[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):

"Static analysis using MISRA C rules is mandatory for all HydroLog source files. Unit testing with MC/DC coverage is required for safety-critical paths."

[Assistant]
Verdict: FAIL
Note: Content mandates MISRA C static analysis and MC/DC unit testing for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). MISRA C and MC/DC coverage targets are Class C considerations, 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 RadView DICOM (DICOM image viewer, Class A):

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

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the RadView DICOM (DICOM image viewer, 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 PaceSet Pacemaker Programmer, a Class C Cardiac Pacemaker Programmer Software. Reference IEC 62304 Clauses 8.1, 8.1.1.
Desktop software for interrogating and programming cardiac pacemakers via telemetry wand. Incorrect programming could cause pacing failure.

[Assistant] Content: Configuration items for the PaceSet Pacemaker Programmer Cardiac Pacemaker Programmer 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 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 C -- unit, integration, and system with coverage for BreathSync ICU Ventilator Controller, a Class C ICU Ventilator Controller Software. Reference IEC 62304 Clauses 5.5, 5.5.2, 5.6, 5.7.
Software controlling an ICU mechanical ventilator with multiple ventilation modes (volume, pressure, SIMV). Failure could result in patient death.

[Assistant] Content: The BreathSync ICU Ventilator Controller verification strategy spans three levels: unit testing (Clause 5.5), integration testing (Clause 5.6), and system testing (Clause 5.7). Unit tests target statement coverage >= 90%, branch coverage >= 80%, and MC/DC coverage >= 80% for all safety-critical units of the ICU Ventilator Controller Software. Independent reviewers verify test completeness and coverage adequacy at each level.


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

[User] Can I cite ISO 13485-1 in my documentation?

[Assistant] No. ISO 13485 is a single-part standard. There is no ISO 13485-1. The correct citation is ISO 13485:2016.


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

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

"Software safety classification is performed per IEC 62304-3 Clause 4.3."

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


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

[User]
Write a TRACE section on purpose and scope of the traceability matrix for PhysioTrack Rehabilitation Monitor, a Class B Physical Therapy Tracking System. Reference IEC 62304 Clause 5.7.1.
Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

[Assistant] Content: The PhysioTrack Rehabilitation Monitor traceability matrix provides end-to-end requirement coverage evidence per Clause 5.7.1. Every SRS requirement for the Physical Therapy Tracking System is traced to its implementing software item and to the verification test case(s) confirming correct implementation. Orphaned requirements and untested implementations are flagged for resolution.


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

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

"The StepTrack shall undergo static code analysis with all warnings treated as errors, followed by unit testing with decision coverage of at least 75%."

[Assistant]
Verdict: FAIL
Note: Content mandates static analysis and unit testing with decision coverage for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Unit verification (Clause 5.5) and static analysis requirements are not mandated for Class A.


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

[User]
Write a SRS section on data format and interoperability requirements for RenalDose Renal Adjustment Calculator, a Class B Renal Dose Adjustment Calculator. Reference IEC 62304 Clause 5.2.2.
Calculator adjusting medication doses for patients with impaired renal function based on eGFR.

[Assistant] Content: The RenalDose Renal Adjustment Calculator Renal Dose Adjustment Calculator data exchange formats are specified in this SRS with field-level definitions, data types, units, and valid ranges. The software performs schema validation on all incoming data from manual input before processing.


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

[User]
Expand requirement SRS-PERF-002: "resource utilization limits" (Category: performance)
Project: WaterPure Quality Logger | Water Quality Data Logger | Class A
Continuous logging of purified water parameters for GMP compliance. Embedded system logging purified water system parameters (conductivity, TOC, flow rate) for pharmaceutical manufacturing compliance.

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

[Assistant]
Description: The WaterPure Quality Logger shall operate within the specified RAM and flash memory budget on the PLC with HMI platform, including all runtime allocations.
Rationale: Memory constraints are fixed by the PLC with HMI hardware and must be respected to prevent resource exhaustion during operation.
Priority: Mandatory
Acceptance Criterion: Peak RAM usage during worst-case scenario does not exceed the specified limit, with minimum margin remaining.
Source: System requirement


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

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

[Assistant] Content: User interaction requirements for the GaitSense Walking Analysis define the input mechanisms, display elements, and feedback provided by the Gait Analysis Insole Firmware during Quantitative gait analysis using instrumented insoles for orthopedic and rehabilitation assessment. Requirements specify the information presented to the user, the actions available, and the system response to each user action.


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

[User]
Write a SDP section on system test execution and acceptance for Class A for VisitorPass Access Management, a Class A Visitor Management System. Reference IEC 62304 Clauses 5.7, 5.7.4.
Kiosk application for visitor registration and badge printing in hospital lobbies. Administrative access control.

[Assistant] Content: The VisitorPass Access Management system test suite runs on Windows kiosk exercising all functional, performance, and interface requirements. Clause 5.7.4 verification confirms every SRS requirement has at least one passing system test. Unit-level verification (Clause 5.5) and integration testing (Clause 5.6) are outside the scope of Class A verification and are not executed.


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

[User]
Write a SRS section on latency and throughput requirements for RetinaScan Diabetic Retinopathy Screener, a Class B Retinal Screening Software. Reference IEC 62304 Clause 5.2.2.
Desktop software analyzing retinal fundus images to detect signs of diabetic retinopathy for ophthalmologist review.

[Assistant] Content: The RetinaScan Diabetic Retinopathy Screener performance requirements define measurable bounds on processing latency, data throughput, and memory utilization. The Retinal Screening Software must sustain these performance levels under peak operating conditions on Windows desktop with GPU throughout the full duration of AI-assisted screening of retinal images for diabetic retinopathy signs, requiring specialist confirmation.


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

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

"An independent verification and validation (IV&V) team reviews all StepTrack development artifacts and test results before release approval."

[Assistant]
Verdict: FAIL
Note: Content mandates independent verification and validation (IV&V) for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Independent verification 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 FMEA section on risk control verification for WaveReview EEG Archive Viewer, a Class A EEG Archive Viewer. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Desktop application for reviewing archived EEG recordings. Playback and waveform display only, no seizure detection.

[Assistant] Content: The WaveReview EEG Archive Viewer risk control verification per Clause 7.3.1 exercises each control measure in isolation and in the context of the complete EEG Archive Viewer. Clause 7.3.3 documentation records the verification method, the test result, and the conclusion regarding the control's effectiveness.


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

[User]
Expand requirement SRS-INTF-001: "primary sensor interface protocol" (Category: interface)
Project: VibeCheck Vibration Analyzer | Vibration Analysis Instrument Firmware | Class A
Vibration spectrum analysis of industrial machinery for predictive maintenance. Portable vibration analysis firmware for predictive maintenance of industrial rotating machinery. FFT analysis of accelerometer data.

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 Vibration Analysis Instrument Firmware sensor interface shall establish and maintain reliable communication with the IEPE accelerometer (100 mV/g) via BNC input.
Rationale: Reliable sensor communication is the foundation of the Vibration Analysis Instrument Firmware data acquisition pipeline.
Priority: Mandatory
Acceptance Criterion: Communication operates without data loss for 72 hours continuously, with automatic recovery from simulated failures within the specified time.
Source: System requirement


[System] You are 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):

"Compliance with IEC 62304 Clause 5.7.6 is demonstrated through post-market surveillance."

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


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

[User]
Write a TRACE section on purpose and scope of the traceability matrix for HumidityMap Room Condition Logger, a Class A Environmental Condition Logger. Reference IEC 62304 Clause 5.7.1.
Network of IoT sensors logging temperature and humidity across hospital storage areas. Dashboard display for facility management.

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


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

[User]
Write a SDP section on minimal deliverables list for Class A for AllergyCard Patient Allergy Viewer, a Class A Patient Allergy Display. Reference IEC 62304 Clause 5.1.8.
Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

[Assistant] Content: Required documentation deliverables for the Class A AllergyCard Patient Allergy Viewer are: this Software Development Plan, the Software Requirements Specification, the System Test Plan and Report, the Software Release Record, and the Risk Management File summary. Detailed design documentation, unit test reports, and integration test reports are not required for Class A and are not produced.


[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):

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

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


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

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

"The StepTrack software verification plan specifies system testing as the sole verification activity. Clause 5.5 (unit verification) and Clause 5.6 (integration testing) do not apply to Class A. Test cases verify all software requirements."

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


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

[User]
Expand requirement SRS-PERF-002: "measurement accuracy specification" (Category: performance)
Project: TriageAI Emergency Triage Assistant | ED Triage Decision Support App | Class B
Assisting emergency nurses with triage acuity scoring based on patient assessment data. Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

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 accuracy of the ED Triage Decision Support App shall meet or exceed the specified tolerance for all measurement parameters across operating conditions.
Rationale: Inaccurate output from the ED Triage Decision Support App could lead to incorrect clinical actions, making accuracy a safety-critical requirement.
Priority: Mandatory
Acceptance Criterion: Statistical analysis of 500 measurements shows mean error within tolerance and standard deviation within specified limits.
Source: Regulatory


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

[User]
Expand requirement SRS-INTF-002: "data export and interoperability" (Category: interface)
Project: SurgLog Procedure Documentation App | Surgical Documentation App | Class A
Documentation and review of surgical procedure notes. Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

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 Surgical Documentation App shall support bidirectional data exchange with external systems over REST API.
Rationale: External system connectivity is required for the Surgical Documentation App 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. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SRS section on latency and throughput requirements for RadOnco Cloud Treatment Planner, a Class C Cloud Radiation Treatment Planning SaMD. Reference IEC 62304 Clause 5.2.2.
Cloud-based radiation oncology treatment planning system using GPU clusters for Monte Carlo dose calculation. Treatment plans directly drive linear accelerator delivery.

[Assistant] Content: Performance requirements for the RadOnco Cloud Treatment Planner specify maximum latencies, throughput rates, and resource consumption limits for the Cloud Radiation Treatment Planning SaMD operating on AWS p4d GPU instances + EKS + CloudFront. Latency requirements define the maximum time from input event to output response for each critical processing path during Cloud-based Monte Carlo dose calculation and treatment plan optimization for radiation oncology.


[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 CardioCloud ECG Analysis Service, a Class B Cloud ECG Analysis SaMD. Reference IEC 62304 Clause 5.7.4.
Cloud SaaS platform receiving 12-lead ECG recordings from clinics, running automated arrhythmia detection, and returning annotated results via FHIR API.

[Assistant] Content: Coverage analysis for the CardioCloud ECG Analysis Service 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 Cloud ECG Analysis SaMD release is contingent on 100% requirement coverage with no open gaps.


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

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

"The BloodBank Manager integration test suite validates all APIs, shared memory interfaces, and IPC mechanisms between software items."

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


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

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

"The StepTrack detailed design describes algorithms, data structures, and internal interfaces for each unit."

[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 verification approach for ConsentView Informed Consent Archive, a Class A Consent Document Viewer. Reference IEC 62304 Clause 5.2.6.
Web portal for patients and staff to view signed informed consent documents. Read-only document viewer.

[Assistant] Content: Verification of ConsentView Informed Consent Archive software requirements follows Clause 5.2.6. Reviewers confirm that every requirement is complete, consistent, testable, and traceable. Requirements that implement risk controls are additionally verified against the ISO 14971 risk management file for the Consent Document Viewer.


[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: "initialization integrity checks" (Category: functional)
Project: AllergyCard Patient Allergy Viewer | Patient Allergy Display | Class A
Read-only display of patient allergy information at point of care. Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

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

[Assistant]
Description: Upon power-up, the AllergyCard Patient Allergy Viewer shall execute a self-test sequence verifying the integrity of the primary sensor interface, internal memory, and output subsystem before entering operational mode.
Rationale: Startup verification prevents the Patient Allergy Display from operating with undetected faults that could affect output accuracy.
Priority: Mandatory
Acceptance Criterion: Self-test completes within the specified startup time and correctly detects each of the following injected faults: sensor disconnection, memory corruption, and display failure.
Source: System requirement


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

[User]
Expand requirement SRS-FUNC-005: "primary sensor data capture and buffering" (Category: functional)
Project: AnticoagCalc INR Dose Adjuster | Anticoagulation Dosing Support Tool | Class B
Suggesting warfarin dose adjustments based on INR values for physician review. Web tool suggesting warfarin dose adjustments based on INR readings and patient history. Clinical decision support requiring physician review.

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

[Assistant]
Description: The AnticoagCalc INR Dose Adjuster shall continuously sample primary sensor data, buffer readings in memory, and pass validated samples to the processing module without data loss.
Rationale: Continuous data acquisition from the primary sensor is the fundamental input for Suggesting warfarin dose adjustments based on INR values for physician review.
Priority: Mandatory
Acceptance Criterion: Verified by test: software acquires sensor data continuously for 60 minutes without data loss, confirmed by comparing acquisition count against expected count at the configured sampling rate.
Source: System requirement


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

[User]
Write a FMEA section on risk control verification for PowerTrack UPS Monitor, a Class A UPS Monitoring Software. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

[Assistant] Content: Risk control verification for the PowerTrack UPS 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 UPS Monitoring 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 FetaSound (fetal heart rate monitor, Class B):

"REQ-SRS-078: The FetaSound 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 an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on requirements verification approach for AIDose Chemotherapy Decision Support, a Class C Cloud AI Chemotherapy Dosing SaMD. Reference IEC 62304 Clause 5.2.6.
Cloud SaMD providing AI-driven chemotherapy dosing recommendations based on patient genomics, lab values, and treatment response data.

[Assistant] Content: Requirements verification for the AIDose Chemotherapy Decision Support 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 Cloud AI Chemotherapy Dosing SaMD proceeds to design.


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

[User]
Expand requirement SRS-PERF-003: "end-to-end processing latency" (Category: performance)
Project: BrachyDose HDR Afterloader Controller | HDR Brachytherapy Afterloader Firmware | Class C
Controlling radioactive source stepping positions and dwell times for high-dose-rate brachytherapy. Firmware controlling high-dose-rate brachytherapy source positioning and dwell times. Source positioning errors cause lethal local radiation.

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: Processing latency of the HDR Brachytherapy Afterloader Firmware shall be bounded to ensure timely output that reflects current input conditions.
Rationale: Bounded processing latency ensures the HDR Brachytherapy Afterloader 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 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 CardioCloud ECG Analysis Service, a Class B Cloud ECG Analysis SaMD. Reference IEC 62304 Clause 5.2.2.
Cloud SaaS platform receiving 12-lead ECG recordings from clinics, running automated arrhythmia detection, and returning annotated results via FHIR API.

[Assistant] Content: The CardioCloud ECG Analysis Service Cloud ECG Analysis SaMD is deployed in an environment where Automated arrhythmia detection and ECG interpretation as a cloud service for remote clinics. Users include trained clinical staff and, where applicable, patients or caregivers. The GCP Kubernetes (GPU node pool) platform defines the computational environment, while REST API provides the primary data communication pathway.


[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 PulmoCheck Spirometry Analyzer, a Class B Spirometry Analysis Software. Reference IEC 62304 Clause 5.2.1.
Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

[Assistant] Content: Threat modeling for the PulmoCheck Spirometry Analyzer begins with a system description identifying entry points, data stores, and trust boundaries of the Spirometry Analysis Software. The model covers the Windows desktop execution environment, all USB, desktop GUI interfaces, and persistent data stores.


[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 architecture verification scope for SurgiPlan 3D Surgical Planner, a Class B 3D Surgical Planning SaMD. Reference IEC 62304 Clauses 5.3.1, 5.3.6.
Desktop SaMD for orthopedic surgeons to plan joint replacement procedures on 3D CT reconstructions. Outputs implant sizing and positioning specifications.

[Assistant] Content: The architecture described in this document is verified per Clause 5.3.6, confirming that all software requirements are addressed by at least one software item. Verification also confirms that the SurgiPlan 3D Surgical Planner 3D Surgical Planning SaMD architecture supports the defined interfaces and does not introduce new hazards.


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

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

"The ThermoGuard addresses IEC 62304 Clause 5.9 for post-market surveillance and Clause 4.5 for operational qualification."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.9 and 4.5, neither of which exists. Clause 5 ends at 5.8. Clause 4 only has 4.1, 4.2, 4.3. 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 SDP section on cybersecurity and health IT standards for PharmLog Medication History Viewer, a Class A Medication History Viewer. Reference IEC 62304 Clause 5.1.2.
Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

[Assistant] Content: Security controls for the PharmLog Medication History 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 Medication History 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 HeartLink (cardiac telemetry system, Class B):

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

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


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

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

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

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


[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: PhysioTrack Rehabilitation Monitor | Physical Therapy Tracking System | Class B
Tracking exercise performance and range of motion during physical therapy for therapist review. Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

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 Physical Therapy Tracking System 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 Physical Therapy Tracking System.
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-SEC-002: "cryptographic data security" (Category: security)
Project: RadOnco Cloud Treatment Planner | Cloud Radiation Treatment Planning SaMD | Class C
Cloud-based Monte Carlo dose calculation and treatment plan optimization for radiation oncology. Cloud-based radiation oncology treatment planning system using GPU clusters for Monte Carlo dose calculation. Treatment plans directly drive linear accelerator delivery.

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

[Assistant]
Description: All stored patient data in the Cloud Radiation Treatment Planning SaMD shall be protected by AES-256 or equivalent encryption, with keys managed per established cryptographic practices.
Rationale: Encryption of stored patient data protects against unauthorized disclosure if the Cloud Radiation Treatment Planning SaMD storage media is accessed outside the intended context.
Priority: Mandatory
Acceptance Criterion: Cryptographic implementation validated against NIST standards with no known vulnerabilities in the selected algorithm.
Source: Regulatory


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

[User]
Write a SAD section on data paths and processing pipeline for NutriCalc TPN Formulation Tool, a Class B TPN Formulation Calculator. Reference IEC 62304 Clauses 5.3.1, 5.3.2.
Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

[Assistant] Content: Data within the NutriCalc TPN Formulation Tool TPN Formulation Calculator traverses three processing stages: acquisition, analysis, and presentation. Each stage is implemented as an independent software item with typed interfaces per Clause 5.3.2. The architecture ensures data integrity is verifiable at each stage boundary during integration testing.


[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 addresses IEC 62304 Clause 4.4 for performance benchmarking and Clause 5.5.2.1 for detailed design verification."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 4.4 and 5.5.2.1, neither of which exists. Clause 4 only has 4.1, 4.2, 4.3. IEC 62304 has no four-level numbering. 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 ArthroNav (surgical navigation system, Class C):

"Cybersecurity considerations are addressed as applicable to the surgical navigation system. 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 ArthroNav surgical navigation system. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

[User]
Write a SDP section on change control process for RemotICU Continuous Monitoring Hub, a Class B Edge-to-Cloud ICU Monitoring Gateway. Reference IEC 62304 Clauses 8.2, 8.2.1.
Edge gateway collecting data from bedside monitors (SpO2, HR, BP, ventilator) and streaming to cloud for trending, alerting, and tele-ICU review.

[Assistant] Content: No change to the RemotICU Continuous Monitoring Hub baseline is implemented without an approved change request per Clause 8.2. The approval process evaluates the change's impact on safety, regulatory compliance, and previously verified functionality. Post-implementation verification confirms the change was correctly applied per Clause 8.2.3.


[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):

"This plan is prepared in compliance with IEC 62304:2022 and ISO 13485:2016."

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


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

[User]
Review this documentation excerpt for the HeartLink (cardiac telemetry system, Class B):

"The software shall be developed in accordance with best practices and applicable standards. Development activities will be performed as appropriate for the project scope."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as appropriate", "best practices", "applicable standards" provide no project-specific information about the HeartLink cardiac telemetry system. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

[User] What is the difference between Class B and Class C verification?

[Assistant]
The key differences in verification between Class B and Class C:

**Class B:**
- Integration testing: required
- Unit testing: recommended but not mandatory
- No specific coverage targets mandated
- Developer or QA may perform verification

**Class C:**
- Unit testing: mandatory with coverage targets
  - Statement coverage ≥ 90%
  - Branch coverage ≥ 80%
  - MC/DC coverage ≥ 80%
- Integration testing: required
- Independent review: verification must be performed by personnel not involved in development
- Detailed design documentation (Clause 5.4): required for every software unit


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

[User]
Write a SAD section on SOUP component integration and requirements for RadOnco Cloud Treatment Planner, a Class C Cloud Radiation Treatment Planning SaMD. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Cloud-based radiation oncology treatment planning system using GPU clusters for Monte Carlo dose calculation. Treatment plans directly drive linear accelerator delivery.

[Assistant] Content: SOUP integration in the RadOnco Cloud Treatment Planner architecture follows Clause 5.3.3 and Clause 5.3.4. Each SOUP item has documented functional requirements, performance requirements, and platform dependencies. The Cloud Radiation Treatment Planning SaMD architecture ensures SOUP components are isolated behind defined interfaces to limit the impact of SOUP defects.


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

[User]
Expand requirement SRS-FUNC-001: "audit trail and data export" (Category: functional)
Project: DialyFlow Dialysis Fluid Controller | Hemodialysis Fluid Controller Firmware | Class C
Controlling dialysate composition, flow rates, and ultrafiltration in hemodialysis. Firmware controlling dialysate flow rates and composition in a hemodialysis machine. Fluid balance errors could be fatal.

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 Hemodialysis Fluid Controller Firmware shall maintain a timestamped record of all measurements in non-volatile storage, supporting export via CAN bus.
Rationale: Persistent measurement records enable post-hoc analysis and meet regulatory requirements for data retention.
Priority: Desirable
Acceptance Criterion: Data retrieval produces complete, uncorrupted records for the full specified retention period.
Source: User need


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

[User]
Write a SDP section on internal SOPs and procedures for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clause 5.1.2.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: Company-internal standard operating procedures supplement the international standards for the CochleaMap CI Fitting Software project. SOP-010 through SOP-013 address development planning, risk management, configuration management, and verification planning. All SOPs are part of the ISO 13485 quality management system and are binding on the Cochlear Implant Fitting Software development team.


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

[User]
Write a FMEA section on risk control measures and implementation for AllergyCard Patient Allergy Viewer, a Class A Patient Allergy Display. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

[Assistant] Content: Risk control measures for the AllergyCard Patient Allergy Viewer are defined per Clause 7.2.1 and implemented in software per Clause 7.2.2. Controls include input validation for data inputs, range checking on processed values, and timeout detection on HL7 FHIR AllergyIntolerance API. Each control is traced to a software requirement and verified through testing.


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

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

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

[User]
Write a SDP section on cybersecurity and health IT standards for DermaLens Teledermatology Platform, a Class B Cloud Teledermatology SaMD. Reference IEC 62304 Clause 5.1.2.
Cloud platform enabling dermatologists to review patient-submitted skin images with AI-assisted triage scoring. Images uploaded from mobile app to cloud pipeline.

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


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

[User]
Write a SRS section on data processing and transformation requirements for ScheduleSync Appointment Manager, a Class A Appointment Scheduling System. Reference IEC 62304 Clause 5.2.2.
Web application for scheduling patient appointments across multiple clinics. Administrative scheduling only, no clinical workflow.

[Assistant] Content: Data processing requirements for the ScheduleSync Appointment Manager define the transformations applied to raw input from data sources to produce the output presented to the user. Each transformation has defined accuracy bounds and error handling behavior specific to the Appointment Scheduling System operational context.


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

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

"The software is released. The release is documented. The release is verified. The release package is prepared. The release is approved. The ChemoCalc 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 ChemoCalc.


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

[User]
Write a SDP section on purpose and scope for Class A with minimal documentation for OBDView Diagnostic Display, a Class A Vehicle Diagnostic Display App. Reference IEC 62304 Clause 5.1.1.
Mobile app connecting to vehicle OBD-II port to display engine parameters, fault codes, and emissions data.

[Assistant] Content: This Software Development Plan establishes the lifecycle framework for the OBDView Diagnostic Display Vehicle Diagnostic Display App, defining all development activities, deliverables, and verification milestones in compliance with IEC 62304 Clause 5.1.1. As a Class A system that cannot contribute to a hazardous situation, the documentation scope is intentionally minimal, focusing on system-level verification and requirements traceability rather than detailed design or unit-level testing.


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

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

"The NurseCall Hub integration test plan covers all inter-module interfaces per Clause 5.6."

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


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

[User]
Expand requirement SRS-FUNC-005: "audit trail and data export" (Category: functional)
Project: FleetTrack GPS Tracking Module | Fleet GPS Tracking Firmware | Class A
Real-time GPS tracking and geofence monitoring of fleet vehicles. Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

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

[Assistant]
Description: All processed measurements shall be stored with timestamps in a persistent log accessible through LTE-M cellular for clinical review and regulatory audit.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Fleet GPS Tracking Firmware.
Priority: Desirable
Acceptance Criterion: Data retrieval produces complete, uncorrupted records for the full specified retention period.
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 NurseCall Hub (patient call system dashboard, Class A):

"Unit verification per IEC 62304 Clause 5.5 requires testing of all NurseCall Hub software units."

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


[System] You are 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 gap identification and coverage analysis for FridgeGuard Temperature Logger, a Class A Cold Chain Temperature Logger. Reference IEC 62304 Clause 5.7.4.
Firmware logging refrigerator temperatures for vaccine and medication cold chain compliance. Records and displays data, no alerts that drive clinical decisions.

[Assistant] Content: Coverage analysis for the FridgeGuard Temperature Logger 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 Cold Chain Temperature Logger release is contingent on 100% requirement coverage with no open gaps.


[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: "output refresh interval for AirSentry Urban Air Quality Station" (Category: functional)
Project: AirSentry Urban Air Quality Station | Air Quality Monitoring Station Firmware | Class A
Continuous measurement and public reporting of urban air quality parameters. IoT firmware for urban air quality monitoring stations measuring PM2.5, NO2, O3, and CO. Publishes data to public API.

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

[Assistant]
Description: Output presentation on the 4G LTE shall refresh at the configured interval, reflecting the most recent processed data from the Air Quality Monitoring Station Firmware pipeline.
Rationale: Timely display updates ensure the user observes current readings without perceiving lag.
Priority: Mandatory
Acceptance Criterion: Measured display update interval is within 10% of the specified refresh period across 100 consecutive update cycles.
Source: User need


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

[User]
Write a SRS section on sensor and communication protocol requirements for NutriView Food Diary, a Class A Nutritional Tracking Display App. Reference IEC 62304 Clause 5.2.2.
Mobile app for manual food logging with nutritional summary display. No dietary recommendations or medical nutrition therapy.

[Assistant] Content: The NutriView Food Diary communication interfaces include REST API, camera for barcode scan connecting the Nutritional Tracking Display App to external systems and sensors. Each interface requirement specifies the expected behavior under normal operation and the response to communication failure conditions.


[System] You are an IEC 62304 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: CleanRoom Particle Counter Logger | Cleanroom Environmental Logger | Class A
Logging and displaying airborne particle counts for cleanroom compliance. Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

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

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


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

[User]
Write a SDP section on risk control requirements traceability for TempWatch Body Temperature Logger, a Class A Temperature Logging Firmware. Reference IEC 62304 Clause 5.2.3.
Firmware for a wearable temperature patch that logs skin temperature over 24 hours and displays trends. No fever detection or alerts.

[Assistant] Content: Software-implemented risk controls for the TempWatch Body Temperature Logger 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 Temperature Logging Firmware.


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

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

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

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


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

[User]
Write a TRACE section on risk control coverage verification for SupplyChain Procurement Portal, a Class A Supply Chain Procurement System. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Web portal for ordering medical supplies with approval workflows. Procurement and logistics only.

[Assistant] Content: The SupplyChain Procurement Portal risk control gap analysis verifies end-to-end traceability per Clause 7.3.2: from hazard to risk control to software requirement to test case to test result. Gaps at any point in this chain prevent release of the Supply Chain Procurement System until resolved. The analysis is documented as part of the Release Readiness Review evidence.


[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):

"Verification activities follow IEC 62304 Clause 5.3.7 for continuous monitoring."

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


[System] You are a regulatory 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):

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

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


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

[User]
Write a SDP section on risk management integration into the lifecycle for PulmoCheck Spirometry Analyzer, a Class B Spirometry Analysis Software. Reference IEC 62304 Clauses 7.1, 7.1.1.
Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

[Assistant] Content: Software risk management activities are integrated throughout the PulmoCheck Spirometry Analyzer development lifecycle in accordance with IEC 62304 Clause 7 and ISO 14971. Risk analysis begins during requirements analysis, with identified hazards traced through design, implementation, and verification to confirm that all risk control measures are effectively implemented and verified.


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

[User]
Expand requirement SRS-INTF-001: "primary sensor interface protocol" (Category: interface)
Project: TempWatch Body Temperature Logger | Temperature Logging Firmware | Class A
Passive logging and display of skin temperature trends for personal interest. Firmware for a wearable temperature patch that logs skin temperature over 24 hours and displays trends. No fever detection or alerts.

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

[Assistant]
Description: Communication with the MAX30208 temperature sensor over I2C shall include CRC-based error detection, automatic retry, and graceful degradation on persistent failure.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Temperature Logging Firmware output.
Priority: Mandatory
Acceptance Criterion: Error injection tests confirm 100% detection rate for corrupted frames and recovery within specified timeout.
Source: System requirement


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

[User]
Write a SAD section on external interface architecture for AnticoagCalc INR Dose Adjuster, a Class B Anticoagulation Dosing Support Tool. Reference IEC 62304 Clause 5.3.2.
Web tool suggesting warfarin dose adjustments based on INR readings and patient history. Clinical decision support requiring physician review.

[Assistant] Content: The AnticoagCalc INR Dose Adjuster architecture isolates external dependencies behind abstraction interfaces per Clause 5.3.2. The FHIR Observation API and web form communication interfaces are accessed through adapter modules that translate protocol-specific details into the internal data model of the Anticoagulation Dosing Support Tool.


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

[User]
Expand requirement SRS-INTF-002: "sensor data link requirements" (Category: interface)
Project: DermaLens Teledermatology Platform | Cloud Teledermatology SaMD | Class B
AI-assisted triage scoring of skin lesion images submitted through a mobile teledermatology workflow. Cloud platform enabling dermatologists to review patient-submitted skin images with AI-assisted triage scoring. Images uploaded from mobile app to cloud pipeline.

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

[Assistant]
Description: The DermaLens Teledermatology Platform shall communicate with the smartphone camera (via mobile app) via REST API, implementing error detection and recovery for communication failures.
Rationale: Reliable sensor communication is the foundation of the Cloud Teledermatology SaMD data acquisition pipeline.
Priority: Mandatory
Acceptance Criterion: Error injection tests confirm 100% detection rate for corrupted frames and recovery within specified timeout.
Source: System requirement


[System] You are a regulatory 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 CleanRoom Particle Counter Logger, a Class A Cleanroom Environmental Logger. Reference IEC 62304 Clause 5.2.2.
Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

[Assistant] Content: The CleanRoom Particle Counter Logger Cleanroom Environmental Logger is deployed in an environment where Logging and displaying airborne particle counts for cleanroom compliance. Users include trained clinical staff and, where applicable, patients or caregivers. The Linux (Raspberry Pi) platform defines the computational environment, while RS-485 Modbus provides the primary data communication pathway.


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

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

"The SleepWell software verification plan specifies system testing as the sole verification activity. Clause 5.5 (unit verification) and Clause 5.6 (integration testing) do not apply to Class A. Test cases verify all software requirements."

[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 CaloriePal (nutrition tracking app, Class A):

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

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


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

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


[System] You are 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):

"Verification of the MedInventory is scoped to system testing. The medical supply tracking system cannot contribute to a hazardous situation, so minimal verification consisting of system tests against requirements is sufficient per IEC 62304."

[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-FUNC-004: "configuration persistence and validation" (Category: functional)
Project: PainScale Digital Assessment Tool | Pain Assessment Tool | Class B
Standardized pain intensity and quality assessment with longitudinal tracking for treatment evaluation. Web app for standardized pain assessment using validated scales (VAS, NRS, McGill). Records longitudinal pain data for treatment monitoring.

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

[Assistant]
Description: Configuration changes to the PainScale Digital Assessment Tool shall be validated against allowed ranges before acceptance and persisted to survive power loss.
Rationale: Configurable parameters allow the Pain Assessment Tool to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: All configurable parameters persist correctly across power cycles and reject out-of-range values with appropriate error messages.
Source: User need


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

[User]
Write a SDP section on internal SOPs and procedures for GlucoSpot Continuous Glucose Display, a Class B CGM Display App. Reference IEC 62304 Clause 5.1.2.
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 development team follows company SOPs aligned with ISO 13485:2016 quality management requirements: SOP-010 governs software planning, SOP-012 governs configuration management, and SOP-013 governs verification. Each SOP is version-controlled and reviewed annually to maintain compliance.


[System] You are 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 architectural overview for Class B for RespiRate Respiratory Monitor, a Class B Respiratory Rate Monitor Firmware. Reference IEC 62304 Clauses 5.3.1, 5.3.2.
Wearable firmware monitoring respiratory rate via chest impedance. Displays rate and alerts on bradypnea/tachypnea.

[Assistant] Content: Architectural design of the RespiRate Respiratory Monitor uses a modular decomposition that separates input handling, business logic, and output generation. Each module has a defined interface per Clause 5.3.2. The Respiratory Rate Monitor Firmware architecture on nRF52840 facilitates integration testing at module boundaries.


[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: "BIS module data capture and buffering" (Category: functional)
Project: AnesBot Automated Anesthesia Controller | Automated Anesthesia Delivery Software | Class C
Target-controlled propofol infusion guided by processed EEG depth-of-anesthesia monitoring. Software controlling target-controlled infusion of propofol based on BIS monitoring. Overdose could cause respiratory arrest.

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 AnesBot Automated Anesthesia Controller software shall acquire BIS module data at the specified sampling rate and store values in a circular buffer for processing by the Automated Anesthesia Delivery Software signal pipeline.
Rationale: Reliable sensor data capture underpins all downstream processing and clinical output of the Automated Anesthesia Delivery Software.
Priority: Mandatory
Acceptance Criterion: Verified by test: software acquires sensor data continuously for 60 minutes without data loss, confirmed by comparing acquisition count against expected count at the configured sampling rate.
Source: System requirement


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

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the WoundTrack (wound measurement imaging system, Class B). Standards references are accurate.


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

[User]
Expand requirement SRS-FUNC-003: "device configuration management" (Category: functional)
Project: AssetTrack Equipment Inventory | Equipment Inventory System | Class A
Tracking location and status of medical equipment for inventory management. Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management 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: Operating parameters of the Equipment Inventory System shall be user-configurable within validated ranges and stored in non-volatile memory.
Rationale: Configurable parameters allow the Equipment Inventory System to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: All configurable parameters persist correctly across power cycles and reject out-of-range values with appropriate error messages.
Source: User need


[System] You are an IEC 62304 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 Class B verification includes integration testing per Clause 5.6 and system testing per Clause 5.7. Integration tests verify inter-module interfaces. Statement coverage of at least 80% is targeted for unit tests where performed. The development team performs verification activities."

[Assistant]
Verdict: PASS
Note: Content correctly specifies Class B requirements. 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: "data retention period" (Category: data)
Project: AutoHUD Heads-Up Display Controller | Automotive HUD Controller Firmware | Class A
Rendering critical driving information on a windshield heads-up display. Firmware rendering vehicle speed, navigation, and ADAS warnings on a windshield-projected heads-up display.

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

[Assistant]
Description: Measurement records stored by the Automotive HUD Controller 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 Automotive HUD Controller Firmware.
Priority: Mandatory
Acceptance Criterion: Oldest data record remains retrievable after continuous operation for the specified retention period.
Source: Regulatory


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

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

"In accordance with ISO 14971:2020, verification activities include system testing."

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


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

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

"Software safety classification is performed per ISO 14971:2020 Clause 4.3."

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

[User]
Expand requirement SRS-INTF-002: "primary sensor communication specification" (Category: interface)
Project: IncidentReport Clinical Event Logger | Incident Reporting System | Class A
Submission and routing of clinical incident reports for quality review. Web form for staff to submit clinical incident reports. Data entry and routing only, no analysis.

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

[Assistant]
Description: Communication with the primary sensor over REST API shall include CRC-based error detection, automatic retry, and graceful degradation on persistent failure.
Rationale: Reliable sensor communication is the foundation of the Incident Reporting System data acquisition pipeline.
Priority: Mandatory
Acceptance Criterion: Communication operates without data loss for 72 hours continuously, with automatic recovery from simulated failures within the specified time.
Source: System requirement


[System] You are 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 minimal deliverables list for Class A for NutriView Food Diary, a Class A Nutritional Tracking Display App. Reference IEC 62304 Clause 5.1.8.
Mobile app for manual food logging with nutritional summary display. No dietary recommendations or medical nutrition therapy.

[Assistant] Content: The NutriView Food Diary Class A documentation plan produces five controlled documents: this SDP, the Software Requirements Specification, the System Test Plan and Report, the Software Release Record, and the Risk Management File. No additional verification documents are required for the Nutritional Tracking Display 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 HeartLink (cardiac telemetry system, Class B):

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

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


[System] You are 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):

"Independent review is required for all Class C deliverables of the AutoDose TPN. 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 an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-INTF-001: "primary sensor interface protocol" (Category: interface)
Project: CochleaMap CI Fitting Software | Cochlear Implant Fitting Software | Class C
Programming electrode mapping and stimulation parameters for cochlear implant sound processors. Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

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 CochleaMap CI Fitting Software shall communicate with the electrode impedance measurement via USB programming cable, implementing error detection and recovery for communication failures.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Cochlear Implant Fitting Software output.
Priority: Mandatory
Acceptance Criterion: Communication operates without data loss for 72 hours continuously, with automatic recovery from simulated failures within the specified time.
Source: System requirement