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

[User]
Write a FMEA section on failure mode identification approach for AutoHUD Heads-Up Display Controller, a Class A Automotive HUD Controller Firmware. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Firmware rendering vehicle speed, navigation, and ADAS warnings on a windshield-projected heads-up display.

[Assistant] Content: The failure mode identification for the AutoHUD Heads-Up Display Controller Automotive HUD Controller Firmware per Clause 7.1.2 considers every processing step from input to output. Failure categories include data corruption, computation error, timing fault, and communication loss. Each failure mode is linked to its potential causes, including SOUP defects evaluated per Clause 7.1.3.


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

[User]
Write a SDP section on purpose and scope for Class B with moderate documentation for AnticoagCalc INR Dose Adjuster, a Class B Anticoagulation Dosing Support Tool. Reference IEC 62304 Clause 5.1.1.
Web tool suggesting warfarin dose adjustments based on INR readings and patient history. Clinical decision support requiring physician review.

[Assistant] Content: Development of the AnticoagCalc INR Dose Adjuster proceeds under this plan, which addresses all IEC 62304 Clause 5.1.1 requirements applicable to Class B medical device software. The Anticoagulation Dosing Support Tool can contribute to a hazardous situation, but external risk controls prevent escalation to serious injury. Documentation includes the SDP, SRS, Software Architecture Document, integration and system test records, and the risk management file.


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

[User]
Write a SRS section on data format and interoperability requirements for ClinTrial EDC Platform, a Class A Clinical Trial EDC Web Platform. Reference IEC 62304 Clause 5.2.2.
Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

[Assistant] Content: The ClinTrial EDC Platform Clinical Trial EDC Web Platform data exchange formats are specified in this SRS with field-level definitions, data types, units, and valid ranges. The software performs schema validation on all incoming data from REST API before processing.


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

[User]
Write a SDP section on purpose and scope for Class B with moderate documentation for TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clause 5.1.1.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

[Assistant] Content: Development of the TriageAI Emergency Triage Assistant proceeds under this plan, which addresses all IEC 62304 Clause 5.1.1 requirements applicable to Class B medical device software. The ED Triage Decision Support App can contribute to a hazardous situation, but external risk controls prevent escalation to serious injury. Documentation includes the SDP, SRS, Software Architecture Document, integration and system test records, and the risk management file.


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

[User]
Write a SRS section on purpose of the SRS document for FallRisk Inpatient Assessment Tool, a Class B Fall Risk Assessment App. Reference IEC 62304 Clause 5.2.1.
Web app calculating fall risk scores for inpatients based on mobility, medication, and cognitive assessments.

[Assistant] Content: The SRS for the FallRisk Inpatient Assessment Tool documents every functional, performance, interface, and safety requirement governing the Fall Risk Assessment App. Requirements originate from the system specification, the ISO 14971 risk analysis, and regulatory requirements. Traceability per Clause 5.2.1 links each requirement to its source and forward to its verification activity.


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

[User]
Expand requirement SRS-FUNC-004: "initialization integrity checks" (Category: functional)
Project: InfuRate IV Flow Calculator | Infusion Rate Calculator | Class B
Calculating IV infusion rates from prescribed doses, concentrations, and patient parameters. Desktop calculator for IV infusion rates based on drug concentration, patient weight, and ordered dose. Clinical decision support tool.

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 InfuRate IV Flow Calculator startup sequence shall include diagnostic checks of all critical subsystems and report any detected faults before allowing operational use.
Rationale: Startup verification prevents the Infusion Rate Calculator from operating with undetected faults that could affect output accuracy.
Priority: Mandatory
Acceptance Criterion: Self-test completes within the specified startup time and correctly detects each of the following injected faults: sensor disconnection, memory corruption, and display failure.
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 HeartLink (cardiac telemetry system, Class B):

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

[User]
Expand requirement SRS-DATA-001: "data integrity validation" (Category: data)
Project: TriagePro Emergency Scoring App | Emergency Department Triage SaMD | Class B
Guiding emergency department triage scoring using the Manchester Triage System protocol. Standalone tablet app implementing Manchester Triage System scoring. Guides clinicians through triage flowchart and records patient acuity level.

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 TriagePro Emergency Scoring App shall detect corrupted measurement records through integrity checking and flag affected entries for review.
Rationale: Corrupted data must be identified to prevent clinical decisions based on unreliable measurements.
Priority: Mandatory
Acceptance Criterion: Intentionally corrupted records are detected and flagged with 100% detection rate across 100 injected corruption events.
Source: System requirement


[System] You are 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 HemaCount Digital Cell Counter, a Class B IVD Digital Cell Counter Software. Reference IEC 62304 Clause 5.2.2.
Desktop software performing automated differential white blood cell counting on digitized blood smear images using computer vision.

[Assistant] Content: The HemaCount Digital Cell Counter resource constraints are derived from the Windows desktop with GPU hardware capabilities. Requirements specify headroom margins for memory and processing to ensure the IVD Digital Cell Counter Software remains stable under sustained operation during Automated white blood cell differential counting from digitized peripheral blood smear images.


[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 development follows ISO 62304 for the software lifecycle."

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


[System] You are a 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-003: "real-time data presentation on BLE 5.0" (Category: functional)
Project: PressoTrack Blood Pressure Trending | Ambulatory Blood Pressure Monitor Firmware | Class B
Automated periodic blood pressure measurement and trending over 24 hours. Firmware for an automated blood pressure cuff that trends readings over 24 hours. Trending errors could mask hypertensive episodes.

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: Output presentation on the BLE 5.0 shall refresh at the configured interval, reflecting the most recent processed data from the Ambulatory Blood Pressure Monitor Firmware pipeline.
Rationale: Display freshness is critical for the Ambulatory Blood Pressure Monitor Firmware to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: Measured display update interval is within 10% of the specified refresh period across 100 consecutive update cycles.
Source: User need


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

[User]
Expand requirement SRS-FUNC-004: "initialization integrity checks" (Category: functional)
Project: PathCloud AI Histology Analyzer | Cloud SaMD Histopathology Analysis Platform | Class B
AI-assisted identification of suspicious regions in digitized histology slides for pathologist review. Cloud-hosted SaMD analyzing whole-slide histology images with deep learning to flag suspicious regions for pathologist review. Runs as a multi-tenant SaaS.

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 PathCloud AI Histology Analyzer startup sequence shall include diagnostic checks of all critical subsystems and report any detected faults before allowing operational use.
Rationale: A power-on self-test confirms hardware and software readiness before the Cloud SaMD Histopathology Analysis Platform begins use.
Priority: Mandatory
Acceptance Criterion: Self-test completes within the specified startup time and correctly detects each of the following injected faults: sensor disconnection, memory corruption, and display failure.
Source: System requirement


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

[User]
Write a SDP section on primary international standards applicable to development for InhaleSense Smart Inhaler Tracker, a Class A Smart Inhaler Adherence Tracker. Reference IEC 62304 Clause 5.1.2.
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 software lifecycle for the InhaleSense Smart Inhaler Tracker is executed under IEC 62304:2006+AMD1:2015, with risk management per ISO 14971:2019 integrated at each phase gate. Quality system requirements follow ISO 13485:2016, and usability validation of the Smart Inhaler Adherence Tracker follows IEC 62366-1:2015+AMD1:2020.


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

[User]
Write a SRS section on safety requirements for Class A -- confirms no safety functions for CleanRoom Particle Counter Logger, a Class A Cleanroom Environmental Logger. Reference IEC 62304 Clauses 5.2.2, 5.2.3.
Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

[Assistant] Content: As a Class A system, the CleanRoom Particle Counter Logger does not implement software safety functions. The Cleanroom Environmental Logger presents optical particle counter for informational purposes only. No risk control measure per Clause 5.2.3 is implemented in software -- all identified risks are addressed by the informational-only design.


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

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

"REQ-SRS-056: Upon detecting a communication timeout with the sensor module, the BloodBank Manager shall display a warning indicator within 1 second and log the event. Acceptance criterion: simulate timeout and verify warning display timing and log entry. Priority: Mandatory. Source: Risk control."

[Assistant]
Verdict: PASS
Note: Content requirement is properly structured with measurable acceptance criteria; risk management content follows ISO 14971 framework. Standards references are accurate.


[System] You are an IEC 62304 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 HydroLog (hydration tracking wellness app, Class A):

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

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62311-1" which is incorrect. IEC 62311 covers EMF exposure limits, not medical device software. All references must be corrected.


[System] You are 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):

"Verification of the NurseCall Hub requires peer review of all design documents by an independent quality assurance reviewer prior to implementation."

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


[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):

"Referenced standards for the MedInventory 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 an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-SAFE-001: "fault response and safe shutdown" (Category: safety)
Project: LinacControl Beam Delivery System | Linear Accelerator Control Software | Class C
Controlling radiation beam delivery including gantry position, collimator settings, and dose monitoring. Software controlling linear accelerator beam delivery during radiation therapy. Beam-on errors could deliver lethal radiation doses.

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: Upon detection of a critical software fault, the LinacControl Beam Delivery System shall transition to its defined safe state within the specified time, disabling any active output that could contribute to harm.
Rationale: Fail-safe behavior is essential to prevent the Linear Accelerator Control Software from causing harm when its software detects an unrecoverable error.
Priority: Mandatory
Acceptance Criterion: Safe state transition completes within the specified time limit for each defined critical fault, verified by fault injection during operation.
Source: Risk control


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

[User]
Write a FMEA section on FMEA scope for Class C -- comprehensive analysis for StrokeAlert CT Perfusion Analyzer, a Class C AI Stroke Triage CT Perfusion SaMD. Reference IEC 62304 Clause 7.1.1.
Time-critical cloud SaMD processing CT perfusion scans to generate ischemic core and penumbra maps for acute stroke triage. Results pushed to mobile app within 5 minutes.

[Assistant] Content: Failure mode analysis for the Class C StrokeAlert CT Perfusion Analyzer examines every software item in the AI Stroke Triage CT Perfusion SaMD architecture for potential contributions to hazardous situations per Clause 7.1.1. The analysis assigns severity, probability, and detectability ratings to each failure mode. All failure modes with unacceptable risk have corresponding risk control measures traced to software requirements.


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

[User]
Write a SAD section on purpose of the architecture document for SurgiPlan 3D Surgical Planner, a Class B 3D Surgical Planning SaMD. Reference IEC 62304 Clause 5.3.1.
Desktop SaMD for orthopedic surgeons to plan joint replacement procedures on 3D CT reconstructions. Outputs implant sizing and positioning specifications.

[Assistant] Content: The SurgiPlan 3D Surgical Planner Software Architecture Document establishes the high-level design structure of the 3D Surgical Planning SaMD per Clause 5.3.1. It defines the decomposition into software items, their interfaces, and the rationale for design decisions including technology choices and architectural patterns on Windows/macOS desktop with GPU.


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

[User]
Write a SRS section on user interaction requirements for PainScale Digital Assessment Tool, a Class B Pain Assessment Tool. Reference IEC 62304 Clause 5.2.2.
Web app for standardized pain assessment using validated scales (VAS, NRS, McGill). Records longitudinal pain data for treatment monitoring.

[Assistant] Content: The PainScale Digital Assessment Tool Pain Assessment Tool presents information to the user via web form and accepts user input through defined interaction patterns. User interaction requirements are traceable to the usability engineering file per IEC 62366-1:2015+AMD1:2020.


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

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

"The PillRemind lifecycle follows an industry-standard methodology ensuring compliance with applicable regulations. Phase gates are established at appropriate milestones."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "industry-standard", "appropriate milestones" provide no project-specific information about the PillRemind medication reminder app. 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 hazard identification for the specific device for HydroRemind Hydration Tracker, a Class A Hydration Tracking Firmware. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

[Assistant] Content: Software-related hazard causes for the HydroRemind Hydration Tracker Hydration Tracking Firmware are documented per Clause 7.1.2 and Clause 7.1.4. Risk control measures per Clause 7.2.1 address each identified cause through input validation, range checking, communication integrity verification, and fail-safe defaults.


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

[User]
Write a SDP section on risk control requirements traceability for ConveyorGuard Safety Interlock System, a Class A Conveyor Safety Interlock Software. Reference IEC 62304 Clause 5.2.3.
Safety PLC program monitoring conveyor belt guard positions, emergency stops, and light curtains. Functional safety application.

[Assistant] Content: Risk control measures identified in the ISO 14971 risk management process are traced to specific software requirements per Clause 5.2.3. For the ConveyorGuard Safety Interlock System, this includes controls addressing guard position switches failure modes, communication integrity on safety PLC I/O, and data validation.


[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 sensor and communication protocol requirements for PowerTrack UPS Monitor, a Class A UPS Monitoring Software. Reference IEC 62304 Clause 5.2.2.
Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

[Assistant] Content: The PowerTrack UPS Monitor communication interfaces include SNMP, Modbus TCP connecting the UPS Monitoring Software to external systems and sensors. Each interface requirement specifies the expected behavior under normal operation and the response to communication failure conditions.


[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):

"Documentation is prepared in accordance with standard templates and guidelines. Review cycles are established at appropriate intervals for the patient call system dashboard."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "appropriate intervals" provide no project-specific information about the NurseCall Hub patient call system dashboard. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


[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 B -- integration and system testing for InfuRate IV Flow Calculator, a Class B Infusion Rate Calculator. Reference IEC 62304 Clauses 5.6, 5.6.3, 5.7.
Desktop calculator for IV infusion rates based on drug concentration, patient weight, and ordered dose. Clinical decision support tool.

[Assistant] Content: The Class B verification strategy for the InfuRate IV Flow Calculator includes integration testing per Clause 5.6 and system testing per Clause 5.7. Integration tests validate the interaction between input processing, desktop GUI communication, and output subsystems. System tests confirm end-to-end behavior of the Infusion Rate Calculator against the SRS.


[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 TempWatch Body Temperature Logger, a Class A Temperature Logging Firmware. Reference IEC 62304 Clause 5.2.6.
Firmware for a wearable temperature patch that logs skin temperature over 24 hours and displays trends. No fever detection or alerts.

[Assistant] Content: Verification of TempWatch Body Temperature Logger 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 Temperature Logging Firmware.


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

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

"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 PacePilot pacemaker programmer. 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 requirements conventions and identification scheme for AuditTrail QMS Event Logger, a Class A QMS Audit Trail Service. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Microservice capturing and storing quality management system audit events. Logging and reporting only.

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


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

[User]
Write a TRACE section on traceability scope including risk controls for RetinaScan Diabetic Retinopathy Screener, a Class B Retinal Screening Software. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Desktop software analyzing retinal fundus images to detect signs of diabetic retinopathy for ophthalmologist review.

[Assistant] Content: The RetinaScan Diabetic Retinopathy Screener traceability matrix extends beyond functional requirements to include risk control traceability per Clause 7.3.2. Each risk control measure implemented in the Retinal Screening Software software is traced from the ISO 14971 hazard through the software requirement to the verification test confirming its effectiveness.


[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):

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

[Assistant]
Verdict: PASS
Note: Content requirement is properly structured with measurable acceptance criteria; risk management content follows ISO 14971 framework. Standards references are accurate.


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

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

"Release activities follow standard practices to ensure quality and traceability. The release package is prepared as needed for regulatory submission."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as needed", "standard practices" provide no project-specific information about the CardioPulse Monitor cardiac rhythm monitor. 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 SAD section on architecture verification scope for NeoVent Neonatal Ventilator, a Class C Neonatal Ventilator Firmware. Reference IEC 62304 Clauses 5.3.1, 5.3.6.
Neonatal ventilator firmware supporting CPAP, NIPPV, and conventional ventilation for extremely premature infants. Tidal volumes as low as 2 mL.

[Assistant] Content: Architecture verification for the NeoVent Neonatal Ventilator per Clause 5.3.6 confirms traceability from requirements to architectural elements, adequacy of interface definitions, and correct implementation of risk control measures in the Neonatal Ventilator Firmware design.


[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 RoomBoard Digital Signage, a Class A Patient Room Digital Signage. Reference IEC 62304 Clause 5.2.2.
Hospital room digital signage displaying patient name, care team, and daily schedule. Display-only, no clinical data entry.

[Assistant] Content: Timing requirements for the RoomBoard Digital Signage include end-to-end latency from sensor acquisition to display update, processing throughput for sustained data streams, and startup time. Each timing requirement has a specific numeric bound and is verified through system testing of the Patient Room Digital Signage.


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

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

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

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


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

[User]
Write a SDP section on milestones and phase transition criteria for BrachyDose HDR Afterloader Controller, a Class C HDR Brachytherapy Afterloader Firmware. Reference IEC 62304 Clause 5.1.1.
Firmware controlling high-dose-rate brachytherapy source positioning and dwell times. Source positioning errors cause lethal local radiation.

[Assistant] Content: Transition between lifecycle phases requires completion of all phase-gate deliverables and sign-off by the designated reviewers. For the BrachyDose HDR Afterloader Controller project, key milestones include the Software Requirements Baseline (all requirements reviewed and traced to system requirements), the Design Freeze (architecture and interfaces finalized), and the Release Readiness Review (all verification complete and anomalies dispositioned).


[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 ECGInsight Rhythm Interpreter, a Class B ECG Interpretation Service. Reference IEC 62304 Clause 5.7.1.
Cloud service analyzing 12-lead ECG recordings and generating preliminary rhythm interpretations for physician review.

[Assistant] Content: The purpose of this traceability matrix is to confirm complete coverage of the ECGInsight Rhythm Interpreter software requirements through design and verification per Clause 5.7.1. Bidirectional tracing enables identification of gaps (unimplemented requirements) and orphans (implementations without requirements) in the ECG Interpretation Service.


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

[User]
Write a SAD section on purpose of the architecture document for FetalGuard Heart Rate Monitor, a Class B Fetal Heart Rate Monitor Firmware. Reference IEC 62304 Clause 5.3.1.
External fetal heart rate monitor firmware using Doppler ultrasound. Displays fetal heart rate and variability during labor.

[Assistant] Content: The purpose of this document is to define the software architecture of the FetalGuard Heart Rate Monitor Fetal Heart Rate Monitor Firmware as required by IEC 62304 Clause 5.3.1. The architecture identifies software items, their interfaces, and their interactions, providing the basis for integration testing and traceability to requirements.


[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 tool qualification for Class B and C for DialyFlow Dialysis Fluid Controller, a Class C Hemodialysis Fluid Controller Firmware. Reference IEC 62304 Clause 5.1.4.
Firmware controlling dialysate flow rates and composition in a hemodialysis machine. Fluid balance errors could be fatal.

[Assistant] Content: The C (embedded, IEC 61508 SIL 2) compiler, test framework, and coverage analysis tools used for the DialyFlow Dialysis Fluid Controller are qualified per Clause 5.1.4. Qualification includes comparison of tool output against known-correct reference results and documentation of tool version, configuration, and any known limitations affecting the Hemodialysis Fluid Controller Firmware verification.


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

[Assistant] Content: The FactoryTemp Industrial Temperature Monitor operates as a Industrial Temperature Monitoring Firmware where Continuous monitoring and logging of factory floor temperatures for process control. The software interfaces with K-type thermocouples (x16) and communicates via Modbus RTU, 4-20mA. The operational environment, user population, and regulatory context described here constrain the requirements that follow.


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

[User]
Review this documentation excerpt for the StepTrack (wellness pedometer app, Class A):

"Detailed design documentation per Clause 5.4 is produced for every software unit of the StepTrack."

[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 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 CardioPulse Monitor (cardiac rhythm monitor, Class B):

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

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


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

[User]
Write a SRS section on data retention and integrity requirements for AssetTrack Equipment Inventory, a Class A Equipment Inventory System. Reference IEC 62304 Clause 5.2.2.
Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management only.

[Assistant] Content: The AssetTrack Equipment Inventory data requirements define how the Equipment Inventory System stores, retrieves, and protects data acquired during Tracking location and status of medical equipment for inventory management. Requirements specify data format, retention duration, backup frequency, and the behavior when data corruption is detected.


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

[User]
Write a SAD section on architectural overview for Class B for TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clauses 5.3.1, 5.3.2.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

[Assistant] Content: Architectural design of the TriageAI Emergency Triage Assistant uses a modular decomposition that separates input handling, business logic, and output generation. Each module has a defined interface per Clause 5.3.2. The ED Triage Decision Support App architecture on iPad web app facilitates integration testing at module boundaries.


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

"Configuration management for the MedInventory follows Clause 8. Configuration items are identified per Clause 8.1.1, SOUP is identified per Clause 8.1.2, and change control is managed per Clause 8.2. Status accounting is maintained per Clause 8.3."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the MedInventory (medical supply tracking system, Class A). 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 THREAT section on STRIDE mitigations traced to requirements for ThermoWatch Core Temperature Monitor, a Class B Core Temperature Monitor Firmware. Reference IEC 62304 Clause 5.2.3.
Continuous core temperature monitoring firmware using an ingestible sensor pill. Displays temperature trend with configurable alerts.

[Assistant] Content: Threat-to-mitigation traceability for the ThermoWatch Core Temperature Monitor Core Temperature Monitor Firmware is maintained per Clause 5.2.3. Each STRIDE threat is mapped to a security requirement, an implementation, and a verification test. This traceability ensures no identified threat lacks a corresponding software control.


[System] You are 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 StepTrack (wellness pedometer app, Class A):

"Detailed design for the StepTrack documents algorithms, data structures, and internal interfaces for each software unit per Clause 5.4.2."

[Assistant]
Verdict: FAIL
Note: Content mandates detailed design per Clause 5.4.2 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 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 MedInventory (medical supply tracking system, Class A):

"All interface points between MedInventory modules are covered by integration test cases."

[Assistant]
Verdict: FAIL
Note: Content mandates integration testing for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Integration testing (Clause 5.6) is not required for Class A.


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

[User]
Write a SDP section on requirements elicitation and documentation for GaitSense Walking Analysis, a Class B Gait Analysis Insole Firmware. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Instrumented insole firmware analyzing gait patterns and detecting asymmetries. Reports generated for orthopedic assessment.

[Assistant] Content: The GaitSense Walking Analysis software requirements are captured in the SRS per Clause 5.2.1. Sources include system requirements for the Gait Analysis Insole Firmware, risk control measures from the ISO 14971 analysis, and regulatory requirements from the target markets. Each requirement is verifiable and traceable.


[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 elicitation and documentation for ClinTrial EDC Platform, a Class A Clinical Trial EDC Web Platform. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

[Assistant] Content: Software requirements for the ClinTrial EDC Platform are derived from system requirements, the risk management file, and stakeholder inputs per Clause 5.2.1. Each requirement specifies functional behavior, performance criteria, or interface constraints relevant to the Clinical Trial EDC Web Platform and its use in Electronic capture and management of clinical trial data across multiple investigator sites.


[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):

"For the NeuroStim Programmer, 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 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-003: "audit trail and data export" (Category: functional)
Project: VitalPulse SpO2 Monitor | Pulse Oximeter Firmware | Class B
Continuous monitoring of blood oxygen saturation and pulse rate with clinical alarms. Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

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 VitalPulse SpO2 Monitor shall log measurement data with timestamps to non-volatile storage and provide a mechanism to retrieve logged data via I2C.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Pulse Oximeter Firmware.
Priority: Desirable
Acceptance Criterion: Logged data is retrievable after power cycle, with all timestamps accurate to within 1 second of the reference clock.
Source: User need


[System] You are 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 DermaLens Teledermatology Platform, a Class B Cloud Teledermatology SaMD. Reference IEC 62304 Clause 5.2.2.
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: Data requirements for the DermaLens Teledermatology Platform specify retention periods, storage formats, and integrity controls for all persistent data managed by the Cloud Teledermatology SaMD. Data integrity is ensured through checksums or cryptographic hashes, and corrupted data is detected before use in any processing function.


[System] You are an IEC 62304 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):

"SOUP management for the DialysisGuard includes identification (Clause 8.1.2), functional specification (Clause 5.3.3), and anomaly list evaluation (Clause 7.1.3). SOUP items are version-controlled and changes are managed through the change control process (Clause 8.2)."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the DialysisGuard (hemodialysis machine 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 TRACE section on gap identification and coverage analysis for CleanRoom Particle Counter Logger, a Class A Cleanroom Environmental Logger. Reference IEC 62304 Clause 5.7.4.
Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

[Assistant] Content: The gap analysis for the CleanRoom Particle Counter Logger 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 Cleanroom Environmental Logger verification is complete per Clause 5.7.4.


[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 PulmoCheck Spirometry Analyzer, a Class B Spirometry Analysis Software. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

[Assistant] Content: The PulmoCheck Spirometry Analyzer risk control verification per Clause 7.3.1 exercises each control measure in isolation and in the context of the complete Spirometry Analysis Software. Clause 7.3.3 documentation records the verification method, the test result, and the conclusion regarding the control's effectiveness.


[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 test plan covers system-level tests only. Each requirement in the SRS maps to one or more system test cases. No unit or integration testing is planned for this Class A patient call system dashboard. Test execution is documented per Clause 5.7.5."

[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. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a TRACE section on purpose and scope of the traceability matrix for HeartView Resting HR Display, a Class A Heart Rate Display Firmware. Reference IEC 62304 Clause 5.7.1.
Wearable firmware that shows resting heart rate on a small OLED screen. Read-only display with no arrhythmia detection or clinical alerts.

[Assistant] Content: Traceability for the HeartView Resting HR Display per Clause 5.7.1 links system requirements to software requirements, software requirements to design elements, and design elements to verification test cases. The matrix serves as the primary evidence that the Heart Rate Display Firmware verification is complete and that no requirement is unaddressed.


[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 RadView DICOM (DICOM image viewer, Class A):

"Software development follows IEC 62304 Clause 5.10 requirements for continuous monitoring."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.10 which does not exist. Clause 5 ends at 5.8. 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 NurseCall Hub (patient call system dashboard, Class A):

"MC/DC coverage of 80% is required for all safety-critical modules of the NurseCall Hub."

[Assistant]
Verdict: FAIL
Note: Content mandates code coverage targets for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Coverage targets are Class B/C considerations. Class A has no coverage requirements.


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

[User]
Expand requirement SRS-DATA-002: "stored data corruption detection" (Category: data)
Project: GlucoEdge Continuous Glucose Platform | Hybrid CGM Edge-Cloud Platform | Class B
Continuous glucose monitoring with edge processing on wearable and cloud-based trend analysis for clinician review. Hybrid system: embedded BLE firmware on a wearable CGM patch streams readings to a phone app, which uploads to cloud for trend analysis and physician dashboard.

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

[Assistant]
Description: Data integrity of all stored records in the Hybrid CGM Edge-Cloud Platform shall be verified using CRC or equivalent checksums upon read-back.
Rationale: Data integrity mechanisms ensure measurement records retrieved from the Hybrid CGM Edge-Cloud Platform are trustworthy for clinical review.
Priority: Mandatory
Acceptance Criterion: Intentionally corrupted records are detected and flagged with 100% detection rate across 100 injected corruption events.
Source: System requirement


[System] You are 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: "device configuration management" (Category: functional)
Project: SupplyChain Procurement Portal | Supply Chain Procurement System | Class A
Managing procurement of medical supplies with approval tracking. Web portal for ordering medical supplies with approval workflows. Procurement and logistics 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 SupplyChain Procurement Portal shall allow authorized users to configure operating parameters via REST API and persist settings across power cycles.
Rationale: Configurable parameters allow the Supply Chain Procurement System 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 InfuSafe Controller (insulin infusion pump controller, Class C):

"The development plan references IEC 62304 Clause 5.7.6 and Clause 5.0 for the InfuSafe Controller."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.7.6 and 5.0, neither of which exists. Clause 5.7 has 5.7.1 through 5.7.5 only. 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 ThermoGuard (body temperature logger, Class A):

"The ThermoGuard addresses IEC 62304 Clause 4.5 for deployment validation and Clause 7.5 for user acceptance testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 4.5 and 7.5, neither of which exists. Clause 4 only has 4.1, 4.2, 4.3. Clause 7 ends at 7.4. 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 SleepWell (sleep quality display app, Class A):

"REQ-SRS-001: The SleepWell shall display the current reading within 2 seconds of receiving data from the sensor interface. Acceptance criterion: measured latency from data receipt to display update is less than 2000 ms in 95% of test runs. Priority: Mandatory. Source: User need."

[Assistant]
Verdict: PASS
Note: Content requirement is properly structured with measurable acceptance criteria. 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 NurseCall Hub (patient call system dashboard, Class A):

"Software problem resolution follows ISO 14971-2 Clause 9."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 14971-2" which is incorrect. ISO 14971 has no Part 2. ISO/TR 24971:2020 is a separate technical report. All references must be corrected.


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

[User]
Write a SRS section on resource constraints and scalability for VisitorPass Access Management, a Class A Visitor Management System. Reference IEC 62304 Clause 5.2.2.
Kiosk application for visitor registration and badge printing in hospital lobbies. Administrative access control.

[Assistant] Content: Resource requirements for the VisitorPass Access Management specify maximum memory utilization, persistent storage consumption, and processor loading on Windows kiosk. The Visitor Management System must operate within these constraints under worst-case conditions without degradation of safety-relevant functions.


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

[User]
Expand requirement SRS-INTF-003: "data export and interoperability" (Category: interface)
Project: SterilLog Sterilization Record System | Sterilization Record Logger | Class A
Recording and archiving sterilization cycle parameters for regulatory compliance. Software logging sterilization cycle parameters from autoclaves. Records temperature, pressure, and time for compliance documentation.

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 SterilLog Sterilization Record System shall exchange data with external systems via RS-232 using the specified message format with error handling.
Rationale: Interoperability enables integration of Sterilization Record Logger data into the clinical workflow and patient record.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


[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] List all valid IEC 62304 sub-clauses under Clause 5.5 and their subjects.

[Assistant]
IEC 62304 Clause 5.5 (Software unit implementation and verification) contains the following sub-clauses:

- Clause 5.5: Software unit implementation and verification
- Clause 5.5.1: Implement each software unit
- Clause 5.5.2: Establish software unit verification process
- Clause 5.5.3: Software unit acceptance criteria
- Clause 5.5.4: Additional software unit acceptance criteria
- Clause 5.5.5: Software unit verification

These are the only valid sub-clauses under 5.5. No additional sub-clauses exist.


[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 GlucoEdge Continuous Glucose Platform, a Class B Hybrid CGM Edge-Cloud Platform. Reference IEC 62304 Clause 5.2.2.
Hybrid system: embedded BLE firmware on a wearable CGM patch streams readings to a phone app, which uploads to cloud for trend analysis and physician dashboard.

[Assistant] Content: Functional requirements for the GlucoEdge Continuous Glucose Platform specify the data processing, user interaction, and output generation capabilities of the Hybrid CGM Edge-Cloud Platform. Each requirement describes a discrete function the software shall perform during Continuous glucose monitoring with edge processing on wearable and cloud-based trend analysis for clinician review, with acceptance criteria sufficient to derive verification test cases.


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

[User]
Write a SRS section on operational context and user population for TeleRehab Remote Patient Monitor, a Class B Remote Rehabilitation Platform. Reference IEC 62304 Clause 5.2.2.
Platform enabling remote physiotherapy with video consultations and wearable sensor data streaming. Generates exercise adherence reports.

[Assistant] Content: The TeleRehab Remote Patient Monitor Remote Rehabilitation Platform is deployed in an environment where Remote physiotherapy monitoring with exercise tracking and therapist-patient video sessions. Users include trained clinical staff and, where applicable, patients or caregivers. The Web + iOS platform defines the computational environment, while WebRTC provides the primary data communication pathway.


[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):

"SOUP management follows applicable guidance and industry conventions. Third-party components are evaluated per best practices for the ICU ventilator controller."

[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 VentAssist Pro ICU ventilator controller. 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 risk control requirements traceability for MedRef Clinical Reference App, a Class A Clinical Drug Reference App. Reference IEC 62304 Clause 5.2.3.
Standalone mobile app providing searchable drug reference database with interaction checker. Display-only — no prescription or dosing decisions.

[Assistant] Content: Clause 5.2.3 requires that risk control measures implemented in the MedRef Clinical Reference App software appear as traceable requirements. The traceability chain runs from the ISO 14971 hazard analysis to the SRS requirement to the test case verifying the control's effectiveness in the Clinical Drug Reference App.


[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 risk control coverage verification for SurgLog Procedure Documentation App, a Class A Surgical Documentation App. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

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


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

[User]
Expand requirement SRS-SEC-001: "access control and authorization" (Category: security)
Project: RadOnco Cloud Treatment Planner | Cloud Radiation Treatment Planning SaMD | Class C
Cloud-based Monte Carlo dose calculation and treatment plan optimization for radiation oncology. Cloud-based radiation oncology treatment planning system using GPU clusters for Monte Carlo dose calculation. Treatment plans directly drive linear accelerator delivery.

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 RadOnco Cloud Treatment Planner shall require authentication before allowing modification of device configuration parameters via DICOM RT import/export.
Rationale: Unauthorized configuration changes to the Cloud Radiation Treatment Planning SaMD could compromise its intended function or patient safety.
Priority: Mandatory
Acceptance Criterion: Brute-force protection activates after the specified number of failed authentication attempts.
Source: Risk control


[System] You are 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 ArthroNav (surgical navigation system, Class C):

"Maintenance activities follow ISO 14971-2 Clause 6."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 14971-2" which is incorrect. ISO 14971 has no Part 2. ISO/TR 24971:2020 is a separate technical report. 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 HeartLink (cardiac telemetry system, Class B):

"In accordance with ISO 14901, verification activities include system testing."

[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 ThermoGuard (body temperature logger, Class A):

"All ThermoGuard software units shall undergo formal verification by an independent test team using white-box and black-box techniques."

[Assistant]
Verdict: FAIL
Note: Content mandates formal unit verification by independent test team for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Unit verification (Clause 5.5) and independent testing are not required for Class A.


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

"REQ-SRS-056: Upon detecting a communication timeout with the sensor module, the RadBeam Planner shall display a warning indicator within 1 second and log the event. Acceptance criterion: simulate timeout and verify warning display timing and log entry. Priority: Mandatory. Source: Risk control."

[Assistant]
Verdict: PASS
Note: Content requirement is properly structured with measurable acceptance criteria; risk management content follows ISO 14971 framework. Standards references are accurate.


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

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

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

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

"Every software item of the BloodBank Manager shall have a detailed design document reviewed by a qualified reviewer before implementation begins."

[Assistant]
Verdict: FAIL
Note: Content mandates detailed design with review 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 software.


[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 minimal deliverables list for Class A for SurgLog Procedure Documentation App, a Class A Surgical Documentation App. Reference IEC 62304 Clause 5.1.8.
Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

[Assistant] Content: Documentation planning per Clause 5.1.8 for the SurgLog Procedure Documentation App yields a minimal Class A deliverable set: SDP, SRS, system test plan, system test report, software release record, and risk management file. Deliverables associated with architectural design, detailed design, unit testing, and integration testing are excluded.


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

[User]
Expand requirement SRS-FUNC-006: "display update rate for Pain Assessment Tool" (Category: functional)
Project: PainScale Digital Assessment Tool | Pain Assessment Tool | Class B
Standardized pain intensity and quality assessment with longitudinal tracking for treatment evaluation. Web app for standardized pain assessment using validated scales (VAS, NRS, McGill). Records longitudinal pain data for treatment monitoring.

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 PainScale Digital Assessment Tool display shall present current readings on web form within the specified maximum update latency.
Rationale: Display freshness is critical for the Pain Assessment Tool to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: Measured display update interval is within 10% of the specified refresh period across 100 consecutive update cycles.
Source: User need


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

[User]
Expand requirement SRS-PERF-002: "memory usage budget" (Category: performance)
Project: GlucoSpot Continuous Glucose Display | CGM Display App | Class B
Displaying continuous glucose monitor readings with trend analysis and glucose range alerts. Mobile app receiving and displaying continuous glucose monitor readings via BLE. Shows trends, time-in-range, and configurable glucose alerts.

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 GlucoSpot Continuous Glucose Display shall operate within the specified RAM and flash memory budget on the iOS/Android platform, including all runtime allocations.
Rationale: Memory constraints are fixed by the iOS/Android 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 CaloriePal (nutrition tracking app, Class A):

"REQ-SRS-045: The CaloriePal software shall provide a mechanism to export all configuration parameters to a structured file format. The export shall include version metadata. Acceptance criterion: exported file can be parsed and all parameters match the current configuration. Priority: Desirable. Source: User need."

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


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

[User]
Expand requirement SRS-DATA-001: "stored data corruption detection" (Category: data)
Project: NeoVent Neonatal Ventilator | Neonatal Ventilator Firmware | Class C
Mechanical ventilatory support for neonatal patients with precise low-volume delivery. Neonatal ventilator firmware supporting CPAP, NIPPV, and conventional ventilation for extremely premature infants. Tidal volumes as low as 2 mL.

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

[Assistant]
Description: Data integrity of all stored records in the Neonatal Ventilator Firmware shall be verified using CRC or equivalent checksums upon read-back.
Rationale: Data integrity mechanisms ensure measurement records retrieved from the Neonatal Ventilator Firmware are trustworthy for clinical review.
Priority: Mandatory
Acceptance Criterion: Intentionally corrupted records are detected and flagged with 100% detection rate across 100 injected corruption events.
Source: System requirement


[System] You are an IEC 62304 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 RadView DICOM (DICOM image viewer, Class A):

"Software safety classification is performed per ISO 14971-2 Clause 4.3."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 14971-2" which is incorrect. ISO 14971 has no Part 2. ISO/TR 24971:2020 is a separate technical report. 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 internal SOPs and procedures for WaterPure Quality Logger, a Class A Water Quality Data Logger. Reference IEC 62304 Clause 5.1.2.
Embedded system logging purified water system parameters (conductivity, TOC, flow rate) for pharmaceutical manufacturing compliance.

[Assistant] Content: The WaterPure Quality Logger development team follows company SOPs aligned with ISO 13485:2016 quality management requirements: SOP-010 governs software planning, SOP-012 governs configuration management, and SOP-013 governs verification. Each SOP is version-controlled and reviewed annually to maintain compliance.


[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 MedImage PACS Viewer, a Class A Web PACS Image Viewer. Reference IEC 62304 Clause 5.7.4.
Web-based PACS viewer enabling radiologists to review DICOM images with standard tools (windowing, measurement, MPR). View-only, no AI or diagnostic processing.

[Assistant] Content: Coverage analysis for the MedImage PACS Viewer per Clause 5.7.4 confirms that every SRS requirement maps to at least one test case with a passing result. Requirements implementing risk controls are additionally confirmed to have adequate test coverage. The Web PACS Image Viewer release is contingent on 100% requirement coverage with no open gaps.


[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 internal SOPs and procedures for TriagePro Emergency Scoring App, a Class B Emergency Department Triage SaMD. Reference IEC 62304 Clause 5.1.2.
Standalone tablet app implementing Manchester Triage System scoring. Guides clinicians through triage flowchart and records patient acuity level.

[Assistant] Content: Work instructions for the TriagePro Emergency Scoring App are codified in SOPs maintained within the ISO 13485 quality management system. SOP-010 (development planning), SOP-011 (risk management), SOP-012 (configuration management), and SOP-013 (verification) define step-by-step procedures for each IEC 62304 lifecycle activity applicable to the Emergency Department Triage SaMD.


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

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

"The EchoAssist Class B development lifecycle includes requirements analysis (Clause 5.2), architectural design (Clause 5.3), implementation, and multi-level verification. Integration testing per Clause 5.6 validates component interactions. System testing per Clause 5.7 verifies end-to-end functionality."

[Assistant]
Verdict: PASS
Note: Content correctly specifies Class B requirements; 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 hazard identification for the specific device for BalanceBoard Vestibular Trainer, a Class B Balance Training Platform Firmware. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Force plate firmware measuring center-of-pressure excursions during balance exercises. Provides real-time visual biofeedback.

[Assistant] Content: The BalanceBoard Vestibular Trainer risk analysis per Clause 7.1.2 identifies software causes of hazardous situations specific to the Balance Training Platform Firmware: data path corruption, timing violations, resource exhaustion, and incorrect state transitions. Each cause is linked to a risk control measure per Clause 7.2.1 and implemented as a verifiable software 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 SAD section on interface design between software items for LinacControl Beam Delivery System, a Class C Linear Accelerator Control Software. Reference IEC 62304 Clause 5.3.2.
Software controlling linear accelerator beam delivery during radiation therapy. Beam-on errors could deliver lethal radiation doses.

[Assistant] Content: Internal interface design for the LinacControl Beam Delivery System follows Clause 5.3.2. Each interface is documented with its function signature, parameter constraints, return value semantics, and thread safety guarantees. The Linear Accelerator Control Software interfaces are designed for testability, supporting both integration testing and fault injection.


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

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

"The OxyPure Controller conforms to IEC 62304:2006+AMD1:2015. Safety classification per Clause 4.3 designates this oxygen concentrator controller as Class C. Risk management follows ISO 14971:2019 with guidance from ISO/TR 24971:2020."

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


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

[User]
Write a SDP section on SOUP identification and management for BSACalc Body Surface Area Tool, a Class B BSA Calculator Web App. Reference IEC 62304 Clause 8.1.2.
Web calculator for body surface area using Mosteller and DuBois formulas. Used for chemotherapy dose calculations.

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


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

[User]
Write a FMEA section on FMEA scope for Class A -- simplified analysis for PathSlide Digital Pathology Viewer, a Class A Digital Pathology Viewer. Reference IEC 62304 Clause 7.1.1.
Web viewer for whole-slide digital pathology images. Pan, zoom, and annotation display. No AI-assisted diagnosis.

[Assistant] Content: The PathSlide Digital Pathology Viewer FMEA scope is limited to confirmation that no software failure mode contributes to a hazardous situation, consistent with the Class A classification per Clause 7.1.1. The analysis covers data acquisition, processing, and display functions of the Digital Pathology Viewer and confirms that all failure effects are limited to loss of informational functionality.


[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 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: Threats to the FallRisk Inpatient Assessment Tool are categorized using the STRIDE framework: Spoofing of web form identity, Tampering with sensor data or configuration, Repudiation of clinical actions, Information Disclosure of patient data, Denial of Service disrupting Calculating fall risk scores for hospitalized patients to guide nursing interventions, and Elevation of Privilege through unauthorized parameter changes.


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

[User]
Write a SAD section on SOUP component integration and requirements for GlucoEdge Continuous Glucose Platform, a Class B Hybrid CGM Edge-Cloud Platform. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Hybrid system: embedded BLE firmware on a wearable CGM patch streams readings to a phone app, which uploads to cloud for trend analysis and physician dashboard.

[Assistant] Content: SOUP components in the GlucoEdge Continuous Glucose Platform are integrated through defined interfaces per Clause 5.3.3. For each component, the architecture specifies the functions used, the performance expectations, and the nRF52840 (firmware) + mobile + AWS Lambda requirements per Clause 5.3.4. SOUP anomaly evaluation per Clause 7.1.3 is documented in the risk management file.