[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 BreathEasy Air Quality Display, a Class A Environmental Air Quality Display. Reference IEC 62304 Clause 5.2.2.
Indoor air quality monitor displaying PM2.5, CO2, and temperature on an LCD. Informational display only with no clinical guidance.

[Assistant] Content: The BreathEasy Air Quality Display performance requirements define measurable bounds on processing latency, data throughput, and memory utilization. The Environmental Air Quality Display must sustain these performance levels under peak operating conditions on ESP32-S3 throughout the full duration of Informational display of indoor air quality metrics for general awareness.


[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: "output precision and accuracy" (Category: performance)
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: Output accuracy of the Anticoagulation Dosing Support Tool shall meet or exceed the specified tolerance for all measurement parameters across operating conditions.
Rationale: Measurement accuracy directly affects clinical decisions based on the Anticoagulation Dosing Support Tool output and is a key factor in the risk profile.
Priority: Mandatory
Acceptance Criterion: Accuracy verified against a calibrated reference across the full measurement range, with all readings within tolerance for 200+ test points.
Source: Regulatory


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

[User]
Write a SRS section on data processing and transformation requirements for VitalBoard Patient Summary, a Class A Patient Summary Dashboard. Reference IEC 62304 Clause 5.2.2.
Dashboard displaying patient vital signs history retrieved from the EMR. View-only with no alerting or trend analysis.

[Assistant] Content: Processing requirements for the VitalBoard Patient Summary Patient Summary Dashboard cover data acquisition, filtering, computation, and presentation. Each processing step has specified input ranges, output tolerances, and error conditions. Data integrity is maintained throughout the processing pipeline.


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

[User] List all valid IEC 62304 sub-clauses under Clause 7.2 and their subjects.

[Assistant]
IEC 62304 Clause 7.2 (Risk control measures) contains the following sub-clauses:

- Clause 7.2: Risk control measures
- Clause 7.2.1: Define risk control measures
- Clause 7.2.2: Risk control measures implemented in software

These are the only valid sub-clauses under 7.2. No additional sub-clauses exist.


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

[User]
Write a SRS section on sensor and communication protocol requirements for PathSlide Digital Pathology Viewer, a Class A Digital Pathology Viewer. Reference IEC 62304 Clause 5.2.2.
Web viewer for whole-slide digital pathology images. Pan, zoom, and annotation display. No AI-assisted diagnosis.

[Assistant] Content: External interface requirements for the PathSlide Digital Pathology Viewer Digital Pathology Viewer define the data exchanged across each interface boundary: REST API, WebSocket tile streaming. For each interface, requirements specify the protocol, data format, timing, and error recovery behavior.


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

[User]
Expand requirement SRS-PERF-003: "RAM and storage constraints" (Category: performance)
Project: PathCloud AI Histology Analyzer | Cloud SaMD Histopathology Analysis Platform | Class B
AI-assisted identification of suspicious regions in digitized histology slides for pathologist review. Cloud-hosted SaMD analyzing whole-slide histology images with deep learning to flag suspicious regions for pathologist review. Runs as a multi-tenant SaaS.

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

[Assistant]
Description: The PathCloud AI Histology Analyzer memory footprint on AWS ECS (GPU instances) + React SPA shall remain within specified limits under worst-case operational scenarios.
Rationale: Exceeding memory limits could cause undefined behavior in the Cloud SaMD Histopathology Analysis Platform, potentially affecting safety.
Priority: Mandatory
Acceptance Criterion: Memory profiling under stress conditions shows stable allocation with no leaks over a 72-hour test period.
Source: System requirement


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

[User]
Write a THREAT section on system description for threat modeling for BreathSync ICU Ventilator Controller, a Class C ICU Ventilator Controller Software. Reference IEC 62304 Clause 5.2.1.
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 threat model scope encompasses the ICU Ventilator Controller Software, its communication interfaces (solenoid valve drivers, blower motor PWM, touchscreen HMI), stored data, and the operational environment. Data flows between the differential pressure flow sensor and the application logic, and between the application and HL7 to EMR are analyzed for potential security threats.


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

[User]
Expand requirement SRS-PERF-001: "data processing timing constraint" (Category: performance)
Project: LabStream LIS Middleware | Laboratory Information Middleware | Class A
Routing and auto-validating laboratory results between analyzers and the laboratory information system. Middleware software connecting laboratory analyzers to the hospital LIS. Routes results, applies auto-validation rules, and flags critical values.

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

[Assistant]
Description: Processing latency of the Laboratory Information Middleware shall be bounded to ensure timely output that reflects current input conditions.
Rationale: Real-time performance is critical for the Laboratory Information Middleware to support timely clinical decisions based on current data.
Priority: Mandatory
Acceptance Criterion: Worst-case latency measured under maximum load conditions does not exceed the specified absolute maximum.
Source: System requirement


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

[User]
Expand requirement SRS-PERF-002: "real-time performance requirement" (Category: performance)
Project: ClinTrial EDC Platform | Clinical Trial EDC Web Platform | Class A
Electronic capture and management of clinical trial data across multiple investigator sites. Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

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

[Assistant]
Description: End-to-end latency from primary sensor data acquisition to output presentation shall not exceed the specified limit under normal operating conditions.
Rationale: Real-time performance is critical for the Clinical Trial EDC Web Platform to support timely clinical decisions based on current data.
Priority: Mandatory
Acceptance Criterion: End-to-end latency is within the specified limit for 99.9% of samples over a 24-hour test period.
Source: System requirement


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

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

"Per IEC 62304 Clause 7.1, risk analysis is performed. Per IEC 62304 Clause 7.1, hazards are identified. Per IEC 62304 Clause 7.1, causes are documented. Per IEC 62304 Clause 7.1, the StepTrack risk analysis is complete."

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


[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 MedRef Clinical Reference App, a Class A Clinical Drug Reference App. Reference IEC 62304 Clause 5.2.2.
Standalone mobile app providing searchable drug reference database with interaction checker. Display-only — no prescription or dosing decisions.

[Assistant] Content: The MedRef Clinical Reference App Clinical Drug Reference App data exchange formats are specified in this SRS with field-level definitions, data types, units, and valid ranges. The software performs schema validation on all incoming data from REST API for DB sync before processing.


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

[User]
Write a TRACE section on risk control coverage verification for BreathEasy Air Quality Display, a Class A Environmental Air Quality Display. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Indoor air quality monitor displaying PM2.5, CO2, and temperature on an LCD. Informational display only with no clinical guidance.

[Assistant] Content: The BreathEasy Air Quality Display gap analysis per Clause 5.7.4 and Clause 7.3.2 verifies that the risk control traceability chain is complete. Every hazard in the risk management file that has a software control must trace to a verified requirement in the Environmental Air Quality Display. Incomplete chains are flagged and resolved before release.


[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 primary international standards applicable to development for PathSlide Digital Pathology Viewer, a Class A Digital Pathology Viewer. Reference IEC 62304 Clause 5.1.2.
Web viewer for whole-slide digital pathology images. Pan, zoom, and annotation display. No AI-assisted diagnosis.

[Assistant] Content: The software lifecycle for the PathSlide Digital Pathology Viewer is executed under IEC 62304:2006+AMD1:2015, with risk management per ISO 14971:2019 integrated at each phase gate. Quality system requirements follow ISO 13485:2016, and usability validation of the Digital Pathology Viewer follows IEC 62366-1:2015+AMD1:2020.


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

[User]
Review this documentation excerpt for the FetaSound (fetal heart rate monitor, Class B):

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

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


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

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

"IEC 62304:2022 Section 6.1 requires all software units to be verified."

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

[User]
Write a SRS section on functional requirements overview for PathCloud AI Histology Analyzer, a Class B Cloud SaMD Histopathology Analysis Platform. Reference IEC 62304 Clause 5.2.2.
Cloud-hosted SaMD analyzing whole-slide histology images with deep learning to flag suspicious regions for pathologist review. Runs as a multi-tenant SaaS.

[Assistant] Content: Functional requirements for the PathCloud AI Histology Analyzer specify the data processing, user interaction, and output generation capabilities of the Cloud SaMD Histopathology Analysis Platform. Each requirement describes a discrete function the software shall perform during AI-assisted identification of suspicious regions in digitized histology slides for pathologist review, with acceptance criteria sufficient to derive verification test cases.


[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: PainRelief PCA Pump Controller | PCA Pump Controller Firmware | Class C
Patient-controlled analgesic delivery with lockout intervals and cumulative dose limits. Patient-controlled analgesia pump firmware allowing patient-initiated doses within physician-set limits. Overdose prevention is safety-critical.

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

[Assistant]
Description: The PainRelief PCA Pump Controller shall exchange data with external systems via motor driver using the specified message format with error handling.
Rationale: Interoperability enables integration of PCA Pump Controller Firmware data into the clinical workflow and patient record.
Priority: Desirable
Acceptance Criterion: Format validation passes for all message types with correct field encoding verified.
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 scope boundaries of the software system for PharmLog Medication History Viewer, a Class A Medication History Viewer. Reference IEC 62304 Clauses 5.1.1, 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: This plan applies to all software executing within the PharmLog Medication History Viewer Medication History Viewer and its supporting build and verification infrastructure. External systems that exchange data with the Medication History Viewer via FHIR MedicationDispense API are covered only at the interface boundary; their internal implementation is outside the scope of this SDP.


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

[User]
Write a SRS section on system boundaries and external dependencies for StepSync Activity Tracker, a Class A Wellness Activity Display App. Reference IEC 62304 Clause 5.2.2.
Mobile app displaying daily step count, distance, and calories from a wrist-worn accelerometer. Read-only display with no clinical interpretation.

[Assistant] Content: The StepSync Activity Tracker software boundary encompasses the Wellness Activity Display App application executing on iOS/Android. External dependencies include 3-axis accelerometer hardware and REST API. These external systems are treated as black boxes at the software boundary, with interface requirements specified in this SRS.


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

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


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

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

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

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


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

[User]
Write a FMEA section on risk control measures and implementation for BreathSync ICU Ventilator Controller, a Class C ICU Ventilator Controller Software. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
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 risk controls per Clause 7.2.1 address each failure mode with unacceptable residual risk. Software-implemented controls per Clause 7.2.2 include defensive coding measures, plausibility checks, and safe-state transitions. Each control is documented as a software requirement and verified for the ICU Ventilator Controller Software.


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

[User]
Expand requirement SRS-FUNC-002: "data logging and retrieval" (Category: functional)
Project: SterilLog Sterilization Record System | Sterilization Record Logger | Class A
Recording and archiving sterilization cycle parameters for regulatory compliance. Software logging sterilization cycle parameters from autoclaves. Records temperature, pressure, and time for compliance documentation.

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

[Assistant]
Description: The SterilLog Sterilization Record System shall log measurement data with timestamps to non-volatile storage and provide a mechanism to retrieve logged data via RS-232.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Sterilization Record Logger.
Priority: Desirable
Acceptance Criterion: Logged data is retrievable after power cycle, with all timestamps accurate to within 1 second of the reference clock.
Source: User need


[System] You are 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 C with segregation for NeuroTune DBS Programmer, a Class C Deep Brain Stimulator Programmer App. Reference IEC 62304 Clauses 5.3.1, 5.3.2, 5.3.5.
Tablet application programming deep brain stimulation implants for movement disorders. Stimulation parameter errors could cause neurological harm.

[Assistant] Content: The NeuroTune DBS Programmer Deep Brain Stimulator Programmer App architecture implements segregation per Clause 5.3.5 to isolate safety-critical software items from non-safety items. The safety-critical path -- from NFC/BLE telemetry acquisition through processing to safety output -- is architecturally independent from auxiliary functions. This segregation supports the Class C verification strategy including independent review.


[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 system boundaries and external dependencies 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: External dependencies of the NutriView Food Diary include the iOS/Android operating environment, input hardware, and REST API. The Nutritional Tracking Display App requirements assume these dependencies operate within their specified parameters; failure modes of external components are addressed in the risk analysis.


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

[User]
Expand requirement SRS-FUNC-006: "data logging and retrieval" (Category: functional)
Project: NutriView Food Diary | Nutritional Tracking Display App | Class A
Personal food logging and nutritional data visualization. Mobile app for manual food logging with nutritional summary display. No dietary recommendations or medical nutrition therapy.

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 Nutritional Tracking Display App shall maintain a timestamped record of all measurements in non-volatile storage, supporting export via REST API.
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 an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on scope boundaries of the software system for FallRisk Inpatient Assessment Tool, a Class B Fall Risk Assessment App. Reference IEC 62304 Clauses 5.1.1, 5.1.2.
Web app calculating fall risk scores for inpatients based on mobility, medication, and cognitive assessments.

[Assistant] Content: Scope is limited to the FallRisk Inpatient Assessment Tool software items developed under this plan and released as a single configuration baseline. Peripherals, test jigs, and cloud infrastructure used during Calculating fall risk scores for hospitalized patients to guide nursing interventions are addressed by separate system-level documentation and are not governed by IEC 62304 Clause 5.1.1 activities described herein.


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

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

"In accordance with IEC 62304-2, verification activities include system testing."

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


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

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

"Verification of the NurseCall Hub consists exclusively of system-level testing per IEC 62304 Clause 5.7. Test cases derive from the software requirements specification and execute against the patient call system dashboard in its target environment. Unit-level and integration testing are not required for Class A and are not performed."

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


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

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

[Assistant] Content: External interface requirements for the GrowthChart Pediatric Viewer Growth Chart Display App define the data exchanged across each interface boundary: FHIR Observation API. For each interface, requirements specify the protocol, data format, timing, and error recovery behavior.


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

[User]
Write a SDP section on hazard identification for the specific device for SunGuard UV Index Display, a Class A UV Exposure Display Firmware. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Wearable UV index monitor with an OLED display showing current UV exposure level. Informational only, no sunburn prevention claims.

[Assistant] Content: The SunGuard UV Index Display risk analysis per Clause 7.1.2 identifies software causes of hazardous situations specific to the UV Exposure Display Firmware: data path corruption, timing violations, resource exhaustion, and incorrect state transitions. Each cause is linked to a risk control measure per Clause 7.2.1 and implemented as a verifiable software requirement.


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

[User]
Write a SAD section on external interface architecture for ChestAI Pulmonary Nodule Detector, a Class B AI Pulmonary Nodule Detection SaMD. Reference IEC 62304 Clause 5.3.2.
Cloud AI SaMD analyzing chest CT scans to detect and measure pulmonary nodules, providing CAD overlay for radiologist review. FDA De Novo pathway.

[Assistant] Content: The ChestAI Pulmonary Nodule Detector uses adapter patterns for all external interfaces: DICOMweb, REST API, structured report SR output. Each adapter implements a common internal interface per Clause 5.3.2, isolating the AI Pulmonary Nodule Detection SaMD processing logic from external protocol details.


[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):

"Integration testing for the CardioPulse Monitor covers all interfaces between software items per Clause 5.6.1 through 5.6.7. Test content addresses data flow, timing, and error handling at each interface. Regression testing is conducted per Clause 5.6.6 after each integration step."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the CardioPulse Monitor (cardiac rhythm monitor, Class B). Standards references are accurate.


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

[User]
Write a THREAT section on threat model data flow decomposition for PulseRing Smart Ring Monitor, a Class B Wearable Smart Ring Firmware + Companion App. Reference IEC 62304 Clause 5.2.2.
Wearable smart ring firmware measuring continuous PPG for heart rate and SpO2 with BLE streaming to companion mobile app for trend display.

[Assistant] Content: The PulseRing Smart Ring Monitor data flow diagrams for threat analysis map all data movement within and across the Wearable Smart Ring Firmware + Companion App boundary. Trust boundaries are placed at external interfaces (BLE 5.3, companion iOS/Android app), persistent storage, and inter-process communication points.


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

[User]
Write a SDP section on development methodology for Class A for CalibrationTracker Equipment Logger, a Class A Calibration Record System. Reference IEC 62304 Clause 5.1.1.
Web application tracking calibration dates and results for medical test equipment. Administrative record keeping.

[Assistant] Content: A streamlined iterative model governs the CalibrationTracker Equipment Logger development. Given the Class A classification, the lifecycle omits formal architecture verification and detailed design phases, proceeding directly from requirements to implementation and then to system-level verification of the Calibration Record System on Web SPA.


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

[User]
Write a SRS section on external system communication requirements for AnesBot Automated Anesthesia Controller, a Class C Automated Anesthesia Delivery Software. Reference IEC 62304 Clause 5.2.2.
Software controlling target-controlled infusion of propofol based on BIS monitoring. Overdose could cause respiratory arrest.

[Assistant] Content: External communication requirements for the AnesBot Automated Anesthesia Controller define the data exchange with systems outside the device boundary via touchscreen. Requirements cover connection establishment, data transfer, error detection, and graceful degradation when the external system is unreachable during Target-controlled propofol infusion guided by processed EEG depth-of-anesthesia monitoring.


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

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

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

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


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

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

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

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


[System] You are 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 verification strategy mandates unit testing with 90% statement coverage, integration testing of all component interfaces, and system-level testing."

[Assistant]
Verdict: FAIL
Note: Content mandates unit testing and integration testing for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Unit verification (Clause 5.5) and integration testing (Clause 5.6) are not required for Class A.


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

[User]
Write a SRS section on purpose of the SRS document for GlucoSpot Continuous Glucose Display, a Class B CGM Display App. Reference IEC 62304 Clause 5.2.1.
Mobile app receiving and displaying continuous glucose monitor readings via BLE. Shows trends, time-in-range, and configurable glucose alerts.

[Assistant] Content: The purpose of this SRS is to establish the complete set of software requirements for the GlucoSpot Continuous Glucose Display, providing the basis for design, implementation, and verification of the CGM Display App. Requirements are organized by type and traced to their originating system requirement, risk control measure, or stakeholder need per Clause 5.2.1.


[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):

"Code reviews by personnel independent of the development team are mandatory for all changes."

[Assistant]
Verdict: FAIL
Note: Content mandates independent review for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Independent review is required only for Class C (Clause 5.5.4, 5.7.4).


[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 test records and acceptance criteria for Class B for ChestAI Pulmonary Nodule Detector, a Class B AI Pulmonary Nodule Detection SaMD. Reference IEC 62304 Clauses 5.6.7, 5.7.5.
Cloud AI SaMD analyzing chest CT scans to detect and measure pulmonary nodules, providing CAD overlay for radiologist review. FDA De Novo pathway.

[Assistant] Content: Acceptance of the ChestAI Pulmonary Nodule Detector AI Pulmonary Nodule Detection SaMD requires documented evidence of successful integration testing (recorded per Clause 5.6.7) and system testing (recorded per Clause 5.7.5). Regression testing per Clause 5.6.6 is performed after each change to the integration baseline to confirm no previously verified behavior has been affected.


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

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

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

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


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

[User]
Review this documentation excerpt for the CaloriePal (nutrition tracking app, Class A):

"The lifecycle processes for the CaloriePal comply with IEC 62304-6."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304-6" which is incorrect. IEC 62304 has no Part 6. All references must be corrected.


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

[User]
Write a SRS section on resource constraints and scalability for PressoTrack Blood Pressure Trending, a Class B Ambulatory Blood Pressure Monitor Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware for an automated blood pressure cuff that trends readings over 24 hours. Trending errors could mask hypertensive episodes.

[Assistant] Content: Computational resource requirements for the PressoTrack Blood Pressure Trending define the maximum CPU utilization, RAM consumption, and flash/disk usage permitted on Nordic nRF5340. The Ambulatory Blood Pressure Monitor Firmware must meet all functional and timing requirements within these resource envelopes.


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

[User]
Write a SAD section on SOUP component integration and requirements for TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

[Assistant] Content: Third-party software components used in the TriageAI Emergency Triage Assistant are documented per Clause 5.3.3, including functional and performance requirements imposed on each SOUP item. Hardware and software dependencies per Clause 5.3.4 are recorded to ensure that the iPad web app environment satisfies all SOUP prerequisites.


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

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

[Assistant] Content: Threat model decomposition for the GlucoEdge Continuous Glucose Platform uses data flow diagrams at two levels of detail: a context diagram showing the Hybrid CGM Edge-Cloud Platform and all external entities, and a level-1 diagram showing internal processes and data stores. Each data flow crossing a trust boundary is subject to STRIDE analysis.


[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 RadView DICOM Viewer, a Class A Medical Image Viewer. Reference IEC 62304 Clause 5.1.2.
Desktop application for viewing DICOM medical images. Display-only with standard windowing controls. No CAD or diagnostic measurement tools.

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

[User]
Review this documentation excerpt for the DermaScan AI (skin lesion classifier, Class B):

"Problem resolution is established for the DermaScan AI. Problems are reported. Problems are investigated. Problems are resolved. Problems are tracked. Problem resolution follows IEC 62304 Clause 9."

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


[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-007: "measurement data archival" (Category: functional)
Project: ClinTrial EDC Platform | Clinical Trial EDC Web Platform | Class A
Electronic capture and management of clinical trial data across multiple investigator sites. Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

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

[Assistant]
Description: The Clinical Trial EDC Web Platform shall maintain a timestamped record of all measurements in non-volatile storage, supporting export via REST API.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Clinical Trial EDC Web Platform.
Priority: Desirable
Acceptance Criterion: Data retrieval produces complete, uncorrupted records for the full specified retention period.
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 BloodBank Manager (blood bank inventory system, Class A):

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

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


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

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

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

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the PacePilot (pacemaker programmer, Class C). Standards references are accurate.


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

[User]
Write a SRS section on functional requirements overview for SurgLog Procedure Documentation App, a Class A Surgical Documentation App. Reference IEC 62304 Clause 5.2.2.
Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

[Assistant] Content: This section specifies the functional behavior of the SurgLog Procedure Documentation App Surgical Documentation App. Requirements cover data input from tablet microphone, processing algorithms, output generation via REST API, and user interaction patterns. All functional requirements are derived from the system specification or risk analysis.


[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 WaterPure Quality Logger, a Class A Water Quality Data Logger. Reference IEC 62304 Clause 5.1.8.
Embedded system logging purified water system parameters (conductivity, TOC, flow rate) for pharmaceutical manufacturing compliance.

[Assistant] Content: The WaterPure Quality Logger documentation set is limited to the deliverables required for Class A: the SDP, SRS, system test records, software release record, and the risk management file. No architecture document, detailed design specification, unit test report, or integration test report is produced for this Water Quality Data Logger.


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

[User]
Write a SDP section on purpose and scope for Class A with minimal documentation for CalibrationTracker Equipment Logger, a Class A Calibration Record System. Reference IEC 62304 Clause 5.1.1.
Web application tracking calibration dates and results for medical test equipment. Administrative record keeping.

[Assistant] Content: This Software Development Plan establishes the lifecycle framework for the CalibrationTracker Equipment Logger Calibration Record System, 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 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 DialyFlow Dialysis Fluid Controller, a Class C Hemodialysis Fluid Controller Firmware. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Firmware controlling dialysate flow rates and composition in a hemodialysis machine. Fluid balance errors could be fatal.

[Assistant] Content: Risk control verification for the DialyFlow Dialysis Fluid Controller 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 Hemodialysis Fluid Controller Firmware risk management file.


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

[User]
Write a FMEA section on risk control measures and implementation for FleetTrack GPS Tracking Module, a Class A Fleet GPS Tracking Firmware. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

[Assistant] Content: Each risk control for the FleetTrack GPS Tracking Module per Clause 7.2.1 specifies the hazard addressed, the control mechanism, and the verification method. Controls implemented in software per Clause 7.2.2 are traced through the requirements-design-test chain to ensure complete implementation and verification in the Fleet GPS Tracking Firmware.


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

[User]
Write a TRACE section on purpose and scope of the traceability matrix for GaitSense Walking Analysis, a Class B Gait Analysis Insole Firmware. Reference IEC 62304 Clause 5.7.1.
Instrumented insole firmware analyzing gait patterns and detecting asymmetries. Reports generated for orthopedic assessment.

[Assistant] Content: The purpose of this traceability matrix is to confirm complete coverage of the GaitSense Walking Analysis software requirements through design and verification per Clause 5.7.1. Bidirectional tracing enables identification of gaps (unimplemented requirements) and orphans (implementations without requirements) in the Gait Analysis Insole Firmware.


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

[User]
Write a SRS section on latency and throughput requirements for PulmoCheck Spirometry Analyzer, a Class B Spirometry Analysis Software. Reference IEC 62304 Clause 5.2.2.
Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

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


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

[User] Is ISO 14971-2 the correct reference for medical device compliance?

[Assistant] No. ISO 14971 has no Part 2. ISO/TR 24971:2020 provides guidance but is a separate technical report, not a part of ISO 14971.


[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 VisitorPass Access Management, a Class A Visitor Management System. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Kiosk application for visitor registration and badge printing in hospital lobbies. Administrative access control.

[Assistant] Content: Verification of risk control measures for the VisitorPass Access Management follows Clause 7.3.1. Each software-implemented control is tested to demonstrate that the hazardous condition is mitigated to an acceptable level. Verification results per Clause 7.3.3 are documented in the risk management file for the Visitor Management System.


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

[User]
Review this documentation excerpt for the CaloriePal (nutrition tracking app, Class A):

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

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


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

[User]
Write a FMEA section on documenting failure modes and their effects for TriagePro Emergency Scoring App, a Class B Emergency Department Triage SaMD. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Standalone tablet app implementing Manchester Triage System scoring. Guides clinicians through triage flowchart and records patient acuity level.

[Assistant] Content: Failure mode documentation for the TriagePro Emergency Scoring App per Clause 7.1.4 captures the complete chain from cause to effect for each identified failure. The FMEA worksheet records the affected function, failure mode, potential causes, effects on the Emergency Department Triage SaMD user, and current detection mechanisms.


[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 tool qualification for Class B and C for BeamPlan Radiation Treatment Planner, a Class C Radiation Treatment Planning Software. Reference IEC 62304 Clause 5.1.4.
Desktop software calculating radiation treatment plans including beam angles, dose distribution, and organ-at-risk constraints.

[Assistant] Content: Verification tools for the BeamPlan Radiation Treatment Planner Radiation Treatment Planning Software are qualified per Clause 5.1.4. Qualification records document the tool name, version, intended use in the verification process, and evidence that the tool produces correct results. Tools whose output is not relied upon for verification decisions do not require qualification.


[System] You are 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 WoundTrack Healing Analyzer, a Class B Wound Assessment App. Reference IEC 62304 Clauses 7.1, 7.1.1.
Mobile app photographing wounds and measuring area/perimeter over time to track healing progress for clinician review.

[Assistant] Content: Integration of risk management into the WoundTrack Healing Analyzer lifecycle ensures that newly identified hazards during development trigger requirement updates, design changes, and additional verification. The risk management file is a living document updated at each phase gate, with traceability maintained per Clause 7.3.2.


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

[User]
Expand requirement SRS-SEC-001: "user identity verification" (Category: security)
Project: MedImage PACS Viewer | Web PACS Image Viewer | Class A
Web-based display and annotation of DICOM medical images for radiologist review. Web-based PACS viewer enabling radiologists to review DICOM images with standard tools (windowing, measurement, MPR). View-only, no AI or diagnostic processing.

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: Access to configuration and administrative functions of the Web PACS Image Viewer shall be restricted to authenticated and authorized users.
Rationale: Unauthorized configuration changes to the Web PACS Image Viewer could compromise its intended function or patient safety.
Priority: Mandatory
Acceptance Criterion: Configuration modification is rejected when attempted without valid credentials, verified across all configurable parameters.
Source: Risk control


[System] You are 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 PathSlide Digital Pathology Viewer, a Class A Digital Pathology Viewer. Reference IEC 62304 Clause 5.2.2.
Web viewer for whole-slide digital pathology images. Pan, zoom, and annotation display. No AI-assisted diagnosis.

[Assistant] Content: This section describes the operational context of the PathSlide Digital Pathology Viewer Digital Pathology Viewer. The system is intended for Display of digitized pathology slides for reference viewing, operating on Web SPA with WebGL. Key interfaces include REST API, WebSocket tile streaming. These contextual factors drive the functional and non-functional requirements specified in subsequent sections.


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

[User]
Expand requirement SRS-FUNC-003: "audit trail and data export" (Category: functional)
Project: HumidityMap Room Condition Logger | Environmental Condition Logger | Class A
Monitoring and logging temperature/humidity in hospital storage areas. Network of IoT sensors logging temperature and humidity across hospital storage areas. Dashboard display for facility management.

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 LoRaWAN for clinical review and regulatory audit.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Environmental Condition Logger.
Priority: Desirable
Acceptance Criterion: Logged data is retrievable after power cycle, with all timestamps accurate to within 1 second of the reference clock.
Source: User need


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

[User]
Expand requirement SRS-FUNC-004: "output refresh interval for PostureGuard Desk Monitor" (Category: functional)
Project: PostureGuard Desk Monitor | Posture Wellness Display Software | Class A
Visual feedback on desk posture for personal wellness awareness. USB webcam software that estimates sitting posture and displays a wellness score. No ergonomic prescriptions or clinical assessments.

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 USB 2.0 shall refresh at the configured interval, reflecting the most recent processed data from the Posture Wellness Display Software pipeline.
Rationale: Display freshness is critical for the Posture Wellness Display Software to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: End-to-end latency from data acquisition to display update does not exceed the specified limit for 99.9% of samples.
Source: User need


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

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

"MISRA C compliance and unit testing with MC/DC coverage are mandatory for the NurseCall Hub."

[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 purpose and scope of the traceability matrix for BillingBridge Claims Processor, a Class A Claims Processing Service. Reference IEC 62304 Clause 5.7.1.
Backend service processing insurance claims from the hospital billing system. Financial processing only, no clinical data.

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


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

[User]
Write a SRS section on sensor and communication protocol requirements for RemotICU Continuous Monitoring Hub, a Class B Edge-to-Cloud ICU Monitoring Gateway. Reference IEC 62304 Clause 5.2.2.
Edge gateway collecting data from bedside monitors (SpO2, HR, BP, ventilator) and streaming to cloud for trending, alerting, and tele-ICU review.

[Assistant] Content: The RemotICU Continuous Monitoring Hub interfaces with SpO2 module via HL7v2 ADT/ORU. Interface requirements specify the physical layer, data format, sampling rate, and error handling for each connection. All interface requirements are verifiable through integration or system 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 GlucoTrack CGM (continuous glucose monitor display, Class B):

"SOUP management follows applicable guidance and industry conventions. Third-party components are evaluated per best practices for the continuous glucose monitor display."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "best practices", "applicable guidance", "industry conventions" provide no project-specific information about the GlucoTrack CGM continuous glucose monitor display. 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 Class B classification justification and implications for WeightAlert Neonatal Scale, a Class B Neonatal Scale Firmware. Reference IEC 62304 Clause 4.3.
Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

[Assistant] Content: Under IEC 62304 Clause 4.3, the WeightAlert Neonatal Scale is classified as Safety Class B. The Neonatal Scale Firmware can contribute to a hazardous situation through Precision weight measurement for neonatal patients with change-rate alerting, but the identified hazards are mitigated by clinical workflow safeguards that prevent progression to serious injury or death. This classification drives the requirement for architectural design documentation and integration testing.


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

[User]
Write a TRACE section on risk control coverage verification for RespiRate Respiratory Monitor, a Class B Respiratory Rate Monitor Firmware. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Wearable firmware monitoring respiratory rate via chest impedance. Displays rate and alerts on bradypnea/tachypnea.

[Assistant] Content: Coverage analysis for risk controls in the RespiRate Respiratory Monitor per Clause 7.3.2 ensures no software-implemented control lacks verification evidence. The analysis cross-references the risk management file with the traceability matrix and the test results to confirm complete coverage for the Respiratory Rate Monitor 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 PillRemind (medication reminder app, Class A):

"Software requirements for the PillRemind 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 SRS section on sensor and communication protocol requirements for TempWatch Body Temperature Logger, a Class A Temperature Logging Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware for a wearable temperature patch that logs skin temperature over 24 hours and displays trends. No fever detection or alerts.

[Assistant] Content: Interface requirements for the TempWatch Body Temperature Logger specify the communication protocols, data formats, and timing constraints for each external interface of the Temperature Logging Firmware. The primary data acquisition interface uses I2C with specified data rates and error detection mechanisms.


[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):

"REQ-SRS-012: The BloodBank Manager shall log all user actions with timestamps in an audit trail stored in non-volatile memory. The audit trail shall retain at least 10,000 entries. Acceptance criterion: verify log persistence across power cycles and entry count capacity. 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 LabView Portal (read-only lab results viewer, Class A):

"Independent verification of all LabView Portal development artifacts is required per Class C rigor."

[Assistant]
Verdict: FAIL
Note: Content mandates independent review for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Independent review is required only for Class C (Clause 5.5.4, 5.7.4).


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

[User]
Review this documentation excerpt for the CaloriePal (nutrition tracking app, Class A):

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

[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 EchoAssist (echocardiogram analysis aid, Class B):

"Software development follows IEC 62304 Clause 5.8.9 requirements for user acceptance testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.8.9 which does not exist. Clause 5.8 has 5.8.1 through 5.8.8 only. The reference must be corrected to a valid clause number.


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

[User]
Write a SDP section on problem reporting and investigation for AutoclaveLog Cycle Recorder, a Class A Sterilization Cycle Data Logger. Reference IEC 62304 Clauses 9.1, 9.2.
PC software recording autoclave cycle data (time, temperature, pressure) and generating compliance reports.

[Assistant] Content: Problems identified in the AutoclaveLog Cycle Recorder are reported per Clause 9.1 with anomaly description, affected component, severity, and reproduction steps. Investigation per Clause 9.2 determines root cause and impact. Relevant parties are advised per Clause 9.3 when the problem affects the Sterilization Cycle Data Logger safety or regulatory compliance.


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

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

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

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


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

[User]
Review this documentation excerpt for the AutoDose TPN (total parenteral nutrition calculator, Class C):

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

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


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

[User]
Write a TRACE section on purpose and scope of the traceability matrix for VibeCheck Vibration Analyzer, a Class A Vibration Analysis Instrument Firmware. Reference IEC 62304 Clause 5.7.1.
Portable vibration analysis firmware for predictive maintenance of industrial rotating machinery. FFT analysis of accelerometer data.

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


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

[User]
Write a SAD section on architectural overview for Class C with segregation for PaceSet Pacemaker Programmer, a Class C Cardiac Pacemaker Programmer Software. Reference IEC 62304 Clauses 5.3.1, 5.3.2, 5.3.5.
Desktop software for interrogating and programming cardiac pacemakers via telemetry wand. Incorrect programming could cause pacing failure.

[Assistant] Content: The PaceSet Pacemaker Programmer Cardiac Pacemaker Programmer Software architecture implements segregation per Clause 5.3.5 to isolate safety-critical software items from non-safety items. The safety-critical path -- from RF telemetry wand acquisition through processing to safety output -- is architecturally independent from auxiliary functions. This segregation supports the Class C verification strategy including independent review.


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

[User]
Write a SDP section on development tools and tool qualification for Class A for AquaGuard Water Quality Monitor, a Class A Water Quality Monitoring Firmware. Reference IEC 62304 Clause 5.1.4.
Firmware for a multi-parameter water quality probe measuring pH, dissolved oxygen, conductivity, and turbidity in rivers and lakes.

[Assistant] Content: For the Class A AquaGuard Water Quality Monitor, the development environment comprises C (embedded) with standard build tooling on MSP430FR (ultra-low-power). All source artifacts are version-controlled. Formal tool validation is not required at this classification level; tool versions are recorded in the configuration baseline for reproducibility.


[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 ECGInsight Rhythm Interpreter, a Class B ECG Interpretation Service. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Cloud service analyzing 12-lead ECG recordings and generating preliminary rhythm interpretations for physician review.

[Assistant] Content: Risk control verification for the ECGInsight Rhythm Interpreter 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 ECG Interpretation Service risk management file.


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

[User]
Write a TRACE section on traceability scope including risk controls for ScheduleSync Appointment Manager, a Class A Appointment Scheduling System. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Web application for scheduling patient appointments across multiple clinics. Administrative scheduling only, no clinical workflow.

[Assistant] Content: Traceability for the ScheduleSync Appointment Manager Appointment Scheduling System covers all software requirements per Clause 5.7.1 and all software-implemented risk controls per Clause 7.3.2. The combined matrix provides a single view of verification completeness for functional and safety aspects.


[System] You are a regulatory 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):

"Each CaloriePal unit undergoes boundary value analysis, equivalence class partitioning, and error guessing as part of unit verification per Clause 5.5."

[Assistant]
Verdict: FAIL
Note: Content mandates unit verification techniques per Clause 5.5 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 SDP section on risk control verification and traceability for PedDose Pediatric Dosing App, a Class B Pediatric Dosing Calculator App. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Mobile reference app for pediatric drug dosing with weight-based calculations and age-specific ranges.

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


[System] You are a regulatory 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 PostureGuard Desk Monitor, a Class A Posture Wellness Display Software. Reference IEC 62304 Clause 5.1.8.
USB webcam software that estimates sitting posture and displays a wellness score. No ergonomic prescriptions or clinical assessments.

[Assistant] Content: The PostureGuard Desk Monitor documentation set is limited to the deliverables required for Class A: the SDP, SRS, system test records, software release record, and the risk management file. No architecture document, detailed design specification, unit test report, or integration test report is produced for this Posture Wellness Display Software.


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

[User] Does IEC 62304:2020 exist?

[Assistant] No. There is no 2020 edition of IEC 62304. The current edition is IEC 62304:2006+AMD1:2015.


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

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

"Risk control measures are implemented per ISO 14971-1 Clause 7."

[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 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

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

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

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


[System] You are an IEC 62304 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 LabStream LIS Middleware, a Class A Laboratory Information Middleware. Reference IEC 62304 Clause 5.7.4.
Middleware software connecting laboratory analyzers to the hospital LIS. Routes results, applies auto-validation rules, and flags critical values.

[Assistant] Content: Gap analysis for the LabStream LIS Middleware per Clause 5.7.4 examines the traceability matrix for completeness. Requirements without verification are flagged as critical gaps. Design elements without requirements are evaluated for removal or requirement creation. The Laboratory Information Middleware cannot be released until all gaps are resolved.


[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):

"Per IEC 62304 Clause 5.2, requirements are defined. Per IEC 62304 Clause 5.2, requirements are documented. Per IEC 62304 Clause 5.2, requirements are analyzed. Per IEC 62304 Clause 5.2, requirements are verified."

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