[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 DoseVerify In-Vivo Dosimetry System, a Class C In-Vivo Dosimetry Verification Software. Reference IEC 62304 Clause 5.2.1.
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 threat model scope encompasses the In-Vivo Dosimetry Verification Software, its communication interfaces (electrometer readout, DICOM RT plan comparison, alarm output), stored data, and the operational environment. Data flows between the MOSFET dosimeters and the application logic, and between the application and alarm output are analyzed for potential security threats.


[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):

"Software problem resolution follows ISO 14971:2020 Clause 9."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 14971:2020" which is incorrect. No 2020 edition. Current: ISO 14971:2019. 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 HydroLog (hydration tracking wellness app, Class A):

"Per Clause 5.4.2, each software unit of the HydroLog has detailed design documentation."

[Assistant]
Verdict: FAIL
Note: Content mandates detailed design documentation for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Detailed design (Clause 5.4) is required only for Class C.


[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 RetinaStim Visual Prosthesis Controller, a Class C Retinal Prosthesis Controller Firmware. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Firmware driving a retinal implant electrode array based on camera input processing. Stimulation errors could cause retinal damage.

[Assistant] Content: The RetinaStim Visual Prosthesis Controller risk controls per Clause 7.2.1 address each failure mode with unacceptable residual risk. Software-implemented controls per Clause 7.2.2 include defensive coding measures, plausibility checks, and safe-state transitions. Each control is documented as a software requirement and verified for the Retinal Prosthesis Controller Firmware.


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

[User]
Write a SRS section on purpose of the SRS document for MindCalm Meditation Timer, a Class A Meditation Wellness App. Reference IEC 62304 Clause 5.2.1.
Mobile app providing guided meditation timers with optional heart rate display during sessions. Heart rate shown for interest only, not diagnostic.

[Assistant] Content: This document specifies the software requirements for the MindCalm Meditation Timer Meditation Wellness App as required by IEC 62304 Clause 5.2.1. It serves as the primary input to design and the primary reference for verification test case derivation. All requirements are verifiable, traceable, and configuration-controlled.


[System] You are 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):

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

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


[System] You are a regulatory 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):

"IEC 14971 Section 4.3 requires all software units to be verified."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 14971" which is incorrect. Wrong prefix. The correct standard is ISO 14971, not IEC 14971. 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 SRS section on system boundaries and external dependencies for CleanRoom Particle Counter Logger, a Class A Cleanroom Environmental Logger. Reference IEC 62304 Clause 5.2.2.
Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

[Assistant] Content: System boundaries for the CleanRoom Particle Counter Logger are defined at the software interface level. The Cleanroom Environmental Logger receives input from optical particle counter and produces output via RS-485 Modbus. Components beyond these interfaces are outside the scope of this SRS and are addressed in system-level documentation.


[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 documenting failure modes and their effects for AquaGuard Water Quality Monitor, a Class A Water Quality Monitoring Firmware. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Firmware for a multi-parameter water quality probe measuring pH, dissolved oxygen, conductivity, and turbidity in rivers and lakes.

[Assistant] Content: Documentation of AquaGuard Water Quality Monitor failure modes follows Clause 7.1.4. Each entry in the FMEA register includes: the software item, the failure mode, the potential cause(s), the effect on the Water Quality Monitoring Firmware during In-situ measurement of water quality parameters for environmental monitoring, severity and probability ratings, and references to applicable risk control measures.


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

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

"The development plan references IEC 62304 Clause 10.1 and Clause 5.0 for the BloodBank Manager."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 10.1 and 5.0, neither of which exists. IEC 62304 has no Clause 10. Standard ends at Clause 9. Clause 5 starts at 5.1. All clause 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 WoundTrack (wound measurement imaging system, Class B):

"The lifecycle processes for the WoundTrack comply with IEC 14971."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 14971" which is incorrect. Wrong prefix. The correct standard is ISO 14971, not IEC 14971. All references must be corrected.


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

[User]
Expand requirement SRS-FUNC-002: "real-time data presentation on HL7 FHIR AllergyIntolerance API" (Category: functional)
Project: AllergyCard Patient Allergy Viewer | Patient Allergy Display | Class A
Read-only display of patient allergy information at point of care. Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

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 AllergyCard Patient Allergy Viewer shall update the displayed values on the HL7 FHIR AllergyIntolerance API at intervals no greater than the specified refresh period.
Rationale: Display freshness is critical for the Patient Allergy Display to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: End-to-end latency from data acquisition to display update does not exceed the specified limit for 99.9% of samples.
Source: User need


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

[User]
Expand requirement SRS-INTF-001: "primary sensor communication specification" (Category: interface)
Project: PedDose Pediatric Dosing App | Pediatric Dosing Calculator App | Class B
Weight-based pediatric dose calculations with age-appropriate range checking. Mobile reference app for pediatric drug dosing with weight-based calculations and age-specific ranges.

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 Pediatric Dosing Calculator App sensor interface shall establish and maintain reliable communication with the primary sensor via local drug database.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Pediatric Dosing Calculator App output.
Priority: Mandatory
Acceptance Criterion: Error injection tests confirm 100% detection rate for corrupted frames and recovery within specified timeout.
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 EchoAssist (echocardiogram analysis aid, Class B):

"All verification for the echocardiogram analysis aid follows ISO 13485-1 requirements."

[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 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 DialysisGuard (hemodialysis machine controller, Class C):

"The DialysisGuard fault tree analysis identifies root causes of potential software failures. Control measures include watchdog timers, redundant calculations, and plausibility checks on sensor data. Each measure is a traceable software requirement verified during system testing."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the DialysisGuard (hemodialysis machine controller, Class C). 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 development methodology for Class A for LabStream LIS Middleware, a Class A Laboratory Information Middleware. Reference IEC 62304 Clause 5.1.1.
Middleware software connecting laboratory analyzers to the hospital LIS. Routes results, applies auto-validation rules, and flags critical values.

[Assistant] Content: The LabStream LIS Middleware follows an agile-inspired iterative lifecycle with lightweight phase gates suited to Class A software. Milestones are Requirements Baseline, Implementation Freeze, and System Test Complete. No architecture review or detailed design review gate is required, as these artifacts are not mandated for Class A.


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

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

"Risk management is performed. Risk analysis is conducted. Risk evaluation is completed. Risk control measures are implemented. Risk management activities are documented. The risk management process is followed."

[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 PhysioTrack Rehab.


[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 NeuroStim Programmer (neurostimulator programmer, Class C):

"The NeuroStim Programmer development follows IEC 62304:2006+AMD1:2015 for the software lifecycle. Risk management is performed per ISO 14971:2019. The quality management system conforms to ISO 13485:2016."

[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 configuration identification approach for ChestAI Pulmonary Nodule Detector, a Class B AI Pulmonary Nodule Detection SaMD. Reference IEC 62304 Clauses 8.1, 8.1.1.
Cloud AI SaMD analyzing chest CT scans to detect and measure pulmonary nodules, providing CAD overlay for radiologist review. FDA De Novo pathway.

[Assistant] Content: The configuration identification scheme for the ChestAI Pulmonary Nodule Detector assigns a unique identifier to every controlled artifact: source code modules, build configurations, documentation deliverables, and verification records. The scheme supports reconstruction of any released baseline of the AI Pulmonary Nodule Detection SaMD per Clause 8.1.1.


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

[User]
Write a SRS section on system boundaries and external dependencies for CardioLoop Cardiac Resync Controller, a Class C CRT Optimization Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware for cardiac resynchronization therapy devices optimizing biventricular pacing based on hemodynamic feedback.

[Assistant] Content: The CardioLoop Cardiac Resync Controller system overview identifies all external entities interacting with the CRT Optimization Firmware: input sources (intracardiac impedance), output destinations (programmer interface), and the Ultra-low-power ASIC + ARM Cortex-M0 execution environment. Requirements for each external interface are documented in the interface requirements section.


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

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

"IEC 62304 Clause 5.5.6 requires the HydroLog to implement user acceptance testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.5.6 which does not exist. Clause 5.5 has 5.5.1 through 5.5.5 only. 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 NurseCall Hub (patient call system dashboard, Class A):

"The NurseCall Hub test strategy is limited to system-level verification per Clause 5.7. Regression testing is performed when changes occur per Clause 5.7.3. Test record contents follow Clause 5.7.5. This is sufficient for Class A."

[Assistant]
Verdict: PASS
Note: Content correctly limits Class A to system-level verification; limits verification to system testing per Clause 5.7. 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 SDP section on requirements verification approach for HomeVent BiPAP Controller, a Class C BiPAP Device Firmware. Reference IEC 62304 Clause 5.2.6.
Home bilevel positive airway pressure device firmware. Manages inspiratory/expiratory pressure, leak compensation, and patient triggering.

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


[System] You are a 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: "resource utilization limits" (Category: performance)
Project: SeismicWatch Earthquake Early Warning | Seismic Early Warning Firmware | Class A
Detecting seismic P-waves and providing early warning of potentially damaging earthquakes. Firmware for a network of MEMS accelerometers providing earthquake early warning by detecting P-waves and estimating magnitude.

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 SeismicWatch Earthquake Early Warning shall operate within the specified RAM and flash memory budget on the Zynq-7000 SoC (FPGA + ARM) platform, including all runtime allocations.
Rationale: Memory constraints are fixed by the Zynq-7000 SoC (FPGA + ARM) 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 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):

"The VentAssist Pro problem resolution process follows Clause 9. Problem reports are prepared per Clause 9.1, investigated per Clause 9.2, and resolved through the change control process per Clause 9.4. Trends are analyzed per Clause 9.6."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the VentAssist Pro (ICU ventilator controller, Class C). 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 baseline security requirements for IncidentReport Clinical Event Logger, a Class A Incident Reporting System. Reference IEC 62304 Clause 5.2.2.
Web form for staff to submit clinical incident reports. Data entry and routing only, no analysis.

[Assistant] Content: The IncidentReport Clinical Event Logger security requirements cover confidentiality, integrity, and availability of the Incident Reporting System and its data per IEC 81001-5-1:2021. Requirements specify access control mechanisms, encryption for data at rest and in transit, session management, and audit logging.


[System] You are a 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: "continuous data sampling from camera barcode scanner" (Category: functional)
Project: WasteTrack Biohazard Logger | Biohazard Waste Tracking App | Class A
Logging and tracking biohazard waste container chain of custody. Mobile app scanning and logging biohazard waste container pickups. Tracks chain of custody for environmental compliance.

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

[Assistant]
Description: The WasteTrack Biohazard Logger software shall acquire camera barcode scanner data at the specified sampling rate and store values in a circular buffer for processing by the Biohazard Waste Tracking App signal pipeline.
Rationale: Continuous data acquisition from the primary sensor is the fundamental input for Logging and tracking biohazard waste container chain of custody.
Priority: Mandatory
Acceptance Criterion: Verified by test: software acquires sensor data continuously for 60 minutes without data loss, confirmed by comparing acquisition count against expected count at the configured sampling rate.
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 THREAT section on STRIDE threat categories applied to the device for FetalGuard Heart Rate Monitor, a Class B Fetal Heart Rate Monitor Firmware. Reference IEC 62304 Clause 5.2.2.
External fetal heart rate monitor firmware using Doppler ultrasound. Displays fetal heart rate and variability during labor.

[Assistant] Content: Threats to the FetalGuard Heart Rate Monitor are categorized using the STRIDE framework: Spoofing of analog signal conditioning identity, Tampering with sensor data or configuration, Repudiation of clinical actions, Information Disclosure of patient data, Denial of Service disrupting Continuous external fetal heart rate monitoring during labor with clinical display, and Elevation of Privilege through unauthorized parameter changes.


[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 system test execution and acceptance for Class A for FridgeGuard Temperature Logger, a Class A Cold Chain Temperature Logger. Reference IEC 62304 Clauses 5.7, 5.7.4.
Firmware logging refrigerator temperatures for vaccine and medication cold chain compliance. Records and displays data, no alerts that drive clinical decisions.

[Assistant] Content: System tests for the FridgeGuard Temperature Logger are executed on the ATmega328P target with the Cold Chain Temperature Logger operating in its intended configuration. Test results are recorded per Clause 5.7.5, and the system test is verified complete per Clause 5.7.4 when all requirements have a linked passing test. No unit tests or integration tests are produced, as Class A does not require these verification levels.


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

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

"The RetinaScan Pro addresses IEC 62304 Clause 10.1 for automated regression testing and Clause Annex A.1 for operational qualification."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 10.1 and Annex A.1, neither of which exists. IEC 62304 has no Clause 10. Standard ends at Clause 9. IEC 62304 annexes are informative, not cited as requirements. All clause 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 RetinaScan Pro (diabetic retinopathy screening AI, Class B):

"Traceability is maintained as needed between requirements, design, and test artifacts. Coverage is assessed at appropriate milestones throughout the lifecycle."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as needed", "appropriate milestones" provide no project-specific information about the RetinaScan Pro diabetic retinopathy screening AI. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


[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 change control and trend analysis for problems for BreathEasy Air Quality Display, a Class A Environmental Air Quality Display. Reference IEC 62304 Clauses 9.4, 9.6.
Indoor air quality monitor displaying PM2.5, CO2, and temperature on an LCD. Informational display only with no clinical guidance.

[Assistant] Content: Corrections to the BreathEasy Air Quality Display 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 Environmental Air Quality Display.


[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 RadBeam Planner (radiation therapy planning system, Class C):

"Software problem resolution follows IEC 62304:2020 Clause 9."

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


[System] You are 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 safety classification is performed per IEC 62304-1 Clause 4.3."

[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 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 PulmoCheck Spirometry Analyzer, a Class B Spirometry Analysis Software. Reference IEC 62304 Clauses 9.1, 9.2.
Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

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


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

[User]
Write a SDP section on milestones and phase transition criteria for ThermoWatch Core Temperature Monitor, a Class B Core Temperature Monitor Firmware. Reference IEC 62304 Clause 5.1.1.
Continuous core temperature monitoring firmware using an ingestible sensor pill. Displays temperature trend with configurable alerts.

[Assistant] Content: Phase transitions for the ThermoWatch Core Temperature Monitor are gated by documented completion criteria. The Requirements Baseline requires verified, traceable software requirements. The Implementation Freeze requires all code reviewed and committed. The Release Readiness Review requires all verification records complete, all problem reports dispositioned, and the Core Temperature Monitor Firmware release package assembled.


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

[User]
Write a TRACE section on purpose and scope of the traceability matrix for WaveReview EEG Archive Viewer, a Class A EEG Archive Viewer. Reference IEC 62304 Clause 5.7.1.
Desktop application for reviewing archived EEG recordings. Playback and waveform display only, no seizure detection.

[Assistant] Content: This traceability matrix demonstrates bidirectional traceability between requirements, design elements, and verification activities for the WaveReview EEG Archive Viewer per IEC 62304 Clause 5.7.1. Each software requirement is traced forward to the design element that implements it and to the test case that verifies it, ensuring complete coverage with no unlinked requirements or untested design elements.


[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 resource constraints and scalability for FallRisk Inpatient Assessment Tool, a Class B Fall Risk Assessment App. Reference IEC 62304 Clause 5.2.2.
Web app calculating fall risk scores for inpatients based on mobility, medication, and cognitive assessments.

[Assistant] Content: Resource requirements for the FallRisk Inpatient Assessment Tool specify maximum memory utilization, persistent storage consumption, and processor loading on Web SPA. The Fall Risk Assessment App must operate within these constraints under worst-case conditions without degradation of safety-relevant functions.


[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 RoomBoard Digital Signage, a Class A Patient Room Digital Signage. Reference IEC 62304 Clauses 8.1, 8.1.1.
Hospital room digital signage displaying patient name, care team, and daily schedule. Display-only, no clinical data entry.

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


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

[User]
Expand requirement SRS-INTF-002: "primary sensor communication specification" (Category: interface)
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: Communication with the primary sensor over REST API shall include CRC-based error detection, automatic retry, and graceful degradation on persistent failure.
Rationale: Reliable sensor communication is the foundation of the Clinical Trial EDC Web Platform data acquisition pipeline.
Priority: Mandatory
Acceptance Criterion: Error injection tests confirm 100% detection rate for corrupted frames and recovery within specified timeout.
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 CaloriePal (nutrition tracking app, Class A):

"Per IEC 62304, the CaloriePal software requirements are documented. Per IEC 62304, all requirements for the CaloriePal are captured. Per IEC 62304, the requirements are recorded in the SRS. Per IEC 62304, each requirement is traceable to its source."

[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 CaloriePal.


[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 InhaleSense Smart Inhaler Tracker, a Class A Smart Inhaler Adherence Tracker. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Firmware for a smart inhaler attachment detecting actuation events, tracking medication adherence, and syncing data to a mobile app and clinician portal.

[Assistant] Content: The InhaleSense Smart Inhaler Tracker traceability matrix extends beyond functional requirements to include risk control traceability per Clause 7.3.2. Each risk control measure implemented in the Smart Inhaler Adherence Tracker software is traced from the ISO 14971 hazard through the software requirement to the verification test confirming its effectiveness.


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

[User]
Expand requirement SRS-INTF-001: "primary sensor interface protocol" (Category: interface)
Project: PathSlide Digital Pathology Viewer | Digital Pathology Viewer | Class A
Display of digitized pathology slides for reference viewing. Web viewer for whole-slide digital pathology images. Pan, zoom, and annotation display. No AI-assisted diagnosis.

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: Communication with the primary sensor over REST API shall include CRC-based error detection, automatic retry, and graceful degradation on persistent failure.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Digital Pathology Viewer output.
Priority: Mandatory
Acceptance Criterion: Communication operates without data loss for 72 hours continuously, with automatic recovery from simulated failures within the specified time.
Source: System requirement


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

[User]
Expand requirement SRS-PERF-002: "resource utilization limits" (Category: performance)
Project: DermaAssist Skin Lesion Classifier | Skin Lesion Classification App | Class B
AI-assisted classification of skin lesion images as benign or suspicious for dermatologist review. Mobile app using a CNN to classify skin lesion images as benign/suspicious. Decision support requiring dermatologist confirmation.

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 DermaAssist Skin Lesion Classifier shall operate within the specified RAM and flash memory budget on the iOS + cloud GPU platform, including all runtime allocations.
Rationale: Memory constraints are fixed by the iOS + cloud GPU 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 LabView Portal (read-only lab results viewer, Class A):

"IEC 62304 Clause 5.1.12 requires the LabView Portal to implement performance benchmarking."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.1.12 which does not exist. Clause 5.1 has 5.1.1 through 5.1.11 only. The reference must be corrected to a valid clause number.


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

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

"The RetinaScan Pro architectural design identifies software items and their boundaries. Each interface is documented with data types, ranges, and error conditions. Segregation for risk control is identified per Clause 5.3.5. SOUP items are specified per Clause 5.3.3 and 5.3.4."

[Assistant]
Verdict: PASS
Note: Content 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 scope boundaries of the software system for AquaGuard Water Quality Monitor, a Class A Water Quality Monitoring Firmware. Reference IEC 62304 Clauses 5.1.1, 5.1.2.
Firmware for a multi-parameter water quality probe measuring pH, dissolved oxygen, conductivity, and turbidity in rivers and lakes.

[Assistant] Content: This plan applies to all software executing within the AquaGuard Water Quality Monitor Water Quality Monitoring Firmware and its supporting build and verification infrastructure. External systems that exchange data with the Water Quality Monitoring Firmware via SDI-12 are covered only at the interface boundary; their internal implementation is outside the scope of this SDP.


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

[User]
Write a SRS section on functional requirements overview for GrowthChart Pediatric Viewer, a Class A Growth Chart Display App. Reference IEC 62304 Clause 5.2.2.
Web app displaying pediatric growth charts with WHO/CDC percentile curves. Plots measurements, no diagnostic interpretation.

[Assistant] Content: The GrowthChart Pediatric Viewer functional requirements define what the Growth Chart Display App does in response to user inputs, sensor data, and system events. Requirements are organized by functional area: data acquisition, signal processing, display and output, and system management. Each requirement is individually testable.


[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 AutoDose TPN (total parenteral nutrition calculator, Class C):

"Architecture for the AutoDose TPN transforms requirements into a software architecture per Clause 5.3.1. Interfaces between software items are defined per Clause 5.3.2. SOUP functional requirements are specified per Clause 5.3.3. The architecture is verified per Clause 5.3.6."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the AutoDose TPN (total parenteral nutrition calculator, Class C). 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 VentAssist Pro (ICU ventilator controller, Class C):

"The VentAssist Pro development follows full Class C rigor: detailed design documentation, unit testing with coverage targets (statement 90%, branch 80%, MC/DC 80%), integration testing of all interfaces, system testing, and independent verification. All activities are traceable to requirements."

[Assistant]
Verdict: PASS
Note: Content correctly specifies full Class C rigor; correctly specifies independent review for Class C. 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 EchoAssist (echocardiogram analysis aid, Class B):

"The software architecture is designed following best engineering practices. Modules are structured to support maintainability and extensibility as needed."

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


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

[User]
Review this documentation excerpt for the ThermoGuard (body temperature logger, Class A):

"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 SRS section on enhanced security for Class B and C for BSACalc Body Surface Area Tool, a Class B BSA Calculator Web App. Reference IEC 62304 Clause 5.2.2.
Web calculator for body surface area using Mosteller and DuBois formulas. Used for chemotherapy dose calculations.

[Assistant] Content: The BSACalc Body Surface Area Tool BSA Calculator Web App implements security-in-depth: secure boot, runtime integrity monitoring, encrypted communications, and input validation on all external interfaces per IEC 81001-5-1:2021. Security testing covers penetration testing, fuzz testing of web form, and vulnerability scanning.


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

[User]
Expand requirement SRS-FUNC-002: "alarm threshold management" (Category: functional)
Project: RespiRate Respiratory Monitor | Respiratory Rate Monitor Firmware | Class B
Continuous respiratory rate monitoring with alarm generation for abnormal rates. Wearable firmware monitoring respiratory rate via chest impedance. Displays rate and alerts on bradypnea/tachypnea.

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 Respiratory Rate Monitor Firmware shall monitor all active parameters against user-configured thresholds and activate appropriate alarm signals when limits are breached.
Rationale: Alarm functionality is a safety-critical feature of the Respiratory Rate Monitor Firmware that directly supports clinical decision-making.
Priority: Mandatory
Acceptance Criterion: No alarm condition goes undetected across 200 simulated threshold exceedances with varying parameter values and crossing rates.
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 safety classification process and documentation for SurgLog Procedure Documentation App, a Class A Surgical Documentation App. Reference IEC 62304 Clause 4.3.
Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

[Assistant] Content: Software safety classification for the SurgLog Procedure Documentation App follows the procedure defined in IEC 62304 Clause 4.3. The classification considers whether the Surgical Documentation App can contribute to a hazardous situation and, if so, whether external risk controls reduce the severity to non-serious injury. The result directly determines which IEC 62304 lifecycle activities are mandatory.


[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 verification strategy for Class A -- system testing only for GrowthChart Pediatric Viewer, a Class A Growth Chart Display App. Reference IEC 62304 Clauses 5.7, 5.7.1.
Web app displaying pediatric growth charts with WHO/CDC percentile curves. Plots measurements, no diagnostic interpretation.

[Assistant] Content: The GrowthChart Pediatric Viewer verification strategy relies solely on system testing, consistent with Class A requirements under IEC 62304. Each software requirement maps to at least one system test case, validated against the Growth Chart Display App in its operational environment. No unit testing or integration testing is performed -- these activities are not mandated for Class A and would add unnecessary process overhead for the Growth Chart Display App.


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

[User]
Expand requirement SRS-FUNC-001: "alarm threshold management" (Category: functional)
Project: HomeVent BiPAP Controller | BiPAP Device Firmware | Class C
Home bilevel ventilatory support with auto-titrating pressure and leak compensation. Home bilevel positive airway pressure device firmware. Manages inspiratory/expiratory pressure, leak compensation, and patient triggering.

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

[Assistant]
Description: The BiPAP Device Firmware shall monitor all active parameters against user-configured thresholds and activate appropriate alarm signals when limits are breached.
Rationale: Alarm functionality is a safety-critical feature of the BiPAP Device Firmware that directly supports clinical decision-making.
Priority: Mandatory
Acceptance Criterion: No alarm condition goes undetected across 200 simulated threshold exceedances with varying parameter values and crossing rates.
Source: Risk control


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

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

"This plan is prepared in compliance with IEC 62304:2015 and ISO 13485:2016."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304:2015" which is incorrect. Wrong citation. Correct: IEC 62304:2006+AMD1:2015 (base standard from 2006, Amendment 1 in 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 LabView Portal (read-only lab results viewer, Class A):

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

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


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

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

"Referenced standards for the OxyPure Controller 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 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):

"Verification activities follow IEC 62304 Clause 5.5.2.1 for continuous monitoring."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.5.2.1 which does not exist. IEC 62304 has no four-level numbering. 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 HydroLog (hydration tracking wellness app, Class A):

"The HydroLog system testing addresses functional requirements, performance limits, and boundary conditions. As Class A software, no additional verification levels are mandated. Test anomalies are managed per the problem resolution process."

[Assistant]
Verdict: PASS
Note: Content correctly limits Class A to system-level verification. 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-FUNC-001: "configuration persistence and validation" (Category: functional)
Project: DermaLens Teledermatology Platform | Cloud Teledermatology SaMD | Class B
AI-assisted triage scoring of skin lesion images submitted through a mobile teledermatology workflow. Cloud platform enabling dermatologists to review patient-submitted skin images with AI-assisted triage scoring. Images uploaded from mobile app to cloud pipeline.

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 Cloud Teledermatology SaMD shall be user-configurable within validated ranges and stored in non-volatile memory.
Rationale: Configurable parameters allow the Cloud Teledermatology SaMD 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 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):

"The maintenance plan ensures continued compliance with applicable requirements. Updates are managed through established change control as appropriate."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as appropriate", "applicable requirements" provide no project-specific information about the DermaScan AI skin lesion classifier. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


[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 BalanceBoard Vestibular Trainer, a Class B Balance Training Platform Firmware. Reference IEC 62304 Clause 5.2.2.
Force plate firmware measuring center-of-pressure excursions during balance exercises. Provides real-time visual biofeedback.

[Assistant] Content: The BalanceBoard Vestibular Trainer operates as a Balance Training Platform Firmware where Measuring postural sway and providing visual biofeedback during vestibular rehabilitation. The software interfaces with 4x load cells and communicates via USB, Bluetooth. The operational environment, user population, and regulatory context described here constrain the requirements that follow.


[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 risk control verification for HandGrip Strength Dynamometer, a Class B Hand Dynamometer Firmware. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Digital hand dynamometer firmware measuring grip strength and fatigue over repeated trials for rehabilitation assessment.

[Assistant] Content: Verification of risk control measures for the HandGrip Strength Dynamometer follows Clause 7.3.1. Each software-implemented control is tested to demonstrate that the hazardous condition is mitigated to an acceptable level. Verification results per Clause 7.3.3 are documented in the risk management file for the Hand Dynamometer 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 requirements verification approach for DermaLens Teledermatology Platform, a Class B Cloud Teledermatology SaMD. Reference IEC 62304 Clause 5.2.6.
Cloud platform enabling dermatologists to review patient-submitted skin images with AI-assisted triage scoring. Images uploaded from mobile app to cloud pipeline.

[Assistant] Content: Verification of DermaLens Teledermatology Platform software requirements follows Clause 5.2.6. Reviewers confirm that every requirement is complete, consistent, testable, and traceable. Requirements that implement risk controls are additionally verified against the ISO 14971 risk management file for the Cloud Teledermatology SaMD.


[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 functional requirements overview for VitalPulse SpO2 Monitor, a Class B Pulse Oximeter Firmware. Reference IEC 62304 Clause 5.2.2.
Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

[Assistant] Content: The VitalPulse SpO2 Monitor functional requirements define what the Pulse Oximeter Firmware does in response to user inputs, sensor data, and system events. Requirements are organized by functional area: data acquisition, signal processing, display and output, and system management. Each requirement is individually testable.


[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 gap identification and coverage analysis for SupplyChain Procurement Portal, a Class A Supply Chain Procurement System. Reference IEC 62304 Clause 5.7.4.
Web portal for ordering medical supplies with approval workflows. Procurement and logistics only.

[Assistant] Content: The gap analysis for the SupplyChain Procurement Portal identifies any software requirements without linked test cases, design elements without source requirements (orphan implementations), and test cases that do not trace to any requirement (unnecessary tests). All gaps are documented and resolved before the Release Readiness Review to confirm that the Supply Chain Procurement System verification is complete per Clause 5.7.4.


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

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

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

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


[System] You are 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 DialysisGuard (hemodialysis machine controller, Class C):

"IEC 62304-4 Section 4.3 requires all software units to be verified."

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


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

[User]
Expand requirement SRS-INTF-002: "data export and interoperability" (Category: interface)
Project: GasMonitor Anesthetic Gas Logger | Anesthetic Gas Concentration Logger | Class A
Recording waste anesthetic gas levels for occupational safety documentation. Software logging waste anesthetic gas concentrations in operating rooms for occupational safety compliance. Recording only.

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 Anesthetic Gas Concentration Logger shall support bidirectional data exchange with external systems over RS-232.
Rationale: External system connectivity is required for the Anesthetic Gas Concentration Logger 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 AutoDose TPN (total parenteral nutrition calculator, Class C):

"The lifecycle processes for the AutoDose TPN comply with ISO 14901."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 14901" which is incorrect. ISO 14901 does not exist. The risk management standard is ISO 14971:2019. All references must be corrected.


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

[User]
Review this documentation excerpt for the ArthroNav (surgical navigation system, Class C):

"The ArthroNav SOUP risk evaluation examines published anomaly lists per Clause 7.1.3. Known anomalies in third-party libraries are assessed for potential contribution to hazardous situations. Mitigations include version pinning, input validation, and fallback behavior when SOUP components fail."

[Assistant]
Verdict: PASS
Note: Content 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 lightweight review process for Class A for GrowthChart Pediatric Viewer, a Class A Growth Chart Display App. Reference IEC 62304 Clause 5.1.1.
Web app displaying pediatric growth charts with WHO/CDC percentile curves. Plots measurements, no diagnostic interpretation.

[Assistant] Content: For the Class A GrowthChart Pediatric Viewer, deliverable reviews are conducted by the project lead, who confirms technical completeness, and the quality representative, who confirms process compliance. Reviews are documented with sign-off records. No independent reviewer external to the project team is mandated.


[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 tools and tool qualification for Class A for PharmLog Medication History Viewer, a Class A Medication History Viewer. Reference IEC 62304 Clause 5.1.4.
Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

[Assistant] Content: Development of the PharmLog Medication History Viewer uses Swift on iOS. Build automation ensures reproducible compilation, and all toolchain versions are recorded as part of the configuration management baseline. Given the Class A classification, no formal tool qualification report is produced; tool defects are handled through the standard problem resolution process.


[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):

"The NurseCall Hub addresses IEC 62304 Clause 5.3.7 for user acceptance testing and Clause 9.9 for post-market surveillance."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.3.7 and 9.9, neither of which exists. Clause 5.3 has 5.3.1 through 5.3.6 only. Clause 9 has 9.1 through 9.8 only. All clause 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 EchoAssist (echocardiogram analysis aid, Class B):

"All verification for the echocardiogram analysis aid 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 LabView Portal (read-only lab results viewer, Class A):

"Unit verification per IEC 62304 Clause 5.5 requires testing of all LabView Portal software units."

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


[System] You are an IEC 62304 regulatory documentation expert. 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 SeismicWatch Earthquake Early Warning, a Class A Seismic Early Warning Firmware. Reference IEC 62304 Clauses 5.7, 5.7.4.
Firmware for a network of MEMS accelerometers providing earthquake early warning by detecting P-waves and estimating magnitude.

[Assistant] Content: System tests for the SeismicWatch Earthquake Early Warning are executed on the Zynq-7000 SoC (FPGA + ARM) target with the Seismic Early Warning Firmware operating in its intended configuration. Test results are recorded per Clause 5.7.5, and the system test is verified complete per Clause 5.7.4 when all requirements have a linked passing test. No unit tests or integration tests are produced, as Class A does not require these verification levels.


[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 AssetTrack Equipment Inventory, a Class A Equipment Inventory System. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management only.

[Assistant] Content: Each risk control for the AssetTrack Equipment Inventory per Clause 7.2.1 specifies the hazard addressed, the control mechanism, and the verification method. Controls implemented in software per Clause 7.2.2 are traced through the requirements-design-test chain to ensure complete implementation and verification in the Equipment Inventory System.


[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 RetinaScan Pro (diabetic retinopathy screening AI, Class B):

"SOUP management follows applicable guidance and industry conventions. Third-party components are evaluated per best practices for the diabetic retinopathy screening AI."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "best practices", "applicable guidance", "industry conventions" provide no project-specific information about the RetinaScan Pro diabetic retinopathy screening AI. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

[User]
Review this documentation excerpt for the LabView Portal (read-only lab results viewer, Class A):

"Architectural design for the LabView Portal defines interfaces between software items per Clause 5.3.2."

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


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

[User]
Write a SRS section on data retention and integrity requirements for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clause 5.2.2.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: Persistent data managed by the CochleaMap CI Fitting Software includes configuration parameters, acquired measurements from electrode impedance measurement, and operational logs. Data integrity requirements specify error detection mechanisms and the Cochlear Implant Fitting Software response to data corruption events.


[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] Enumerate the requirements in IEC 62304 Clause 7.1.

[Assistant]
IEC 62304 Clause 7.1 (Analysis of software contributing to hazardous situations) contains the following sub-clauses:

- Clause 7.1: Analysis of software contributing to hazardous situations
- Clause 7.1.1: Identify items that could contribute to a hazardous situation
- Clause 7.1.2: Identify potential causes of contribution to a hazardous situation
- Clause 7.1.3: Evaluate published SOUP anomaly lists
- Clause 7.1.4: Document potential causes

These are the only valid sub-clauses under 7.1. No additional sub-clauses exist.


[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 WoundTrack (wound measurement imaging system, Class B):

"Software development follows IEC 62304 Clause 5.5.2.1 requirements for post-market surveillance."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.5.2.1 which does not exist. IEC 62304 has no four-level numbering. The reference must be corrected to a valid clause number.


[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 problem resolution process follows Clause 9. Problem reports are prepared per Clause 9.1, investigated per Clause 9.2, and resolved through the change control process per Clause 9.4. Trends are analyzed per Clause 9.6."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the ChemoCalc (chemotherapy dose calculator, Class C). Standards references are accurate.


[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] Does IEC 82304-1:2016 exist?

[Assistant] Yes. IEC 82304-1:2016 covers general requirements for health software product safety. Part 1 is the published normative standard.


[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 PedDose Pediatric Dosing App, a Class B Pediatric Dosing Calculator App. Reference IEC 62304 Clause 5.2.2.
Mobile reference app for pediatric drug dosing with weight-based calculations and age-specific ranges.

[Assistant] Content: The PedDose Pediatric Dosing App operates as a Pediatric Dosing Calculator App where Weight-based pediatric dose calculations with age-appropriate range checking. The software interfaces with external data sources and communicates via local drug database, manual input. The operational environment, user population, and regulatory context described here constrain the requirements that follow.


[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 PathCloud AI Histology Analyzer, a Class B Cloud SaMD Histopathology Analysis Platform. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Cloud-hosted SaMD analyzing whole-slide histology images with deep learning to flag suspicious regions for pathologist review. Runs as a multi-tenant SaaS.

[Assistant] Content: Requirements for the PathCloud AI Histology Analyzer Cloud SaMD Histopathology Analysis Platform 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 MedInventory (medical supply tracking system, Class A):

"The MedInventory verification approach includes system testing per Clause 5.7 with test cases documented in the software test plan. The developer may perform verification activities. Independent review is not required for Class A. No integration or unit testing is mandated for this medical supply tracking system."

[Assistant]
Verdict: PASS
Note: Content correctly limits Class A to system-level verification. 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 cybersecurity and health IT standards for NutriCalc TPN Formulation Tool, a Class B TPN Formulation Calculator. Reference IEC 62304 Clause 5.1.2.
Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

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


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

[User]
Write a SRS section on functional requirements overview for DoseCalc Medication Calculator, a Class B Medication Dose Calculator App. Reference IEC 62304 Clause 5.2.2.
Mobile app calculating medication doses based on patient weight, age, and renal function. Incorrect calculations could cause underdosing or adverse effects.

[Assistant] Content: The DoseCalc Medication Calculator functional requirements define what the Medication Dose Calculator App does in response to user inputs, sensor data, and system events. Requirements are organized by functional area: data acquisition, signal processing, display and output, and system management. Each requirement is individually testable.


[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 documenting failure modes and their effects for ChestAI Pulmonary Nodule Detector, a Class B AI Pulmonary Nodule Detection SaMD. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Cloud AI SaMD analyzing chest CT scans to detect and measure pulmonary nodules, providing CAD overlay for radiologist review. FDA De Novo pathway.

[Assistant] Content: Documentation of ChestAI Pulmonary Nodule Detector failure modes follows Clause 7.1.4. Each entry in the FMEA register includes: the software item, the failure mode, the potential cause(s), the effect on the AI Pulmonary Nodule Detection SaMD during Computer-aided detection and measurement of pulmonary nodules on chest CT for radiologist review, severity and probability ratings, and references to applicable risk control measures.


[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):

"IEC 62311-1 Section 5.2 requires all software units to be verified."

[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 ThermoGuard (body temperature logger, Class A):

"IEC 62311-1 Section 9.1 requires all software units to be verified."

[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 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 comprehensive deliverables list for Class C for AnesBot Automated Anesthesia Controller, a Class C Automated Anesthesia Delivery Software. Reference IEC 62304 Clause 5.1.8.
Software controlling target-controlled infusion of propofol based on BIS monitoring. Overdose could cause respiratory arrest.

[Assistant] Content: The AnesBot Automated Anesthesia Controller Automated Anesthesia Delivery Software requires the maximum documentation set under IEC 62304 Class C. Deliverables include planning documents (SDP), requirements (SRS), design documents (SAD, Detailed Design), verification records (unit, integration, and system test reports with coverage metrics), the traceability matrix, and the risk management file. Every deliverable is independently reviewed and approved.


[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 HydroRemind Hydration Tracker, a Class A Hydration Tracking Firmware. Reference IEC 62304 Clause 5.2.2.
Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

[Assistant] Content: The HydroRemind Hydration Tracker performance requirements define measurable bounds on processing latency, data throughput, and memory utilization. The Hydration Tracking Firmware must sustain these performance levels under peak operating conditions on nRF52840 throughout the full duration of Passive display of daily water consumption for wellness.


[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 threat model data flow decomposition for RemotICU Continuous Monitoring Hub, a Class B Edge-to-Cloud ICU Monitoring Gateway. Reference IEC 62304 Clause 5.2.2.
Edge gateway collecting data from bedside monitors (SpO2, HR, BP, ventilator) and streaming to cloud for trending, alerting, and tele-ICU review.

[Assistant] Content: The RemotICU Continuous Monitoring Hub threat model decomposes the Edge-to-Cloud ICU Monitoring Gateway into data flow diagrams showing all external entities, processes, data stores, and data flows. Each data flow crossing a trust boundary is analyzed for threats. The decomposition covers SpO2 module input, internal processing, and output via HL7v2 ADT/ORU.


[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 FactoryTemp Industrial Temperature Monitor, a Class A Industrial Temperature Monitoring Firmware. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Firmware monitoring factory floor temperatures from distributed thermocouple arrays. Logs data for process control compliance.

[Assistant] Content: Requirements in this SRS are identified using the format SRS-FAC-NNN, where NNN is a sequential number. Each requirement states a single testable capability per Clause 5.2.2 and is classified as functional, performance, interface, or safety. Derived requirements that do not trace to a system requirement are flagged for separate review.


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

[User]
Write a SDP section on Class B classification justification and implications for PharmaSafe CDSS, a Class B Clinical Decision Support System. Reference IEC 62304 Clause 4.3.
Clinical decision support system integrated into hospital EMR providing real-time drug-drug interaction alerts, allergy checking, and dosing guidance.

[Assistant] Content: Safety classification analysis per Clause 4.3 determined that the PharmaSafe CDSS is Class B. The Clinical Decision Support System can contribute to a hazardous situation during Real-time clinical decision support for medication safety including interaction checking and dose validation, but the hazard severity is limited to non-serious injury due to mitigating controls in the clinical environment. Architectural documentation and integration testing are mandated at this classification level.