing overnight audio recordings to screen for obstructive sleep apnea indicators. Screening only, not diagnostic.

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 SleepScore Apnea Screening Tool, with credential validation before granting access.
Rationale: Unauthorized configuration changes to the Sleep Apnea Screening App 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 an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on problem reporting and investigation for InfuRate IV Flow Calculator, a Class B Infusion Rate Calculator. Reference IEC 62304 Clauses 9.1, 9.2.
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 problem reporting process per Clause 9.1 captures all software anomalies with sufficient detail for reproduction and root cause investigation. Clause 9.2 investigation assesses whether the problem represents a safety risk, determines the affected scope within the Infusion Rate Calculator, and identifies the corrective action 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 THREAT section on system description for threat modeling for TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clause 5.2.1.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

[Assistant] Content: Threat modeling for the TriageAI Emergency Triage Assistant begins with a system description identifying entry points, data stores, and trust boundaries of the ED Triage Decision Support App. The model covers the iPad web app execution environment, all manual input, EMR integration via FHIR interfaces, and persistent data stores.


[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):

"Software maintenance is planned. Software maintenance activities are defined. The maintenance plan covers all aspects. Maintenance follows the plan. The OxyPure Controller maintenance is documented. Maintenance is performed."

[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 OxyPure Controller.


[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 safety requirements for Class A -- confirms no safety functions for VibeCheck Vibration Analyzer, a Class A Vibration Analysis Instrument Firmware. Reference IEC 62304 Clauses 5.2.2, 5.2.3.
Portable vibration analysis firmware for predictive maintenance of industrial rotating machinery. FFT analysis of accelerometer data.

[Assistant] Content: The VibeCheck Vibration Analyzer is classified as Safety Class A and contains no software-implemented safety functions. The Vibration Analysis Instrument Firmware provides informational output only for Vibration spectrum analysis of industrial machinery for predictive maintenance and does not control any therapeutic function, generate clinical alarms, or make diagnostic decisions. No risk control measures are implemented in software per Clause 5.2.3.


[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-003: "data export and interoperability" (Category: interface)
Project: PowerTrack UPS Monitor | UPS Monitoring Software | Class A
Logging and displaying UPS status for facility infrastructure monitoring. Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

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 PowerTrack UPS Monitor shall exchange data with external systems via SNMP using the specified message format with error handling.
Rationale: External system connectivity is required for the UPS Monitoring Software 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 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 EchoAssist software architecture defines three software items with documented interfaces per Clause 5.3.2. Data formats, protocols, and error handling are specified for each interface. SOUP components are identified per Clause 5.3.3."

[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 PacePilot (pacemaker programmer, Class C):

"Risk control measures are implemented per ISO 62304 Clause 7."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 62304" which is incorrect. Wrong prefix. The correct standard is IEC 62304, not ISO 62304. All references must be corrected.


[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 SOUP identification and management for ConsentView Informed Consent Archive, a Class A Consent Document Viewer. Reference IEC 62304 Clause 8.1.2.
Web portal for patients and staff to view signed informed consent documents. Read-only document viewer.

[Assistant] Content: The ConsentView Informed Consent Archive SOUP register identifies every third-party component deployed in the Consent Document Viewer, including version, source, and functional role. Updates to SOUP items trigger re-evaluation of known anomalies per Clause 7.1.3 and regression testing proportional to the scope of change.


[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 DoseLog Radiation Badge Reader, a Class A Dosimetry Data Logger. Reference IEC 62304 Clause 5.1.1.
Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

[Assistant] Content: A streamlined iterative model governs the DoseLog Radiation Badge Reader development. Given the Class A classification, the lifecycle omits formal architecture verification and detailed design phases, proceeding directly from requirements to implementation and then to system-level verification of the Dosimetry Data Logger on Windows desktop.


[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: "initialization integrity checks" (Category: functional)
Project: ECGInsight Rhythm Interpreter | ECG Interpretation Service | Class B
Automated preliminary interpretation of 12-lead ECG recordings for physician review and overread. Cloud service analyzing 12-lead ECG recordings and generating preliminary rhythm interpretations for physician 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: A power-on self-test shall validate primary sensor communication, memory integrity, and DICOM ECG input connectivity before the ECG Interpretation Service transitions to its operational state.
Rationale: Startup verification prevents the ECG Interpretation Service from operating with undetected faults that could affect output accuracy.
Priority: Mandatory
Acceptance Criterion: All fault injection scenarios are detected with 100% reliability across 50 test iterations.
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 SleepWell (sleep quality display app, Class A):

"Problem resolution is established for the SleepWell. 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 SleepWell.


[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 HeartLink (cardiac telemetry system, Class B):

"Applicable standards for the HeartLink are: IEC 62304:2006+AMD1:2015 for the software development lifecycle, ISO 14971:2019 for risk management, and ISO 13485:2016 for the quality management system. No sub-part standards are referenced as IEC 62304 and ISO 14971 are each single-part standards."

[Assistant]
Verdict: PASS
Note: Content uses the correct IEC 62304 citation; correctly references ISO 14971:2019; correctly references ISO 13485:2016. 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 THREAT section on system description for threat modeling for LinacControl Beam Delivery System, a Class C Linear Accelerator Control Software. Reference IEC 62304 Clause 5.2.1.
Software controlling linear accelerator beam delivery during radiation therapy. Beam-on errors could deliver lethal radiation doses.

[Assistant] Content: The LinacControl Beam Delivery System threat model system description per IEC 81001-5-1:2021 identifies the Linear Accelerator Control Software as the subject, with trust boundaries at each external interface. Assets include software integrity, data confidentiality, and service availability during Controlling radiation beam delivery including gantry position, collimator settings, and dose monitoring.


[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 risk evaluation and anomaly management for RadView DICOM Viewer, a Class A Medical Image Viewer. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Desktop application for viewing DICOM medical images. Display-only with standard windowing controls. No CAD or diagnostic measurement tools.

[Assistant] Content: Risk evaluation of SOUP in the RadView DICOM Viewer follows Clause 7.1.3. Published anomaly lists are reviewed for each SOUP item deployed in the Medical Image Viewer. Anomalies relevant to Read-only display of medical images for reference viewing are entered into the risk management file, and mitigations are implemented where the residual risk is unacceptable.


[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):

"This Software Development Plan for the DermaScan AI is prepared in compliance with IEC 62304:2006+AMD1:2015 and ISO 14971:2019. Usability engineering follows IEC 62366-1:2015+AMD1:2020."

[Assistant]
Verdict: PASS
Note: Content 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 SDP section on problem reporting and investigation for OBDView Diagnostic Display, a Class A Vehicle Diagnostic Display App. Reference IEC 62304 Clauses 9.1, 9.2.
Mobile app connecting to vehicle OBD-II port to display engine parameters, fault codes, and emissions data.

[Assistant] Content: The OBDView Diagnostic Display problem reporting process per Clause 9.1 captures all software anomalies with sufficient detail for reproduction and root cause investigation. Clause 9.2 investigation assesses whether the problem represents a safety risk, determines the affected scope within the Vehicle Diagnostic Display App, and identifies the corrective action 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 SRS section on requirements conventions and identification scheme for AssetTrack Equipment Inventory, a Class A Equipment Inventory System. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management only.

[Assistant] Content: Requirements for the AssetTrack Equipment Inventory Equipment Inventory System are documented per Clause 5.2.2 with clear acceptance criteria enabling direct derivation of test cases. Each requirement traces backward to its source and forward to its verification activity in the traceability matrix.


[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 purpose of the architecture document for WoundTrack Healing Analyzer, a Class B Wound Assessment App. Reference IEC 62304 Clause 5.3.1.
Mobile app photographing wounds and measuring area/perimeter over time to track healing progress for clinician review.

[Assistant] Content: The WoundTrack Healing Analyzer Software Architecture Document establishes the high-level design structure of the Wound Assessment App per Clause 5.3.1. It defines the decomposition into software items, their interfaces, and the rationale for design decisions including technology choices and architectural patterns on Android.


[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 HeartView Resting HR Display, a Class A Heart Rate Display Firmware. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Wearable firmware that shows resting heart rate on a small OLED screen. Read-only display with no arrhythmia detection or clinical alerts.

[Assistant] Content: Software failure modes in the HeartView Resting HR Display 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 SDP section on change control and trend analysis for problems for TempWatch Body Temperature Logger, a Class A Temperature Logging Firmware. Reference IEC 62304 Clauses 9.4, 9.6.
Firmware for a wearable temperature patch that logs skin temperature over 24 hours and displays trends. No fever detection or alerts.

[Assistant] Content: Corrections to the TempWatch Body Temperature Logger 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 Temperature Logging Firmware.


[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):

"In accordance with ISO 13485-1, verification activities include system testing."

[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 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 configuration identification approach for PhysioTrack Rehabilitation Monitor, a Class B Physical Therapy Tracking System. Reference IEC 62304 Clauses 8.1, 8.1.1.
Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

[Assistant] Content: All artifacts produced during PhysioTrack Rehabilitation Monitor 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 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 StepTrack (wellness pedometer app, Class A):

"IEC 62304-1 Section 6.1 requires all software units to be verified."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304-1" which is incorrect. IEC 62304 is a single-part standard. The correct citation is IEC 62304:2006+AMD1:2015. 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 PillRemind (medication reminder app, Class A):

"The PillRemind risk analysis per ISO 14971:2019 identifies software items that could contribute to hazardous situations per IEC 62304 Clause 7.1.1. Each identified cause is documented per Clause 7.1.4. Risk control measures are defined per Clause 7.2.1 and traced to software requirements."

[Assistant]
Verdict: PASS
Note: Content correctly references ISO 14971:2019; risk management content follows ISO 14971 framework. 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-SAFE-001: "fail-safe behavior specification" (Category: safety)
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: A deterministic safe-state transition shall be triggered by any detected critical fault condition in the RetinaScan Diabetic Retinopathy Screener, with all active outputs brought to a known safe configuration.
Rationale: A deterministic safe-state transition prevents the Retinal Screening Software from operating in an unknown or hazardous state after a detected fault.
Priority: Mandatory
Acceptance Criterion: Safe state transition completes within the specified time limit for each defined critical fault, verified by fault injection during operation.
Source: Risk 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-PERF-002: "resource utilization limits" (Category: performance)
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 operate within the specified RAM and flash memory budget on the Web SPA platform, including all runtime allocations.
Rationale: Exceeding memory limits could cause undefined behavior in the Renal Dose Adjustment Calculator, potentially affecting safety.
Priority: Mandatory
Acceptance Criterion: Memory profiling under stress conditions shows stable allocation with no leaks over a 72-hour test period.
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 PillRemind (medication reminder app, Class A):

"Per IEC 62304 Clause 5.7, system testing is performed. Per IEC 62304 Clause 5.7, the system is tested. Per IEC 62304 Clause 5.7, system-level verification is conducted. Per IEC 62304 Clause 5.7, the PillRemind undergoes system testing."

[Assistant]
Verdict: FAIL
Note: The documentation section exhibits repeated clause prefix. Multiple sentences begin with the same clause reference. Each sentence restates the same concept without adding information. 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 SRS section on data retention and integrity requirements for TransVent Transport Ventilator, a Class C Transport Ventilator Firmware. Reference IEC 62304 Clause 5.2.2.
Portable transport ventilator firmware for ambulance and helicopter use. Must maintain ventilation under vibration and altitude changes.

[Assistant] Content: Data requirements for the TransVent Transport Ventilator specify retention periods, storage formats, and integrity controls for all persistent data managed by the Transport Ventilator Firmware. Data integrity is ensured through checksums or cryptographic hashes, and corrupted data is detected before use in any processing function.


[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 DialysisGuard (hemodialysis machine controller, Class C):

"All verification for the hemodialysis machine controller follows IEC 62311-1 requirements."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62311-1" which is incorrect. IEC 62311 covers EMF exposure limits, not medical device software. 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 RadView DICOM (DICOM image viewer, Class A):

"Software safety classification is performed per ISO 13485-2 Clause 4.3."

[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 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):

"The BloodBank Manager software development conforms to ISO 62304, with risk management per ISO 14971:2019."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 62304" which is incorrect. Wrong prefix. The correct standard is IEC 62304, not ISO 62304. 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 VentAssist Pro (ICU ventilator controller, Class C):

"Software release criteria for the VentAssist Pro include completeness of all Class C 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 full Class C rigor. 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 SRS section on latency and throughput requirements for SupplyChain Procurement Portal, a Class A Supply Chain Procurement System. Reference IEC 62304 Clause 5.2.2.
Web portal for ordering medical supplies with approval workflows. Procurement and logistics only.

[Assistant] Content: Performance requirements for the SupplyChain Procurement Portal specify maximum latencies, throughput rates, and resource consumption limits for the Supply Chain Procurement System operating on Web SPA. Latency requirements define the maximum time from input event to output response for each critical processing path during Managing procurement of medical supplies with approval tracking.


[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 risk control measures and implementation for BillingBridge Claims Processor, a Class A Claims Processing Service. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Backend service processing insurance claims from the hospital billing system. Financial processing only, no clinical data.

[Assistant] Content: Risk control measures for the BillingBridge Claims Processor are defined per Clause 7.2.1 and implemented in software per Clause 7.2.2. Controls include input validation for data inputs, range checking on processed values, and timeout detection on X12 EDI. Each control is traced to a software requirement and verified through testing.


[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 risk management integration into the lifecycle for FallRisk Inpatient Assessment Tool, a Class B Fall Risk Assessment App. Reference IEC 62304 Clauses 7.1, 7.1.1.
Web app calculating fall risk scores for inpatients based on mobility, medication, and cognitive assessments.

[Assistant] Content: The FallRisk Inpatient Assessment Tool risk management process is concurrent with development, not sequential. Software causes of hazardous situations are identified per Clause 7.1 and documented per Clause 7.1.4. Risk controls are implemented as software requirements and verified through the applicable testing levels for the Fall Risk Assessment App.


[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 ThermoGuard (body temperature logger, Class A):

"REQ-SRS-023: The ThermoGuard shall validate all input data against defined ranges before processing. Out-of-range values shall be rejected with an error code. Acceptance criterion: submit boundary values and verify correct acceptance/rejection. Priority: Mandatory. Source: Risk control."

[Assistant]
Verdict: PASS
Note: Content requirement is properly structured with measurable acceptance criteria; risk management content follows ISO 14971 framework. 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 FMEA section on failure mode identification approach for GlucoSpot Continuous Glucose Display, a Class B CGM Display App. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Mobile app receiving and displaying continuous glucose monitor readings via BLE. Shows trends, time-in-range, and configurable glucose alerts.

[Assistant] Content: Failure modes for each GlucoSpot Continuous Glucose Display software function are identified by systematic analysis of data flow paths, processing algorithms, and interface transactions. For each function, the analysis considers: incorrect output, missing output, output at wrong time, and unexpected output. Causes include coding defects, resource exhaustion, race conditions, and corrupted input from external sources.


[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 retention period" (Category: data)
Project: FridgeGuard Temperature Logger | Cold Chain Temperature Logger | Class A
Continuous logging and display of storage temperatures for compliance documentation. Firmware logging refrigerator temperatures for vaccine and medication cold chain compliance. Records and displays data, no alerts that drive clinical decisions.

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 Cold Chain Temperature Logger shall be maintained for the configured retention period before eligible for overwrite.
Rationale: Data retention supports clinical trend analysis and regulatory requirements for record keeping associated with the Cold Chain Temperature Logger.
Priority: Mandatory
Acceptance Criterion: Oldest data record remains retrievable after continuous operation for the specified retention period.
Source: Regulatory


[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 operational context and user population for SeismicWatch Earthquake Early Warning, a Class A Seismic Early Warning Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware for a network of MEMS accelerometers providing earthquake early warning by detecting P-waves and estimating magnitude.

[Assistant] Content: Operational context: the SeismicWatch Earthquake Early Warning is a Seismic Early Warning Firmware used for Detecting seismic P-waves and providing early warning of potentially damaging earthquakes. The software executes on Zynq-7000 SoC (FPGA + ARM) and interfaces with ADXL355 3-axis MEMS accelerometer (low noise) for data acquisition. The user population and use environment define the requirements for usability, reliability, and performance.


[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 operational context and user population 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: This section describes the operational context of the LinacControl Beam Delivery System Linear Accelerator Control Software. The system is intended for Controlling radiation beam delivery including gantry position, collimator settings, and dose monitoring, operating on VxWorks RTOS on PowerPC. Key interfaces include real-time fieldbus, safety PLC interface, operator console. These contextual factors drive the functional and non-functional requirements specified in subsequent sections.


[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):

"Standards compliance for the PillRemind medication reminder app is established through IEC 62304:2006+AMD1:2015 (Clauses 5, 7, 8, 9), ISO 14971:2019 (all clauses), and ISO 13485:2016 (Clause 7.3 design controls). All citations reference the current editions."

[Assistant]
Verdict: PASS
Note: Content uses the correct IEC 62304 citation; correctly references ISO 14971:2019; correctly references ISO 13485:2016. 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 risk control verification and traceability for PostureGuard Desk Monitor, a Class A Posture Wellness Display Software. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
USB webcam software that estimates sitting posture and displays a wellness score. No ergonomic prescriptions or clinical assessments.

[Assistant] Content: Verification of risk controls for the PostureGuard Desk Monitor follows Clause 7.3.1. Each control implemented in software has a corresponding test case that demonstrates the hazardous condition is mitigated. Traceability records per Clause 7.3.2 document the chain from hazard through requirement to verification evidence.


[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 MedInventory (medical supply tracking system, Class A):

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

[Assistant]
Verdict: FAIL
Note: The documentation section exhibits repeated project name. The project name 'MedInventory' appears excessively. Sentences repeat the same assertion about the medical supply tracking system in different words. Content should be consolidated and each sentence should contribute unique, specific information about the MedInventory.


[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 purpose and scope for Class B with moderate documentation for GlucoEdge Continuous Glucose Platform, a Class B Hybrid CGM Edge-Cloud Platform. Reference IEC 62304 Clause 5.1.1.
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.

[Assistant] Content: This plan establishes the development framework for the GlucoEdge Continuous Glucose Platform Hybrid CGM Edge-Cloud Platform, scoped to the Class B activities mandated by IEC 62304. Integration testing per Clause 5.6 and system testing per Clause 5.7 constitute the primary verification gates. Unit testing is recommended for safety-relevant modules but is not a mandatory deliverable at this classification level.


[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 system test execution and acceptance for Class A for GasMonitor Anesthetic Gas Logger, a Class A Anesthetic Gas Concentration Logger. Reference IEC 62304 Clauses 5.7, 5.7.4.
Software logging waste anesthetic gas concentrations in operating rooms for occupational safety compliance. Recording only.

[Assistant] Content: Acceptance of the GasMonitor Anesthetic Gas Logger is based solely on system test results per Clause 5.7. The test report documents pass/fail status for every requirement-derived test case, any anomalies discovered, and their disposition. Verification completeness per Clause 5.7.4 is demonstrated by the traceability matrix showing full requirements coverage. No unit or integration test results are required for this Class A Anesthetic Gas Concentration Logger.


[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 RadOnco Cloud Treatment Planner, a Class C Cloud Radiation Treatment Planning SaMD. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Cloud-based radiation oncology treatment planning system using GPU clusters for Monte Carlo dose calculation. Treatment plans directly drive linear accelerator delivery.

[Assistant] Content: The RadOnco Cloud Treatment Planner SRS follows a structured format: each requirement has a unique ID, a type classification, a priority, a rationale, and acceptance criteria per Clause 5.2.2. Requirements implementing risk control measures per Clause 5.2.3 are explicitly marked to ensure they receive verification attention proportional to their safety significance.


[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):

"The ChemoCalc development team follows appropriate processes and procedures. Training is provided as needed to ensure competency in relevant areas."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as needed" provide no project-specific information about the ChemoCalc chemotherapy dose calculator. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


[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: "user-configurable operating parameters" (Category: functional)
Project: WaveReview EEG Archive Viewer | EEG Archive Viewer | Class A
Read-only playback and display of archived EEG recordings. Desktop application for reviewing archived EEG recordings. Playback and waveform display only, no seizure detection.

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 EEG Archive Viewer shall be user-configurable within validated ranges and stored in non-volatile memory.
Rationale: Configurable parameters allow the EEG Archive Viewer 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 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 purpose and scope for Class C with full documentation for HomeVent BiPAP Controller, a Class C BiPAP Device Firmware. Reference IEC 62304 Clause 5.1.1.
Home bilevel positive airway pressure device firmware. Manages inspiratory/expiratory pressure, leak compensation, and patient triggering.

[Assistant] Content: All IEC 62304 development activities are in scope for the HomeVent BiPAP Controller, reflecting its Class C classification. The BiPAP Device Firmware processes flow sensor for Home bilevel ventilatory support with auto-titrating pressure and leak compensation, and failure could contribute to serious injury. This plan requires detailed design, unit verification with coverage targets, integration testing, system testing, and independent review by personnel not involved in the development 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-005: "configuration persistence and validation" (Category: functional)
Project: ConveyorGuard Safety Interlock System | Conveyor Safety Interlock Software | Class A
Monitoring safety interlocks and emergency stops on industrial conveyor systems. Safety PLC program monitoring conveyor belt guard positions, emergency stops, and light curtains. Functional safety application.

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 ConveyorGuard Safety Interlock System shall be validated against allowed ranges before acceptance and persisted to survive power loss.
Rationale: Configurable parameters allow the Conveyor Safety Interlock Software to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: All configurable parameters persist correctly across power cycles and reject out-of-range values with appropriate error messages.
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 THREAT section on threat model data flow decomposition for RenalDose Renal Adjustment Calculator, a Class B Renal Dose Adjustment Calculator. Reference IEC 62304 Clause 5.2.2.
Calculator adjusting medication doses for patients with impaired renal function based on eGFR.

[Assistant] Content: The RenalDose Renal Adjustment Calculator data flow diagrams for threat analysis map all data movement within and across the Renal Dose Adjustment Calculator boundary. Trust boundaries are placed at external interfaces (manual input, lab results API), persistent storage, and inter-process communication points.


[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 error propagation and data integrity in the pipeline for DoseVerify In-Vivo Dosimetry System, a Class C In-Vivo Dosimetry Verification Software. Reference IEC 62304 Clause 5.3.2.
Software calculating real-time delivered dose from in-vivo dosimeter readings during radiation therapy. Dose verification for patient safety.

[Assistant] Content: The DoseVerify In-Vivo Dosimetry System architecture defines error propagation rules at each interface per Clause 5.3.2. Invalid data from MOSFET dosimeters is detected at the acquisition boundary and does not propagate into processing stages. Each software item validates its inputs and reports errors through a defined error channel in the In-Vivo Dosimetry Verification Software.


[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-001: "stored data corruption detection" (Category: data)
Project: BreathSync ICU Ventilator Controller | ICU Ventilator Controller Software | Class C
Automated mechanical ventilation with multiple modes, alarm management, and patient synchronization. Software controlling an ICU mechanical ventilator with multiple ventilation modes (volume, pressure, SIMV). Failure could result in patient death.

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 ICU Ventilator Controller Software 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 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 WeatherNode Microclimate Station, a Class A Weather Station Firmware. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Solar-powered weather station firmware measuring temperature, humidity, wind, rainfall, and barometric pressure.

[Assistant] Content: Risk control coverage analysis for the WeatherNode Microclimate Station per Clause 7.3.2 confirms that every software-implemented risk control has a linked verification result demonstrating its effectiveness. Any risk control without verification evidence is treated as a critical gap blocking release of the Weather Station Firmware.


[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 VitalBoard Patient Summary, a Class A Patient Summary Dashboard. Reference IEC 62304 Clauses 8.2, 8.2.1.
Dashboard displaying patient vital signs history retrieved from the EMR. View-only with no alerting or trend analysis.

[Assistant] Content: Change control for the VitalBoard Patient Summary Patient Summary Dashboard 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 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on SOUP identification and management for SleepScore Apnea Screening Tool, a Class B Sleep Apnea Screening App. Reference IEC 62304 Clause 8.1.2.
Mobile app analyzing overnight audio recordings to screen for obstructive sleep apnea indicators. Screening only, not diagnostic.

[Assistant] Content: Identification of SOUP for the SleepScore Apnea Screening Tool follows Clause 8.1.2. Each SOUP component record includes title, version, supplier, intended function within the Sleep Apnea Screening App, and a reference to the anomaly evaluation performed per Clause 7.1.3. SOUP updates are managed through the change control process per Clause 8.2.


[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 data retention and integrity requirements for WeightAlert Neonatal Scale, a Class B Neonatal Scale Firmware. Reference IEC 62304 Clause 5.2.2.
Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

[Assistant] Content: Data requirements for the WeightAlert Neonatal Scale specify retention periods, storage formats, and integrity controls for all persistent data managed by the Neonatal Scale Firmware. Data integrity is ensured through checksums or cryptographic hashes, and corrupted data is detected before use in any processing function.


[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: "memory usage budget" (Category: performance)
Project: ClinTrial EDC Platform | Clinical Trial EDC Web Platform | Class A
Electronic capture and management of clinical trial data across multiple investigator sites. Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

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 ClinTrial EDC Platform memory footprint on AWS ECS + RDS PostgreSQL + S3 shall remain within specified limits under worst-case operational scenarios.
Rationale: Exceeding memory limits could cause undefined behavior in the Clinical Trial EDC Web Platform, 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 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 traceability scope including risk controls for PulseRing Smart Ring Monitor, a Class B Wearable Smart Ring Firmware + Companion App. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Wearable smart ring firmware measuring continuous PPG for heart rate and SpO2 with BLE streaming to companion mobile app for trend display.

[Assistant] Content: Traceability for the PulseRing Smart Ring Monitor Wearable Smart Ring Firmware + Companion App covers all software requirements per Clause 5.7.1 and all software-implemented risk controls per Clause 7.3.2. The combined matrix provides a single view of verification completeness for functional and safety aspects.


[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 threat categories applied to the device for AIDose Chemotherapy Decision Support, a Class C Cloud AI Chemotherapy Dosing SaMD. Reference IEC 62304 Clause 5.2.2.
Cloud SaMD providing AI-driven chemotherapy dosing recommendations based on patient genomics, lab values, and treatment response data.

[Assistant] Content: STRIDE threat analysis for the AIDose Chemotherapy Decision Support identifies specific threats at each data flow crossing a trust boundary. For the HL7 FHIR R4 interface: Spoofing is addressed by authentication, Tampering by integrity checks, Information Disclosure by encryption, and Denial of Service by rate limiting and timeout detection.


[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] Is IEC 62304:2022 a valid standard reference?

[Assistant] No. There is no 2022 edition of IEC 62304. The current edition is IEC 62304:2006+AMD1:2015.


[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 VibeCheck Vibration Analyzer, a Class A Vibration Analysis Instrument Firmware. Reference IEC 62304 Clause 5.2.2.
Portable vibration analysis firmware for predictive maintenance of industrial rotating machinery. FFT analysis of accelerometer data.

[Assistant] Content: User interaction requirements for the VibeCheck Vibration Analyzer define the input mechanisms, display elements, and feedback provided by the Vibration Analysis Instrument Firmware during Vibration spectrum analysis of industrial machinery for predictive maintenance. Requirements specify the information presented to the user, the actions available, and the system response to each user action.


[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 user interaction requirements for CogniTest Cognitive Assessment App, a Class B Cognitive Assessment Application. Reference IEC 62304 Clause 5.2.2.
Tablet app administering standardized cognitive screening tests and scoring results. Used by neuropsychologists in clinical settings.

[Assistant] Content: User interaction requirements for the CogniTest Cognitive Assessment App define the input mechanisms, display elements, and feedback provided by the Cognitive Assessment Application during Administering and scoring standardized cognitive screening tests for clinical neuropsychological assessment. Requirements specify the information presented to the user, the actions available, and the system response to each user action.


[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 WeightAlert Neonatal Scale, a Class B Neonatal Scale Firmware. Reference IEC 62304 Clause 5.2.1.
Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

[Assistant] Content: The WeightAlert Neonatal Scale threat model system description per IEC 81001-5-1:2021 identifies the Neonatal Scale Firmware as the subject, with trust boundaries at each external interface. Assets include software integrity, data confidentiality, and service availability during Precision weight measurement for neonatal patients with change-rate alerting.


[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 CaloriePal (nutrition tracking app, Class A):

"Software development follows IEC 62304 Clause Annex B.3 requirements for data archival."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause Annex B.3 which does not exist. IEC 62304 annexes are not cited as requirements. The reference must be corrected to a valid clause number.


[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):

"Compliance with IEC 62304 Clause 6.4 is demonstrated through automated regression testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 6.4 which does not exist. Clause 6 has 6.1, 6.2, 6.3 only. The reference must be corrected to a valid clause number.


[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 FetalGuard Heart Rate Monitor, a Class B Fetal Heart Rate Monitor Firmware. Reference IEC 62304 Clause 5.1.2.
External fetal heart rate monitor firmware using Doppler ultrasound. Displays fetal heart rate and variability during labor.

[Assistant] Content: The FetalGuard Heart Rate Monitor development lifecycle is governed by IEC 62304:2006+AMD1:2015. Risk management follows ISO 14971:2019. The quality management system underpinning all activities conforms to ISO 13485:2016. Usability engineering for the Fetal Heart Rate Monitor Firmware interface adheres to IEC 62366-1:2015+AMD1:2020.


[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 StepSync Activity Tracker, a Class A Wellness Activity Display App. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Mobile app displaying daily step count, distance, and calories from a wrist-worn accelerometer. Read-only display with no clinical interpretation.

[Assistant] Content: Requirements for the StepSync Activity Tracker Wellness Activity Display App are documented per Clause 5.2.2 with clear acceptance criteria enabling direct derivation of test cases. Each requirement traces backward to its source and forward to its verification activity in the traceability matrix.


[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):

"Referenced standards for the NurseCall Hub include IEC 62304:2006+AMD1:2015 (software lifecycle), ISO 14971:2019 (risk management), and ISO 13485:2016 (QMS). IEC 81001-5-1:2021 is referenced for cybersecurity considerations."

[Assistant]
Verdict: PASS
Note: Content uses the correct IEC 62304 citation; correctly references ISO 14971:2019; correctly references ISO 13485:2016. 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 risk control verification and traceability for BeamPlan Radiation Treatment Planner, a Class C Radiation Treatment Planning Software. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Desktop software calculating radiation treatment plans including beam angles, dose distribution, and organ-at-risk constraints.

[Assistant] Content: Risk control verification for the BeamPlan Radiation Treatment Planner per Clause 7.3.1 is performed as part of the applicable testing levels. Each risk control measure is traced per Clause 7.3.2 from the ISO 14971 risk analysis through the SRS to the test result confirming its implementation in the Radiation Treatment Planning Software.


[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 risk control requirements traceability for SunGuard UV Index Display, a Class A UV Exposure Display Firmware. Reference IEC 62304 Clause 5.2.3.
Wearable UV index monitor with an OLED display showing current UV exposure level. Informational only, no sunburn prevention claims.

[Assistant] Content: Software-implemented risk controls for the SunGuard UV Index Display 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 UV Exposure Display Firmware.


[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-003: "RAM and storage constraints" (Category: performance)
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: The WeightAlert Neonatal Scale memory footprint on MSP430 shall remain within specified limits under worst-case operational scenarios.
Rationale: Memory constraints are fixed by the MSP430 hardware and must be respected to prevent resource exhaustion during operation.
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 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):

"The VentAssist Pro software development conforms to IEC 62311-1, with risk management per ISO 14971:2019."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62311-1" which is incorrect. IEC 62311 covers EMF exposure limits, not medical device software. 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 SRS section on baseline security requirements for PainRelief PCA Pump Controller, a Class C PCA Pump Controller Firmware. Reference IEC 62304 Clause 5.2.2.
Patient-controlled analgesia pump firmware allowing patient-initiated doses within physician-set limits. Overdose prevention is safety-critical.

[Assistant] Content: Security requirements for the PainRelief PCA Pump Controller address authentication, data protection, and access control for the PCA Pump Controller Firmware. All persistent data is encrypted at rest, and data in transit over LCD uses transport layer encryption. Security requirements are aligned with IEC 81001-5-1:2021.


[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 verification and traceability for WaterPure Quality Logger, a Class A Water Quality Data Logger. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Embedded system logging purified water system parameters (conductivity, TOC, flow rate) for pharmaceutical manufacturing compliance.

[Assistant] Content: The WaterPure Quality Logger risk control traceability matrix per Clause 7.3.2 links every identified hazard cause to its software-implemented control and to the verification activity confirming its effectiveness. Clause 7.3.3 requires documentation of the verification results for each risk control measure applied to the Water Quality Data Logger.


[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 risk evaluation and anomaly management for TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

[Assistant] Content: The TriageAI Emergency Triage Assistant SOUP risk assessment per Clause 7.1.3 documents all known SOUP defects relevant to the ED Triage Decision Support App operational context. Where a SOUP defect could contribute to a hazardous situation, the architecture implements a software-level mitigation or the affected SOUP component is replaced.


[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 FactoryTemp Industrial Temperature Monitor, a Class A Industrial Temperature Monitoring Firmware. Reference IEC 62304 Clause 5.7.1.
Firmware monitoring factory floor temperatures from distributed thermocouple arrays. Logs data for process control compliance.

[Assistant] Content: The purpose of this traceability matrix is to confirm complete coverage of the FactoryTemp Industrial 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 Industrial Temperature Monitoring Firmware.


[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):

"Hazard analysis for the ChemoCalc identifies that incorrect display of measurement values could mislead the clinician. Risk control measures include input validation (REQ-SRS-023), display range checking, and a visual indicator when data is stale. Residual risk is acceptable per the risk management plan."

[Assistant]
Verdict: PASS
Note: Content requirement is properly structured with measurable acceptance criteria; 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 SDP section on safety classification process and documentation for VisitorPass Access Management, a Class A Visitor Management System. Reference IEC 62304 Clause 4.3.
Kiosk application for visitor registration and badge printing in hospital lobbies. Administrative access control.

[Assistant] Content: The VisitorPass Access Management safety classification is a prerequisite for determining the scope of IEC 62304 lifecycle activities. The classification was performed per Clause 4.3 using hazard analysis inputs from the ISO 14971 risk management process. Changes to the Visitor Management System intended use or risk profile trigger reclassification.


[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 data paths and processing pipeline for ECGInsight Rhythm Interpreter, a Class B ECG Interpretation Service. Reference IEC 62304 Clauses 5.3.1, 5.3.2.
Cloud service analyzing 12-lead ECG recordings and generating preliminary rhythm interpretations for physician review.

[Assistant] Content: The processing pipeline of the ECGInsight Rhythm Interpreter consists of sequential data transformations from raw input through processed output. Interface contracts per Clause 5.3.2 define the data format, timing, and error conditions at each pipeline stage boundary. The ECG Interpretation Service architecture supports both streaming and batch processing modes where 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 process for ChemoFlow Infusion Controller, a Class C Chemotherapy Infusion Pump Firmware. Reference IEC 62304 Clauses 8.2, 8.2.1.
Firmware for a chemotherapy infusion pump controlling precise drug delivery rates. Dosing errors could be life-threatening.

[Assistant] Content: The change control procedure for the ChemoFlow Infusion Controller mandates that every modification to a controlled configuration item is initiated via a change request per Clause 8.2.1. Each request documents the proposed change, safety impact assessment, affected configuration items, and required re-verification for the Chemotherapy Infusion 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 LabView Portal (read-only lab results viewer, Class A):

"IEC 62304 Clause 5.4.5 requires the LabView Portal to implement security testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.4.5 which does not exist. Clause 5.4 has 5.4.1 through 5.4.4 only. The reference must be corrected to a valid clause number.


[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 PharmaSafe CDSS, a Class B Clinical Decision Support System. Reference IEC 62304 Clause 5.2.2.
Clinical decision support system integrated into hospital EMR providing real-time drug-drug interaction alerts, allergy checking, and dosing guidance.

[Assistant] Content: Data flow decomposition for the PharmaSafe CDSS threat model identifies all pathways where data crosses trust boundaries in the Clinical Decision Support System. Each crossing point -- input from external sensors, output to display systems, and communication with remote services via REST API -- is analyzed for security threats.


[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 PressoTrack Blood Pressure Trending, a Class B Ambulatory Blood Pressure Monitor Firmware. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Firmware for an automated blood pressure cuff that trends readings over 24 hours. Trending errors could mask hypertensive episodes.

[Assistant] Content: The failure mode identification for the PressoTrack Blood Pressure Trending Ambulatory Blood Pressure Monitor 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 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 PharmaSafe CDSS, a Class B Clinical Decision Support System. Reference IEC 62304 Clause 5.2.2.
Clinical decision support system integrated into hospital EMR providing real-time drug-drug interaction alerts, allergy checking, and dosing guidance.

[Assistant] Content: Requirements for external system integration with the PharmaSafe CDSS specify the API contracts, data formats, and error handling behavior for all outbound communication from the Clinical Decision Support System. The software must handle connection timeouts, malformed responses, and authentication failures without affecting safety-relevant functions.


[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 FetaSound (fetal heart rate monitor, Class B):

"REQ-SRS-067: The FetaSound shall enforce role-based access control with at least two privilege levels (operator and administrator). Acceptance criterion: verify that operator accounts cannot access administrator functions. Priority: Mandatory. Source: Regulatory."

[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 PhysioTrack Rehab (rehabilitation tracking system, Class B):

"IEC 62304 Clause 5.4.5 requires the PhysioTrack Rehab to implement detailed design verification."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.4.5 which does not exist. Clause 5.4 has 5.4.1 through 5.4.4 only. The reference must be corrected to a valid clause number.


[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 VitalPulse SpO2 Monitor, a Class B Pulse Oximeter Firmware. Reference IEC 62304 Clause 5.1.2.
Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

[Assistant] Content: Applicable standards for the VitalPulse SpO2 Monitor 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 Pulse Oximeter Firmware.


[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 cybersecurity and health IT standards for TrainCert Staff Certification Tracker, a Class A Training Certification System. Reference IEC 62304 Clause 5.1.2.
Web app tracking staff training certifications and renewal dates. Administrative HR tool for compliance tracking.

[Assistant] Content: The TrainCert Staff Certification Tracker cybersecurity posture is defined per IEC 81001-5-1:2021, covering threat modeling, secure design, vulnerability management, and incident response for the Training Certification System. Health software product safety requirements from IEC 82304-1:2016 supplement the IEC 62304 lifecycle where applicable.