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

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

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

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


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

[User]
Write a SDP section on problem reporting and investigation for ScreenFlow Population Health Screener, a Class A Serverless Population Health Screening SaMD. Reference IEC 62304 Clauses 9.1, 9.2.
Serverless cloud application processing population-level health screening questionnaires and flagging individuals for follow-up based on risk scoring algorithms.

[Assistant] Content: Software problems discovered during ScreenFlow Population Health Screener development are documented as problem reports per Clause 9.1, including a description of the anomaly, steps to reproduce, and the affected configuration item. Investigation per Clause 9.2 determines the root cause, assesses the impact on previously verified items, and identifies whether the problem affects the safety or effectiveness of the Serverless Population Health Screening 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 CaloriePal (nutrition tracking app, Class A):

"An independent safety reviewer shall verify all risk control measures implemented in the CaloriePal software before each release."

[Assistant]
Verdict: FAIL
Note: Content mandates independent safety review for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Independent verification is a Class C requirement, not required for Class A.


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

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

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

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


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

[User]
Expand requirement SRS-DATA-001: "stored data corruption detection" (Category: data)
Project: PharmLog Medication History Viewer | Medication History Viewer | Class A
Read-only display of medication dispensing history. Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

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 PharmLog Medication History Viewer shall detect corrupted measurement records through integrity checking and flag affected entries for review.
Rationale: Data integrity mechanisms ensure measurement records retrieved from the Medication History Viewer are trustworthy for clinical review.
Priority: Mandatory
Acceptance Criterion: Integrity check correctly identifies all corrupted records with zero false positives on uncorrupted data.
Source: System requirement


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

[User]
Write a SRS section on system boundaries and external dependencies for DreamLog Sleep Monitor, a Class A Sleep Tracking Display App. Reference IEC 62304 Clause 5.2.2.
Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

[Assistant] Content: The DreamLog Sleep Monitor system overview identifies all external entities interacting with the Sleep Tracking Display App: input sources (PPG sensor), output destinations (BLE 5.2), and the iOS/Android execution environment. Requirements for each external interface are documented in the interface requirements section.


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

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

"The RetinaScan Pro 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-SAFE-001: "fault response and safe shutdown" (Category: safety)
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 Cloud SaMD Histopathology Analysis Platform shall enter a defined safe state within the maximum allowable transition time when a critical fault is detected, ensuring no hazardous output persists.
Rationale: A deterministic safe-state transition prevents the Cloud SaMD Histopathology Analysis Platform from operating in an unknown or hazardous state after a detected fault.
Priority: Mandatory
Acceptance Criterion: Safe state transition completes within the specified time limit for each defined critical fault, verified by fault injection during operation.
Source: Risk control


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

[User]
Write a SDP section on development methodology for Class A for PowerTrack UPS Monitor, a Class A UPS Monitoring Software. Reference IEC 62304 Clause 5.1.1.
Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

[Assistant] Content: Development of the PowerTrack UPS Monitor uses an incremental build approach with three formal gates: requirements agreement, code complete, and release readiness. The Class A designation means verification focuses on system testing (Clause 5.7) and no separate architecture or unit verification phases are scheduled.


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

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

"Software requirements for the RetinaScan Pro are defined per Clause 5.2.1 and documented with the content required by Clause 5.2.2. Risk control measures are included in requirements per Clause 5.2.3. Requirements are verified per Clause 5.2.6."

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


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

[User]
Write a SDP section on risk control requirements traceability for AutoHUD Heads-Up Display Controller, a Class A Automotive HUD Controller Firmware. Reference IEC 62304 Clause 5.2.3.
Firmware rendering vehicle speed, navigation, and ADAS warnings on a windshield-projected heads-up display.

[Assistant] Content: Software-implemented risk controls for the AutoHUD Heads-Up Display Controller are documented as explicit requirements per Clause 5.2.3. Traceability from the ISO 14971 risk analysis through the SRS to verification test cases ensures that every risk control measure is implemented and verified in the Automotive HUD Controller Firmware.


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

[User]
Write a SDP section on risk control verification and traceability for SleepScore Apnea Screening Tool, a Class B Sleep Apnea Screening App. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Mobile app analyzing overnight audio recordings to screen for obstructive sleep apnea indicators. Screening only, not diagnostic.

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


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

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

"The CardioPulse Monitor addresses IEC 62304 Clause 4.4 for performance benchmarking and Clause 5.5.6 for detailed design verification."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 4.4 and 5.5.6, neither of which exists. Clause 4 only has 4.1, 4.2, 4.3. Clause 5.5 has 5.5.1 through 5.5.5 only. All clause references must be corrected.


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

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

"Statement coverage of 90% and branch coverage of 80% are mandatory for the BloodBank Manager."

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

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

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

[Assistant]
Verdict: PASS
Note: Content correctly limits Class A to system-level verification; limits verification to system testing per Clause 5.7. Standards references are accurate.


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

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

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

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


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

[User]
Write a SRS section on system boundaries and external dependencies for WoundTrack Healing Analyzer, a Class B Wound Assessment App. Reference IEC 62304 Clause 5.2.2.
Mobile app photographing wounds and measuring area/perimeter over time to track healing progress for clinician review.

[Assistant] Content: External dependencies of the WoundTrack Healing Analyzer include the Android operating environment, smartphone camera, and camera API. The Wound Assessment App requirements assume these dependencies operate within their specified parameters; failure modes of external components are addressed in the risk analysis.


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

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

"The RadView DICOM verification approach is commensurate with Class A risk. System tests validate end-to-end functionality. No formal code coverage metrics are required. The developer may self-verify test results."

[Assistant]
Verdict: PASS
Note: Content correctly limits Class A to system-level verification. 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 GlucoTrack CGM (continuous glucose monitor display, Class B):

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

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


[System] You are 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 BillingBridge Claims Processor, a Class A Claims Processing Service. Reference IEC 62304 Clause 5.7.4.
Backend service processing insurance claims from the hospital billing system. Financial processing only, no clinical data.

[Assistant] Content: Coverage analysis for the BillingBridge Claims Processor 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 Claims Processing Service 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 tool qualification for Class B and C for BalanceBoard Vestibular Trainer, a Class B Balance Training Platform Firmware. Reference IEC 62304 Clause 5.1.4.
Force plate firmware measuring center-of-pressure excursions during balance exercises. Provides real-time visual biofeedback.

[Assistant] Content: Verification tools for the BalanceBoard Vestibular Trainer Balance Training Platform Firmware are qualified per Clause 5.1.4. Qualification records document the tool name, version, intended use in the verification process, and evidence that the tool produces correct results. Tools whose output is not relied upon for verification decisions do not require qualification.


[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 GlucoSpot Continuous Glucose Display, a Class B CGM Display App. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Mobile app receiving and displaying continuous glucose monitor readings via BLE. Shows trends, time-in-range, and configurable glucose alerts.

[Assistant] Content: The GlucoSpot Continuous Glucose Display matrix traces two categories per Clause 5.7.1 and Clause 7.3.2: functional requirements (from system specification through design to test) and risk control requirements (from hazard analysis through SRS to verification). Both categories must show complete coverage before release of the CGM Display App.


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

[User]
Expand requirement SRS-DATA-001: "data retention period" (Category: data)
Project: RadView DICOM Viewer | Medical Image Viewer | Class A
Read-only display of medical images for reference viewing. Desktop application for viewing DICOM medical images. Display-only with standard windowing controls. No CAD or diagnostic measurement tools.

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 RadView DICOM Viewer shall retain measurement data in non-volatile storage for the specified minimum retention period, after which data may be overwritten.
Rationale: Data retention supports clinical trend analysis and regulatory requirements for record keeping associated with the Medical Image Viewer.
Priority: Mandatory
Acceptance Criterion: Retention period validation: records created at time T are still accessible at T + retention period.
Source: Regulatory


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

[User]
Expand requirement SRS-FUNC-004: "device configuration management" (Category: functional)
Project: GasMonitor Anesthetic Gas Logger | Anesthetic Gas Concentration Logger | Class A
Recording waste anesthetic gas levels for occupational safety documentation. Software logging waste anesthetic gas concentrations in operating rooms for occupational safety compliance. Recording only.

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

[Assistant]
Description: The GasMonitor Anesthetic Gas Logger shall allow authorized users to configure operating parameters via RS-232 and persist settings across power cycles.
Rationale: Parameter flexibility is essential for the Anesthetic Gas Concentration Logger to meet varying clinical requirements across deployment sites.
Priority: Mandatory
Acceptance Criterion: Configuration round-trip test: set, power-cycle, read-back for all parameters with 100% accuracy.
Source: User need


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

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

"The development plan references IEC 62304 Clause 5.7.6 and Clause 5.9 for the WoundTrack."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.7.6 and 5.9, neither of which exists. Clause 5.7 has 5.7.1 through 5.7.5 only. Clause 5 ends at 5.8. All clause 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 functional requirements overview for CardioRhythm ECG Analyzer, a Class B Single-Lead ECG Device Firmware. Reference IEC 62304 Clause 5.2.2.
Portable ECG device firmware acquiring single-lead ECG and classifying basic rhythm types. Incorrect classification could delay diagnosis.

[Assistant] Content: Functional requirements for the CardioRhythm ECG Analyzer specify the data processing, user interaction, and output generation capabilities of the Single-Lead ECG Device Firmware. Each requirement describes a discrete function the software shall perform during Acquisition and preliminary rhythm classification of single-lead ECG for clinical screening, with acceptance criteria sufficient to derive verification test cases.


[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 A with minimal documentation for LabStream LIS Middleware, a Class A Laboratory Information Middleware. Reference IEC 62304 Clause 5.1.1.
Middleware software connecting laboratory analyzers to the hospital LIS. Routes results, applies auto-validation rules, and flags critical values.

[Assistant] Content: This plan governs all software lifecycle activities for the LabStream LIS Middleware Laboratory Information Middleware from requirements analysis through release, per IEC 62304 Clause 5.1.1. The Class A classification permits a reduced documentation set: verification is performed solely at the system level (Clause 5.7), and no unit-level or integration-level verification activities are planned.


[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 milestones and phase transition criteria for AirSentry Urban Air Quality Station, a Class A Air Quality Monitoring Station Firmware. Reference IEC 62304 Clause 5.1.1.
IoT firmware for urban air quality monitoring stations measuring PM2.5, NO2, O3, and CO. Publishes data to public API.

[Assistant] Content: Transition between lifecycle phases requires completion of all phase-gate deliverables and sign-off by the designated reviewers. For the AirSentry Urban Air Quality Station 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 SRS section on requirements conventions and identification scheme for PressoTrack Blood Pressure Trending, a Class B Ambulatory Blood Pressure Monitor Firmware. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Firmware for an automated blood pressure cuff that trends readings over 24 hours. Trending errors could mask hypertensive episodes.

[Assistant] Content: Requirements for the PressoTrack Blood Pressure Trending Ambulatory Blood Pressure Monitor Firmware are documented per Clause 5.2.2 with clear acceptance criteria enabling direct derivation of test cases. Each requirement traces backward to its source and forward to its verification activity in the traceability matrix.


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

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

"Each BloodBank Manager software unit has a detailed design specification reviewed before implementation."

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

[User]
Write a SDP section on requirements elicitation and documentation for SterilLog Sterilization Record System, a Class A Sterilization Record Logger. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Software logging sterilization cycle parameters from autoclaves. Records temperature, pressure, and time for compliance documentation.

[Assistant] Content: Requirements for the SterilLog Sterilization Record System are elicited from system-level specifications, the ISO 14971 risk management file, and user needs analysis. Each software requirement is documented per Clause 5.2.2 with a unique identifier, rationale, acceptance criteria, and traceability to its source.


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

[User]
Review this documentation excerpt for the DialysisGuard (hemodialysis machine controller, Class C):

"Independent review is required for all Class C deliverables of the DialysisGuard. System verification is performed by personnel not directly responsible for the development of the item under review. Code reviews are conducted by qualified engineers who were not the original authors."

[Assistant]
Verdict: PASS
Note: Content correctly specifies full Class C rigor; correctly specifies independent review for Class C. Standards references are accurate.


[System] You are 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):

"Risk control verification for the ThermoGuard follows Clause 7.3. Each risk control measure implemented in software (Clause 7.2.2) has a corresponding verification activity. Traceability from hazard through control measure to verification is documented per Clause 7.3.2."

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


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

[User]
Write a SDP section on cybersecurity and health IT standards for PathSlide Digital Pathology Viewer, a Class A Digital Pathology Viewer. Reference IEC 62304 Clause 5.1.2.
Web viewer for whole-slide digital pathology images. Pan, zoom, and annotation display. No AI-assisted diagnosis.

[Assistant] Content: Security controls for the PathSlide Digital Pathology Viewer are derived from IEC 81001-5-1:2021, which mandates a security risk management process parallel to the ISO 14971 safety risk process. IEC 82304-1:2016 is applied where the Digital Pathology Viewer runs on general-purpose computing platforms outside the manufacturer's direct hardware 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 RetinaScan Pro (diabetic retinopathy screening AI, Class B):

"This plan is prepared in compliance with IEC 62304-5 and ISO 13485:2016."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304-5" which is incorrect. IEC 62304 has no Part 5. All references must be corrected.


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

[User]
Expand requirement SRS-PERF-001: "resource utilization limits" (Category: performance)
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: Peak memory consumption of the Linear Accelerator Control Software shall not exceed the allocated budget, with sufficient margin for stack overflow protection.
Rationale: Memory constraints are fixed by the VxWorks RTOS on PowerPC hardware and must be respected to prevent resource exhaustion during operation.
Priority: Mandatory
Acceptance Criterion: Memory profiling under stress conditions shows stable allocation with no leaks over a 72-hour test period.
Source: System requirement


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

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

"The development plan references IEC 62304 Clause 5.8.9 and Clause 5.0 for the LabView Portal."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.8.9 and 5.0, neither of which exists. Clause 5.8 has 5.8.1 through 5.8.8 only. Clause 5 starts at 5.1. All clause 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 functional requirements overview for PaceSet Pacemaker Programmer, a Class C Cardiac Pacemaker Programmer Software. Reference IEC 62304 Clause 5.2.2.
Desktop software for interrogating and programming cardiac pacemakers via telemetry wand. Incorrect programming could cause pacing failure.

[Assistant] Content: Functional requirements for the PaceSet Pacemaker Programmer are derived from the system requirements for Programming and interrogating implanted cardiac pacemakers including rate settings, sensitivity, and output parameters and from risk control measures identified in the ISO 14971 analysis. Each requirement specifies a single function of the Cardiac Pacemaker Programmer Software with measurable acceptance criteria.


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

[User]
Expand requirement SRS-PERF-001: "RAM and storage constraints" (Category: performance)
Project: CardioRhythm ECG Analyzer | Single-Lead ECG Device Firmware | Class B
Acquisition and preliminary rhythm classification of single-lead ECG for clinical screening. Portable ECG device firmware acquiring single-lead ECG and classifying basic rhythm types. Incorrect classification could delay diagnosis.

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

[Assistant]
Description: The CardioRhythm ECG Analyzer shall operate within the specified RAM and flash memory budget on the STM32L4+ platform, including all runtime allocations.
Rationale: Exceeding memory limits could cause undefined behavior in the Single-Lead ECG Device Firmware, potentially affecting safety.
Priority: Mandatory
Acceptance Criterion: Peak RAM usage during worst-case scenario does not exceed the specified limit, with minimum margin remaining.
Source: System requirement


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

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

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

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


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

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

"IEC 62304 Clause 5.10 requires the PhysioTrack Rehab to implement user acceptance testing."

[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 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 ChemoCalc (chemotherapy dose calculator, Class C):

"The ChemoCalc risk management file documents all identified hazards, estimated risks, implemented controls, and residual risk evaluations. Software-implemented controls are verified through targeted test cases. Verification records per Clause 7.3.3 confirm each control measure functions as intended."

[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 NurseCall Hub (patient call system dashboard, Class A):

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

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


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

[User]
Expand requirement SRS-PERF-001: "real-time performance requirement" (Category: performance)
Project: GrowthChart Pediatric Viewer | Growth Chart Display App | Class A
Visual display of pediatric growth measurements on standard percentile charts. Web app displaying pediatric growth charts with WHO/CDC percentile curves. Plots measurements, no diagnostic interpretation.

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 GrowthChart Pediatric Viewer shall process acquired data and update the output within the specified end-to-end latency from sample acquisition to display update.
Rationale: Real-time performance is critical for the Growth Chart Display App to support timely clinical decisions based on current data.
Priority: Mandatory
Acceptance Criterion: Worst-case latency measured under maximum load conditions does not exceed the specified absolute maximum.
Source: System requirement


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

[User]
Expand requirement SRS-FUNC-002: "alarm threshold management" (Category: functional)
Project: SleepScore Apnea Screening Tool | Sleep Apnea Screening App | Class B
Screening for sleep apnea indicators using smartphone audio analysis, requiring sleep study confirmation. Mobile app analyzing overnight audio recordings to screen for obstructive sleep apnea indicators. Screening only, not diagnostic.

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

[Assistant]
Description: The Sleep Apnea Screening App shall monitor all active parameters against user-configured thresholds and activate appropriate alarm signals when limits are breached.
Rationale: Timely alarm generation is essential for the Sleep Apnea Screening App to alert clinicians to abnormal conditions requiring intervention.
Priority: Mandatory
Acceptance Criterion: Alarm triggers within the specified response time of a threshold crossing, measured over 50 test crossings with no false negatives.
Source: Risk control


[System] You are a regulatory 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 milestones and phase transition criteria for PedDose Pediatric Dosing App, a Class B Pediatric Dosing Calculator App. Reference IEC 62304 Clause 5.1.1.
Mobile reference app for pediatric drug dosing with weight-based calculations and age-specific ranges.

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


[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-SAFE-002: "absence of safety-critical functions" (Category: safety)
Project: LabStream LIS Middleware | Laboratory Information Middleware | Class A
Routing and auto-validating laboratory results between analyzers and the laboratory information system. Middleware software connecting laboratory analyzers to the hospital LIS. Routes results, applies auto-validation rules, and flags critical values.

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 LabStream LIS Middleware software shall not implement any function that could directly control a therapeutic output, modify a diagnostic conclusion, or trigger a clinical alert, consistent with its Class A classification.
Rationale: The Class A classification of the Laboratory Information Middleware depends on the software having no path to contribute to a hazardous situation.
Priority: Mandatory
Acceptance Criterion: Code review confirms no software path exists that controls therapeutic outputs, modifies diagnostic results, or generates clinical alerts.
Source: Regulatory


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

[User]
Expand requirement SRS-INTF-001: "external system data exchange" (Category: interface)
Project: HandGrip Strength Dynamometer | Hand Dynamometer Firmware | Class B
Measuring hand grip strength and fatigue patterns for rehabilitation progress tracking. Digital hand dynamometer firmware measuring grip strength and fatigue over repeated trials for rehabilitation assessment.

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 HandGrip Strength Dynamometer shall exchange data with external systems via BLE 5.0 using the specified message format with error handling.
Rationale: External system connectivity is required for the Hand Dynamometer Firmware to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
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-DATA-002: "measurement data lifecycle" (Category: data)
Project: AuditTrail QMS Event Logger | QMS Audit Trail Service | Class A
Capturing and archiving QMS events for regulatory audit trails. Microservice capturing and storing quality management system audit events. Logging and reporting 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: Data retention in the AuditTrail QMS Event Logger shall meet the specified minimum duration, with oldest records overwritten only after the retention period expires.
Rationale: Regulatory compliance requires that measurement records be available for the specified retention period.
Priority: Mandatory
Acceptance Criterion: Oldest data record remains retrievable after continuous operation for the specified retention period.
Source: Regulatory


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

[User]
Expand requirement SRS-DATA-002: "record keeping duration" (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: Measurement records stored by the Neonatal Ventilator Firmware shall be maintained for the configured retention period before eligible for overwrite.
Rationale: Data retention supports clinical trend analysis and regulatory requirements for record keeping associated with the Neonatal Ventilator Firmware.
Priority: Mandatory
Acceptance Criterion: Retention period validation: records created at time T are still accessible at T + retention period.
Source: Regulatory


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

[User]
Write a SDP section on risk management integration into the lifecycle for WaveReview EEG Archive Viewer, a Class A EEG Archive Viewer. Reference IEC 62304 Clauses 7.1, 7.1.1.
Desktop application for reviewing archived EEG recordings. Playback and waveform display only, no seizure detection.

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


[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):

"The RadBeam Planner software development conforms to IEC 62304:2015, with risk management per ISO 14971:2019."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304:2015" which is incorrect. Wrong citation. Correct: IEC 62304:2006+AMD1:2015 (base standard from 2006, Amendment 1 in 2015). All references must be corrected.


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

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

"Compliance with IEC 62304 Clause 5.9 (operational qualification) and Clause 5.5.6 (post-market surveillance) is demonstrated."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.9 and 5.5.6, neither of which exists. Clause 5 ends at 5.8. Clause 5.5 has 5.5.1 through 5.5.5 only. All clause 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 FMEA section on risk control verification for PostureGuard Desk Monitor, a Class A Posture Wellness Display Software. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
USB webcam software that estimates sitting posture and displays a wellness score. No ergonomic prescriptions or clinical assessments.

[Assistant] Content: Risk control verification for the PostureGuard Desk Monitor per Clause 7.3.1 confirms that each control is correctly implemented and effective. Test cases exercise the control under normal and boundary conditions. Verification evidence per Clause 7.3.3 links the test result to the risk control measure and the originating hazard in the Posture Wellness Display Software risk management file.


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

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

"Configuration management follows industry best practices. All items are controlled as appropriate for the HydroLog development effort."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as appropriate", "best practices" provide no project-specific information about the HydroLog hydration tracking wellness app. 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 SRS section on data retention and integrity requirements for RadView DICOM Viewer, a Class A Medical Image Viewer. Reference IEC 62304 Clause 5.2.2.
Desktop application for viewing DICOM medical images. Display-only with standard windowing controls. No CAD or diagnostic measurement tools.

[Assistant] Content: The RadView DICOM Viewer Medical Image Viewer data requirements address storage, integrity, and lifecycle management. All persistent data is validated on read, and write operations use atomic commit mechanisms to prevent partial updates during Read-only display of medical images for reference viewing.


[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 PathCloud AI Histology Analyzer, a Class B Cloud SaMD Histopathology Analysis Platform. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Cloud-hosted SaMD analyzing whole-slide histology images with deep learning to flag suspicious regions for pathologist review. Runs as a multi-tenant SaaS.

[Assistant] Content: The PathCloud AI Histology Analyzer traceability matrix extends beyond functional requirements to include risk control traceability per Clause 7.3.2. Each risk control measure implemented in the Cloud SaMD Histopathology Analysis Platform software is traced from the ISO 14971 hazard through the software requirement to the verification test confirming its effectiveness.


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

[User]
Write a FMEA section on failure mode identification approach for GasMonitor Anesthetic Gas Logger, a Class A Anesthetic Gas Concentration Logger. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Software logging waste anesthetic gas concentrations in operating rooms for occupational safety compliance. Recording only.

[Assistant] Content: The GasMonitor Anesthetic Gas Logger failure mode identification per Clause 7.1.2 uses a function-by-function analysis of the Anesthetic Gas Concentration Logger. Each software function is examined for potential failure modes: omission, commission, early, late, and value errors. Potential causes per Clause 7.1.2 include design defects, SOUP anomalies per Clause 7.1.3, and environmental factors.


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

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

"The GlucoTrack CGM software development conforms to IEC 62304-2, with risk management per ISO 14971:2019."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304-2" which is incorrect. IEC 62304 has no Part 2. It is a single-part standard. 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):

"Maintenance activities follow ISO 14971:2020 Clause 6."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 14971:2020" which is incorrect. No 2020 edition. Current: ISO 14971:2019. All references must be corrected.


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

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

"The WoundTrack 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 an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-PERF-002: "real-time performance requirement" (Category: performance)
Project: PainRelief PCA Pump Controller | PCA Pump Controller Firmware | Class C
Patient-controlled analgesic delivery with lockout intervals and cumulative dose limits. Patient-controlled analgesia pump firmware allowing patient-initiated doses within physician-set limits. Overdose prevention is safety-critical.

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

[Assistant]
Description: End-to-end latency from syringe position encoder data acquisition to output presentation shall not exceed the specified limit under normal operating conditions.
Rationale: Bounded processing latency ensures the PCA Pump Controller Firmware provides readings reflecting the current state without clinically significant delay.
Priority: Mandatory
Acceptance Criterion: Worst-case latency measured under maximum load conditions does not exceed the specified absolute maximum.
Source: System requirement


[System] You are 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 integration plan defines incremental integration of all software units with interface testing at each step per Clause 5.6."

[Assistant]
Verdict: FAIL
Note: Content mandates integration testing with Clause 5.6 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 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 configuration management plan identifies all configuration items per Clause 8.1.1. SOUP items are tracked per Clause 8.1.2. Change control follows Clause 8.2 with traceability per Clause 8.2.4. Configuration status accounting is maintained per Clause 8.3."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the RetinaScan Pro (diabetic retinopathy screening AI, Class B). 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 AutoDose TPN (total parenteral nutrition calculator, Class C):

"Cybersecurity considerations are addressed as applicable to the total parenteral nutrition calculator. Controls are implemented following industry best practices and guidance."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "best practices", "as applicable" provide no project-specific information about the AutoDose TPN total parenteral nutrition calculator. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

[User]
Expand requirement SRS-FUNC-005: "display update rate for Patient Summary Dashboard" (Category: functional)
Project: VitalBoard Patient Summary | Patient Summary Dashboard | Class A
Read-only display of patient vital sign history for clinical reference. Dashboard displaying patient vital signs history retrieved from the EMR. View-only with no alerting or trend analysis.

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

[Assistant]
Description: Output presentation on the HL7 v2 ADT feed shall refresh at the configured interval, reflecting the most recent processed data from the Patient Summary Dashboard pipeline.
Rationale: Display freshness is critical for the Patient Summary Dashboard to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: End-to-end latency from data acquisition to display update does not exceed the specified limit for 99.9% of samples.
Source: User need


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

[User]
Write a SDP section on risk control requirements traceability for RoomBoard Digital Signage, a Class A Patient Room Digital Signage. Reference IEC 62304 Clause 5.2.3.
Hospital room digital signage displaying patient name, care team, and daily schedule. Display-only, no clinical data entry.

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


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

[User]
Write a SDP section on configuration identification approach for BeamPlan Radiation Treatment Planner, a Class C Radiation Treatment Planning Software. Reference IEC 62304 Clauses 8.1, 8.1.1.
Desktop software calculating radiation treatment plans including beam angles, dose distribution, and organ-at-risk constraints.

[Assistant] Content: Configuration items for the BeamPlan Radiation Treatment Planner Radiation Treatment Planning Software are identified and placed under version control per Clause 8.1. The configuration baseline includes all items needed to reproduce the released software: source code, build scripts, third-party libraries, and the documentation set.


[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 LinacControl Beam Delivery System, a Class C Linear Accelerator Control Software. Reference IEC 62304 Clause 7.1.1.
Software controlling linear accelerator beam delivery during radiation therapy. Beam-on errors could deliver lethal radiation doses.

[Assistant] Content: This comprehensive software FMEA for the LinacControl Beam Delivery System systematically analyzes all failure modes of the Linear Accelerator Control Software that could contribute to hazardous situations resulting in serious injury or death. The analysis covers ionization chamber (x2), position encoders data path integrity, processing algorithm correctness, output safety interlocks, and communication protocol failures.


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

[User]
Write a THREAT section on system description for threat modeling for FetalGuard Heart Rate Monitor, a Class B Fetal Heart Rate Monitor Firmware. Reference IEC 62304 Clause 5.2.1.
External fetal heart rate monitor firmware using Doppler ultrasound. Displays fetal heart rate and variability during labor.

[Assistant] Content: The FetalGuard Heart Rate Monitor threat model system description per IEC 81001-5-1:2021 identifies the Fetal Heart Rate Monitor Firmware as the subject, with trust boundaries at each external interface. Assets include software integrity, data confidentiality, and service availability during Continuous external fetal heart rate monitoring during labor with clinical display.


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

[User]
Review this documentation excerpt for the RadBeam Planner (radiation therapy planning system, Class C):

"Risk control measures are implemented per IEC 62311-1 Clause 7."

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


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

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

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

[User]
Write a SDP section on verification strategy for Class A -- system testing only for DoseLog Radiation Badge Reader, a Class A Dosimetry Data Logger. Reference IEC 62304 Clauses 5.7, 5.7.1.
Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

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


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

[User]
Write a SDP section on requirements verification approach for SunGuard UV Index Display, a Class A UV Exposure Display Firmware. Reference IEC 62304 Clause 5.2.6.
Wearable UV index monitor with an OLED display showing current UV exposure level. Informational only, no sunburn prevention claims.

[Assistant] Content: Requirements verification for the SunGuard UV Index Display is conducted per Clause 5.2.6 before the requirements baseline is established. The review confirms completeness, consistency, and testability. Any requirement failing these criteria is returned for rework before the UV Exposure Display Firmware proceeds to 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 VentAssist Pro (ICU ventilator controller, Class C):

"The software is released. The release is documented. The release is verified. The release package is prepared. The release is approved. The VentAssist Pro software release follows the process."

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


[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 TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

[Assistant] Content: Risk control coverage analysis for the TriageAI Emergency Triage Assistant 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 ED Triage Decision Support App.


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

[User]
Review this documentation excerpt for the MedInventory (medical supply tracking system, Class A):

"The MedInventory requires structural coverage analysis including decision coverage for all modules."

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

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

"The EchoAssist software development conforms to IEC 62304-2, with risk management per ISO 14971:2019."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304-2" which is incorrect. IEC 62304 has no Part 2. It is a single-part standard. 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 TRACE section on traceability scope including risk controls for RemotICU Continuous Monitoring Hub, a Class B Edge-to-Cloud ICU Monitoring Gateway. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Edge gateway collecting data from bedside monitors (SpO2, HR, BP, ventilator) and streaming to cloud for trending, alerting, and tele-ICU review.

[Assistant] Content: The RemotICU Continuous Monitoring Hub matrix traces two categories per Clause 5.7.1 and Clause 7.3.2: functional requirements (from system specification through design to test) and risk control requirements (from hazard analysis through SRS to verification). Both categories must show complete coverage before release of the Edge-to-Cloud ICU Monitoring Gateway.


[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):

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

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 14971:2020" which is incorrect. No 2020 edition. Current: ISO 14971:2019. All references must be corrected.


[System] You are a regulatory 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 external interface architecture for CardioCloud ECG Analysis Service, a Class B Cloud ECG Analysis SaMD. Reference IEC 62304 Clause 5.3.2.
Cloud SaaS platform receiving 12-lead ECG recordings from clinics, running automated arrhythmia detection, and returning annotated results via FHIR API.

[Assistant] Content: External interfaces of the CardioCloud ECG Analysis Service are architected as abstraction layers per Clause 5.3.2. The hardware interface, REST API protocol stack, and web portal are encapsulated behind defined APIs, enabling the Cloud ECG Analysis SaMD to be tested with simulated external components.


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

[User]
Review this documentation excerpt for the MedInventory (medical supply tracking system, Class A):

"The testing strategy includes unit testing of all modules, integration testing of interfaces, and system testing."

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


[System] You are a regulatory 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):

"Per IEC 62304, software safety classification is performed. Per IEC 62304, the safety class is determined. Per IEC 62304, the safety classification is documented. Per IEC 62304, the VentAssist Pro is classified per IEC 62304."

[Assistant]
Verdict: FAIL
Note: The documentation section exhibits repeated clause prefix. Multiple sentences begin with the same clause reference. Each sentence restates the same concept without adding information. Content should be consolidated and each sentence should contribute unique, specific information about the VentAssist Pro.


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

[User]
Write a SRS section on latency and throughput requirements for SurgiPlan 3D Surgical Planner, a Class B 3D Surgical Planning SaMD. Reference IEC 62304 Clause 5.2.2.
Desktop SaMD for orthopedic surgeons to plan joint replacement procedures on 3D CT reconstructions. Outputs implant sizing and positioning specifications.

[Assistant] Content: Performance requirements for the SurgiPlan 3D Surgical Planner specify maximum latencies, throughput rates, and resource consumption limits for the 3D Surgical Planning SaMD operating on Windows/macOS desktop with GPU. Latency requirements define the maximum time from input event to output response for each critical processing path during Preoperative 3D planning of joint replacement procedures with implant sizing and alignment.


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

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

"The PhysioTrack Rehab risk management file documents all identified hazards, estimated risks, implemented controls, and residual risk evaluations. Software-implemented controls are verified through targeted test cases. Verification records per Clause 7.3.3 confirm each control measure functions as intended."

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

"Risk control measures are implemented per IEC 62304-3 Clause 7."

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


[System] You are 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):

"Quality activities are performed in line with relevant standards and guidelines. Reviews and approvals follow established organizational procedures."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "relevant standards", "established organizational procedures" provide no project-specific information about the SleepWell sleep quality display app. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


[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-006: "output refresh interval for CalibrationTracker Equipment Logger" (Category: functional)
Project: CalibrationTracker Equipment Logger | Calibration Record System | Class A
Tracking calibration schedules and recording calibration results for compliance. Web application tracking calibration dates and results for medical test equipment. Administrative record keeping.

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 CalibrationTracker Equipment Logger display shall present current readings on REST API within the specified maximum update latency.
Rationale: Display freshness is critical for the Calibration Record System to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: End-to-end latency from data acquisition to display update does not exceed the specified limit for 99.9% of samples.
Source: User need


[System] You are 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):

"Maintenance planning for the PillRemind is established per Clause 6.1. Problem and modification analysis follows Clause 6.2. Modifications are implemented per Clause 6.3 using the established development processes."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the PillRemind (medication reminder app, Class A). 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 configuration identification approach for SleepScore Apnea Screening Tool, a Class B Sleep Apnea Screening App. Reference IEC 62304 Clauses 8.1, 8.1.1.
Mobile app analyzing overnight audio recordings to screen for obstructive sleep apnea indicators. Screening only, not diagnostic.

[Assistant] Content: Configuration items for the SleepScore Apnea Screening Tool Sleep Apnea Screening App are identified and placed under version control per Clause 8.1. The configuration baseline includes all items needed to reproduce the released software: source code, build scripts, third-party libraries, and the documentation set.


[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):

"Unit testing for the SleepWell shall achieve 90% statement coverage and 80% branch coverage."

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


[System] You are a regulatory 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):

"The ArthroNav Class C 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 full Class C rigor; limits verification to system testing per Clause 5.7. 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-PERF-001: "RAM and storage constraints" (Category: performance)
Project: LabView Results Portal | Laboratory Results Viewer | Class A
Read-only display of laboratory test results for clinician reference. Web application displaying laboratory test results retrieved from the hospital LIS. Read-only viewer with no result interpretation or flagging.

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 LabView Results Portal memory footprint on Web SPA shall remain within specified limits under worst-case operational scenarios.
Rationale: Memory constraints are fixed by the Web SPA hardware and must be respected to prevent resource exhaustion during operation.
Priority: Mandatory
Acceptance Criterion: Memory profiling under stress conditions shows stable allocation with no leaks over a 72-hour test period.
Source: System requirement


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

[User]
Review this documentation excerpt for the NeuroStim Programmer (neurostimulator programmer, Class C):

"Maintenance activities follow ISO 14971:2020 Clause 6."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 14971:2020" which is incorrect. No 2020 edition. Current: ISO 14971:2019. All references must be corrected.


[System] You are a regulatory 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 hazard identification for the specific device for HemaCount Digital Cell Counter, a Class B IVD Digital Cell Counter Software. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Desktop software performing automated differential white blood cell counting on digitized blood smear images using computer vision.

[Assistant] Content: The HemaCount Digital Cell Counter risk analysis per Clause 7.1.2 identifies software causes of hazardous situations specific to the IVD Digital Cell Counter Software: 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 SRS section on operational context and user population for DoseCalc Medication Calculator, a Class B Medication Dose Calculator App. Reference IEC 62304 Clause 5.2.2.
Mobile app calculating medication doses based on patient weight, age, and renal function. Incorrect calculations could cause underdosing or adverse effects.

[Assistant] Content: The DoseCalc Medication Calculator operates as a Medication Dose Calculator App where Calculating weight-based medication doses for clinical prescribing support. The software interfaces with external data sources and communicates via manual data entry, FHIR Patient API. The operational environment, user population, and regulatory context described here constrain the requirements that follow.