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

[User]
Write a TRACE section on gap identification and coverage analysis for ThermoWatch Core Temperature Monitor, a Class B Core Temperature Monitor Firmware. Reference IEC 62304 Clause 5.7.4.
Continuous core temperature monitoring firmware using an ingestible sensor pill. Displays temperature trend with configurable alerts.

[Assistant] Content: The ThermoWatch Core Temperature Monitor traceability gap analysis identifies three types of gaps: unverified requirements, orphaned implementations, and unlinked test cases. Each gap is documented with a resolution plan and tracked to closure. Clause 5.7.4 verification of the Core Temperature Monitor Firmware system test is not complete until all gaps are resolved.


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

[User]
Expand requirement SRS-INTF-002: "clinical system integration interface" (Category: interface)
Project: MindCalm Meditation Timer | Meditation Wellness App | Class A
Guided meditation timing with optional passive biometric display. Mobile app providing guided meditation timers with optional heart rate display during sessions. Heart rate shown for interest only, not diagnostic.

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

[Assistant]
Description: The MindCalm Meditation Timer shall exchange data with external systems via HealthKit/Google Fit API using the specified message format with error handling.
Rationale: Interoperability enables integration of Meditation Wellness App 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 requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-SAFE-001: "safe state transition on critical failure" (Category: safety)
Project: PulmoCheck Spirometry Analyzer | Spirometry Analysis Software | Class B
Analysis and interpretation of spirometry test data with predicted value comparison. Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

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: A deterministic safe-state transition shall be triggered by any detected critical fault condition in the PulmoCheck Spirometry Analyzer, with all active outputs brought to a known safe configuration.
Rationale: Fail-safe behavior is essential to prevent the Spirometry Analysis Software from causing harm when its software detects an unrecoverable error.
Priority: Mandatory
Acceptance Criterion: All 20 defined fault scenarios result in correct safe-state entry within timing limits across 10 iterations each.
Source: Risk control


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

[User]
Expand requirement SRS-SEC-001: "access control and authorization" (Category: security)
Project: MindCalm Meditation Timer | Meditation Wellness App | Class A
Guided meditation timing with optional passive biometric display. Mobile app providing guided meditation timers with optional heart rate display during sessions. Heart rate shown for interest only, not diagnostic.

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

[Assistant]
Description: User authentication shall be enforced for all configuration changes to the MindCalm Meditation Timer, with credential validation before granting access.
Rationale: Unauthorized configuration changes to the Meditation Wellness App 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 SDP section on development platform and build infrastructure for PhysioTrack Rehabilitation Monitor, a Class B Physical Therapy Tracking System. Reference IEC 62304 Clause 5.1.4.
Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

[Assistant] Content: Source code for the PhysioTrack Rehabilitation Monitor Physical Therapy Tracking System is written in C (embedded) + TypeScript (cloud) and compiled for nRF52840 + web dashboard. The build pipeline is automated and deterministic -- identical source revisions produce identical binaries. All build tool versions are captured in the configuration baseline per Clause 5.1.4.


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

[User]
Write a THREAT section on system description for threat modeling for CardioRhythm ECG Analyzer, a Class B Single-Lead ECG Device Firmware. Reference IEC 62304 Clause 5.2.1.
Portable ECG device firmware acquiring single-lead ECG and classifying basic rhythm types. Incorrect classification could delay diagnosis.

[Assistant] Content: The CardioRhythm ECG Analyzer threat model scope encompasses the Single-Lead ECG Device Firmware, its communication interfaces (SPI, BLE 5.0, USB), stored data, and the operational environment. Data flows between the ADS1292R ECG AFE and the application logic, and between the application and USB are analyzed for potential security threats.


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

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

"The DialysisGuard addresses IEC 62304 Clause 10.1 (post-market surveillance) through formal review."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 10.1 which does not exist. IEC 62304 has no Clause 10. Standard ends at Clause 9. 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 verification strategy for Class B -- integration and system testing for SurgiPlan 3D Surgical Planner, a Class B 3D Surgical Planning SaMD. Reference IEC 62304 Clauses 5.6, 5.6.3, 5.7.
Desktop SaMD for orthopedic surgeons to plan joint replacement procedures on 3D CT reconstructions. Outputs implant sizing and positioning specifications.

[Assistant] Content: Integration and system testing constitute the mandatory verification activities for the SurgiPlan 3D Surgical Planner 3D Surgical Planning SaMD at Class B. Integration tests per Clause 5.6 verify data exchange across architectural boundaries, while system tests per Clause 5.7 exercise the complete software against the SRS. Unit testing may be applied to selected modules but is not required.


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

[User]
Write a FMEA section on risk control verification for ConsentView Informed Consent Archive, a Class A Consent Document Viewer. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Web portal for patients and staff to view signed informed consent documents. Read-only document viewer.

[Assistant] Content: Verification of risk control measures for the ConsentView Informed Consent Archive 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 Consent Document Viewer.


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

[User]
Expand requirement SRS-SEC-001: "patient data protection" (Category: security)
Project: BSACalc Body Surface Area Tool | BSA Calculator Web App | Class B
Calculating body surface area for oncology dose determination. Web calculator for body surface area using Mosteller and DuBois formulas. Used for chemotherapy dose calculations.

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: Patient-identifiable data stored by the BSACalc Body Surface Area Tool shall be encrypted at rest using a validated cryptographic algorithm with a key length of at least 256 bits.
Rationale: Data-at-rest encryption is required to meet privacy regulations and protect patient confidentiality.
Priority: Mandatory
Acceptance Criterion: Cryptographic implementation validated against NIST standards with no known vulnerabilities in the selected algorithm.
Source: Regulatory


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

[User]
Write a SRS section on latency and throughput 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: Performance requirements for the PathSlide Digital Pathology Viewer specify maximum latencies, throughput rates, and resource consumption limits for the Digital Pathology Viewer operating on Web SPA with WebGL. Latency requirements define the maximum time from input event to output response for each critical processing path during Display of digitized pathology slides for reference viewing.


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

[User]
Expand requirement SRS-PERF-001: "end-to-end processing latency" (Category: performance)
Project: BeamPlan Radiation Treatment Planner | Radiation Treatment Planning Software | Class C
Calculating optimal radiation beam configurations and dose distributions for cancer treatment. Desktop software calculating radiation treatment plans including beam angles, dose distribution, and organ-at-risk constraints.

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 Radiation Treatment Planning Software 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 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 WoundTrack Healing Analyzer, a Class B Wound Assessment App. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Mobile app photographing wounds and measuring area/perimeter over time to track healing progress for clinician review.

[Assistant] Content: Each risk control for the WoundTrack Healing Analyzer 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 Wound Assessment App.


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

[User]
Write a SRS section on requirements conventions and identification scheme for TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

[Assistant] Content: The TriageAI Emergency Triage Assistant SRS follows a structured format: each requirement has a unique ID, a type classification, a priority, a rationale, and acceptance criteria per Clause 5.2.2. Requirements implementing risk control measures per Clause 5.2.3 are explicitly marked to ensure they receive verification attention proportional to their safety significance.


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

[User]
Write a SAD section on SOUP component integration and requirements for HemaCount Digital Cell Counter, a Class B IVD Digital Cell Counter Software. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Desktop software performing automated differential white blood cell counting on digitized blood smear images using computer vision.

[Assistant] Content: SOUP integration in the HemaCount Digital Cell Counter architecture follows Clause 5.3.3 and Clause 5.3.4. Each SOUP item has documented functional requirements, performance requirements, and platform dependencies. The IVD Digital Cell Counter Software architecture ensures SOUP components are isolated behind defined interfaces to limit the impact of SOUP defects.


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

[User]
Write a TRACE section on risk control coverage verification for PathSlide Digital Pathology Viewer, a Class A Digital Pathology Viewer. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Web viewer for whole-slide digital pathology images. Pan, zoom, and annotation display. No AI-assisted diagnosis.

[Assistant] Content: Coverage analysis for risk controls in the PathSlide Digital Pathology Viewer 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 Digital Pathology Viewer.


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

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

"Standards compliance for the HeartLink cardiac telemetry system is established through IEC 62304:2006+AMD1:2015 (Clauses 5, 7, 8, 9), ISO 14971:2019 (all clauses), and ISO 13485:2016 (Clause 7.3 design controls). All citations reference the current editions."

[Assistant]
Verdict: PASS
Note: Content uses the correct IEC 62304 citation; correctly references ISO 14971:2019; correctly references ISO 13485:2016. Standards references are accurate.


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

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

"Risk control measures are implemented per IEC 62304-5 Clause 7."

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


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

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

"Cybersecurity considerations are addressed as applicable to the patient call system dashboard. Controls are implemented following industry best practices and guidance."

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


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

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

"Referenced standards for the PhysioTrack Rehab include IEC 62304:2006+AMD1:2015 (software lifecycle), ISO 14971:2019 (risk management), and ISO 13485:2016 (QMS). IEC 81001-5-1:2021 is referenced for cybersecurity considerations."

[Assistant]
Verdict: PASS
Note: Content uses the correct IEC 62304 citation; correctly references ISO 14971:2019; correctly references ISO 13485:2016. Standards references are accurate.


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

[User] Enumerate the requirements in IEC 62304 Clause 8.1.

[Assistant]
IEC 62304 Clause 8.1 (Configuration identification) contains the following sub-clauses:

- Clause 8.1: Configuration identification
- Clause 8.1.1: Establish means to identify configuration items
- Clause 8.1.2: Identify SOUP
- Clause 8.1.3: Identify system configuration documentation

These are the only valid sub-clauses under 8.1. No additional sub-clauses exist.


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

[User]
Expand requirement SRS-DATA-001: "stored data corruption detection" (Category: data)
Project: RemotICU Continuous Monitoring Hub | Edge-to-Cloud ICU Monitoring Gateway | Class B
Aggregating bedside monitor data at the edge and streaming to cloud for tele-ICU clinical oversight. Edge gateway collecting data from bedside monitors (SpO2, HR, BP, ventilator) and streaming to cloud for trending, alerting, and tele-ICU 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: Data integrity of all stored records in the Edge-to-Cloud ICU Monitoring Gateway shall be verified using CRC or equivalent checksums upon read-back.
Rationale: Corrupted data must be identified to prevent clinical decisions based on unreliable measurements.
Priority: Mandatory
Acceptance Criterion: Intentionally corrupted records are detected and flagged with 100% detection rate across 100 injected corruption events.
Source: System requirement


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

[User]
Write a FMEA section on risk control measures and implementation for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: The CochleaMap CI Fitting Software 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 Cochlear Implant Fitting Software.


[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 DermaScan AI (skin lesion classifier, Class B):

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

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the DermaScan AI (skin lesion classifier, 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 SRS section on safety requirements for Class B for TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clauses 5.2.2, 5.2.3.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

[Assistant] Content: Risk control measures for the TriageAI Emergency Triage Assistant are expressed as verifiable safety requirements per Clause 5.2.3. The ED Triage Decision Support App implements defensive data processing, boundary condition detection, and communication timeout handling. Each safety requirement is verified through integration testing (Clause 5.6) or system testing (Clause 5.7).


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

[User]
Expand requirement SRS-FUNC-001: "configurable alarm limits for monitored parameters" (Category: functional)
Project: FallRisk Inpatient Assessment Tool | Fall Risk Assessment App | Class B
Calculating fall risk scores for hospitalized patients to guide nursing interventions. Web app calculating fall risk scores for inpatients based on mobility, medication, and cognitive 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: The Fall Risk Assessment App shall monitor all active parameters against user-configured thresholds and activate appropriate alarm signals when limits are breached.
Rationale: Alarm functionality is a safety-critical feature of the Fall Risk Assessment App that directly supports clinical decision-making.
Priority: Mandatory
Acceptance Criterion: Alarm triggers within the specified response time of a threshold crossing, measured over 50 test crossings with no false negatives.
Source: Risk control


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

[User]
Expand requirement SRS-PERF-001: "end-to-end processing latency" (Category: performance)
Project: PulseRing Smart Ring Monitor | Wearable Smart Ring Firmware + Companion App | Class B
Continuous photoplethysmography-based heart rate and SpO2 monitoring via wearable ring with mobile companion. Wearable smart ring firmware measuring continuous PPG for heart rate and SpO2 with BLE streaming to companion mobile app for trend display.

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

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


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

[User]
Write a SDP section on configuration identification approach for RadOnco Cloud Treatment Planner, a Class C Cloud Radiation Treatment Planning SaMD. Reference IEC 62304 Clauses 8.1, 8.1.1.
Cloud-based radiation oncology treatment planning system using GPU clusters for Monte Carlo dose calculation. Treatment plans directly drive linear accelerator delivery.

[Assistant] Content: Configuration items for the RadOnco Cloud Treatment Planner include source code, build scripts, the SDP itself, software requirements, and verification records. Each item is uniquely identified by its path in the version control repository and its revision identifier, ensuring that any configuration baseline can be precisely reproduced as required by IEC 62304 Clause 8.1.


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

[User]
Write a SRS section on data retention and integrity requirements 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: The PressoTrack Blood Pressure Trending data requirements define how the Ambulatory Blood Pressure Monitor Firmware stores, retrieves, and protects data acquired during Automated periodic blood pressure measurement and trending over 24 hours. Requirements specify data format, retention duration, backup frequency, and the behavior when data corruption is detected.


[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):

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

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


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

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

"The RetinaScan Pro addresses IEC 62304 Clause 5.3.7 for automated regression testing and Clause Annex A.1 for performance benchmarking."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.3.7 and Annex A.1, neither of which exists. Clause 5.3 has 5.3.1 through 5.3.6 only. IEC 62304 annexes are informative, not cited as requirements. All clause references must be corrected.


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

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

"Maintenance activities follow ISO 13485-2 Clause 6."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 13485-2" which is incorrect. ISO 13485 has no Part 2. All references must be corrected.


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

[User]
Expand requirement SRS-PERF-001: "computational accuracy requirement" (Category: performance)
Project: CardioLoop Cardiac Resync Controller | CRT Optimization Firmware | Class C
Real-time optimization of biventricular pacing parameters based on hemodynamic sensor feedback. Firmware for cardiac resynchronization therapy devices optimizing biventricular pacing based on hemodynamic feedback.

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: Computational results produced by the CardioLoop Cardiac Resync Controller shall be accurate to within the specified tolerance, validated against reference calculations.
Rationale: Measurement accuracy directly affects clinical decisions based on the CRT Optimization Firmware 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 SDP section on risk control requirements traceability for AnesBot Automated Anesthesia Controller, a Class C Automated Anesthesia Delivery Software. Reference IEC 62304 Clause 5.2.3.
Software controlling target-controlled infusion of propofol based on BIS monitoring. Overdose could cause respiratory arrest.

[Assistant] Content: Clause 5.2.3 requires that risk control measures implemented in the AnesBot Automated Anesthesia Controller software appear as traceable requirements. The traceability chain runs from the ISO 14971 hazard analysis to the SRS requirement to the test case verifying the control's effectiveness in the Automated Anesthesia Delivery Software.


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

[User]
Expand requirement SRS-DATA-002: "record keeping duration" (Category: data)
Project: SeismicWatch Earthquake Early Warning | Seismic Early Warning Firmware | Class A
Detecting seismic P-waves and providing early warning of potentially damaging earthquakes. Firmware for a network of MEMS accelerometers providing earthquake early warning by detecting P-waves and estimating magnitude.

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

[Assistant]
Description: Measurement records stored by the Seismic Early Warning Firmware shall be maintained for the configured retention period before eligible for overwrite.
Rationale: Data retention supports clinical trend analysis and regulatory requirements for record keeping associated with the Seismic Early Warning Firmware.
Priority: Mandatory
Acceptance Criterion: Retention period validation: records created at time T are still accessible at T + retention period.
Source: Regulatory


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

[User]
Expand requirement SRS-PERF-002: "real-time performance requirement" (Category: performance)
Project: ScheduleSync Appointment Manager | Appointment Scheduling System | Class A
Administrative scheduling and calendar management for clinical appointments. Web application for scheduling patient appointments across multiple clinics. Administrative scheduling only, no clinical workflow.

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: Bounded processing latency ensures the Appointment Scheduling System provides readings reflecting the current state without clinically significant delay.
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 an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-INTF-002: "sensor data link requirements" (Category: interface)
Project: InsuPrecise Insulin Pump Controller | Insulin Pump Controller Firmware | Class C
Automated insulin delivery control with programmable basal rates and bolus calculations. Embedded firmware controlling insulin delivery in a patch-type insulin pump. Incorrect dosing could cause severe hypoglycemia or diabetic ketoacidosis.

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 Insulin Pump Controller Firmware sensor interface shall establish and maintain reliable communication with the micro-flow sensor via BLE 5.0 to companion app.
Rationale: Reliable sensor communication is the foundation of the Insulin Pump Controller Firmware data acquisition pipeline.
Priority: Mandatory
Acceptance Criterion: Communication operates without data loss for 72 hours continuously, with automatic recovery from simulated failures within the specified time.
Source: System requirement


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

[User]
Write a SAD section on interface design between software items for PulseRing Smart Ring Monitor, a Class B Wearable Smart Ring Firmware + Companion App. Reference IEC 62304 Clause 5.3.2.
Wearable smart ring firmware measuring continuous PPG for heart rate and SpO2 with BLE streaming to companion mobile app for trend display.

[Assistant] Content: Internal interface design for the PulseRing Smart Ring Monitor follows Clause 5.3.2. Each interface is documented with its function signature, parameter constraints, return value semantics, and thread safety guarantees. The Wearable Smart Ring Firmware + Companion App interfaces are designed for testability, supporting both integration testing and fault injection.


[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 risk evaluation and anomaly management for PressoTrack Blood Pressure Trending, a Class B Ambulatory Blood Pressure Monitor Firmware. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Firmware for an automated blood pressure cuff that trends readings over 24 hours. Trending errors could mask hypertensive episodes.

[Assistant] Content: Known anomalies in SOUP components used by the PressoTrack Blood Pressure Trending are evaluated per Clause 7.1.3 against the specific usage context of the Ambulatory Blood Pressure Monitor Firmware. Each known anomaly is assessed for its potential to contribute to a hazardous situation, and risk control measures are implemented where the anomaly is relevant to Automated periodic blood pressure measurement and trending over 24 hours.


[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):

"Unit testing for the PillRemind shall use mutation testing to ensure test suite effectiveness, targeting a mutation score of at least 85%."

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


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

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

"Software problem resolution follows ISO 13485-1 Clause 9."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 13485-1" which is incorrect. ISO 13485 is a single-part standard. The correct citation is ISO 13485:2016. All references must be corrected.


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

[User]
Write a FMEA section on FMEA scope for Class A -- simplified analysis for MindCalm Meditation Timer, a Class A Meditation Wellness App. Reference IEC 62304 Clause 7.1.1.
Mobile app providing guided meditation timers with optional heart rate display during sessions. Heart rate shown for interest only, not diagnostic.

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


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

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

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

[Assistant]
Description: Measurement records stored by the Sleep Apnea Screening App shall be maintained for the configured retention period before eligible for overwrite.
Rationale: Data retention supports clinical trend analysis and regulatory requirements for record keeping associated with the Sleep Apnea Screening App.
Priority: Mandatory
Acceptance Criterion: Retention period validation: records created at time T are still accessible at T + retention period.
Source: Regulatory


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

[User]
Write a SRS section on data retention and integrity requirements for AuditTrail QMS Event Logger, a Class A QMS Audit Trail Service. Reference IEC 62304 Clause 5.2.2.
Microservice capturing and storing quality management system audit events. Logging and reporting only.

[Assistant] Content: Persistent data managed by the AuditTrail QMS Event Logger includes configuration parameters, acquired measurements from data sources, and operational logs. Data integrity requirements specify error detection mechanisms and the QMS Audit Trail Service response to data corruption events.


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

[User]
Write a TRACE section on purpose and scope of the traceability matrix for CardioRhythm ECG Analyzer, a Class B Single-Lead ECG Device Firmware. Reference IEC 62304 Clause 5.7.1.
Portable ECG device firmware acquiring single-lead ECG and classifying basic rhythm types. Incorrect classification could delay diagnosis.

[Assistant] Content: The purpose of this traceability matrix is to confirm complete coverage of the CardioRhythm ECG Analyzer 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 Single-Lead ECG Device Firmware.


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

[User]
Expand requirement SRS-FUNC-002: "real-time data presentation on RS-232 serial" (Category: functional)
Project: AutoclaveLog Cycle Recorder | Sterilization Cycle Data Logger | Class A
Recording and reporting autoclave sterilization cycle parameters. PC software recording autoclave cycle data (time, temperature, pressure) and generating compliance reports.

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 RS-232 serial shall refresh at the configured interval, reflecting the most recent processed data from the Sterilization Cycle Data Logger pipeline.
Rationale: Timely display updates ensure the user observes current readings without perceiving lag.
Priority: Mandatory
Acceptance Criterion: Measured display update interval is within 10% of the specified refresh period across 100 consecutive update cycles.
Source: User need


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

[User]
Write a SDP section on verification strategy for Class B -- integration and system testing for NutriCalc TPN Formulation Tool, a Class B TPN Formulation Calculator. Reference IEC 62304 Clauses 5.6, 5.6.3, 5.7.
Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

[Assistant] Content: Verification of the NutriCalc TPN Formulation Tool at Class B encompasses integration testing and system testing. Integration tests per Clause 5.6.3 exercise the interfaces between software items defined in the architecture, confirming data integrity across module boundaries. System tests per Clause 5.7.1 validate the TPN Formulation Calculator against all requirements in the SRS on Windows desktop.


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

[User]
Write a FMEA section on FMEA scope for Class C -- comprehensive analysis for AutoPancreas Closed-Loop Glucose Controller, a Class C Artificial Pancreas Controller Firmware. Reference IEC 62304 Clause 7.1.1.
Artificial pancreas firmware integrating CGM readings with insulin pump delivery using a PID control algorithm. Life-sustaining closed-loop system.

[Assistant] Content: The AutoPancreas Closed-Loop Glucose Controller FMEA per Clause 7.1.1 provides exhaustive coverage of every software function in the Artificial Pancreas Controller Firmware that could contribute to a hazardous situation. Each function is analyzed for failure modes including incorrect output, missing output, untimely output, and unexpected output. Risk priority numbers drive verification and risk control priorities.


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

[User]
Expand requirement SRS-FUNC-005: "user-configurable operating parameters" (Category: functional)
Project: PathCloud AI Histology Analyzer | Cloud SaMD Histopathology Analysis Platform | Class B
AI-assisted identification of suspicious regions in digitized histology slides for pathologist review. Cloud-hosted SaMD analyzing whole-slide histology images with deep learning to flag suspicious regions for pathologist review. Runs as a multi-tenant SaaS.

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

[Assistant]
Description: Configuration changes to the PathCloud AI Histology Analyzer shall be validated against allowed ranges before acceptance and persisted to survive power loss.
Rationale: Configurable parameters allow the Cloud SaMD Histopathology Analysis Platform to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: Configuration round-trip test: set, power-cycle, read-back for all parameters with 100% accuracy.
Source: User need


[System] You are an IEC 62304 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):

"Each RadView DICOM module undergoes unit testing followed by integration testing. System testing validates end-to-end behavior. All results are independently reviewed."

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


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

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

"The SleepWell addresses IEC 62304 Clause 5.5.6 for user acceptance testing and Clause 6.4 for continuous monitoring."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.5.6 and 6.4, neither of which exists. Clause 5.5 has 5.5.1 through 5.5.5 only. Clause 6 has 6.1, 6.2, 6.3 only. All clause references must be corrected.


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

[User]
Write a SDP section on development methodology for Class B for BalanceBoard Vestibular Trainer, a Class B Balance Training Platform Firmware. Reference IEC 62304 Clause 5.1.1.
Force plate firmware measuring center-of-pressure excursions during balance exercises. Provides real-time visual biofeedback.

[Assistant] Content: The lifecycle model for the BalanceBoard Vestibular Trainer combines iterative development with V-model verification gates required by the Class B classification. Architectural design (Clause 5.3) is formally reviewed, integration testing (Clause 5.6) validates inter-module interactions, and system testing (Clause 5.7) confirms end-to-end behavior of the Balance Training Platform Firmware.


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

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

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

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


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

[User]
Write a SAD section on interface design between software items for NeuroTune DBS Programmer, a Class C Deep Brain Stimulator Programmer App. Reference IEC 62304 Clause 5.3.2.
Tablet application programming deep brain stimulation implants for movement disorders. Stimulation parameter errors could cause neurological harm.

[Assistant] Content: Internal interface design for the NeuroTune DBS Programmer follows Clause 5.3.2. Each interface is documented with its function signature, parameter constraints, return value semantics, and thread safety guarantees. The Deep Brain Stimulator Programmer App interfaces are designed for testability, supporting both integration testing and fault injection.


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

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

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

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


[System] You are a regulatory 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 platform and build infrastructure for DoseCalc Medication Calculator, a Class B Medication Dose Calculator App. Reference IEC 62304 Clause 5.1.4.
Mobile app calculating medication doses based on patient weight, age, and renal function. Incorrect calculations could cause underdosing or adverse effects.

[Assistant] Content: The DoseCalc Medication Calculator build environment uses Swift on iOS. Continuous integration builds execute on every commit, ensuring early detection of compilation errors and regression failures. Toolchain versions are locked to the configuration baseline and recorded in the Software Configuration Management Plan.


[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):

"Unit testing for the RadView DICOM shall use mutation testing to ensure test suite effectiveness, targeting a mutation score of at least 85%."

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


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

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

"Maintenance activities follow ISO 14901 Clause 6."

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


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

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

"The EchoAssist addresses IEC 62304 Clause 5.1.12 for continuous monitoring and Clause 5.10 for performance benchmarking."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.1.12 and 5.10, neither of which exists. Clause 5.1 has 5.1.1 through 5.1.11 only. Clause 5 ends at 5.8. All clause references must be corrected.


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

[User]
Write a SRS section on baseline security requirements for PharmaSafe CDSS, a Class B Clinical Decision Support System. Reference IEC 62304 Clause 5.2.2.
Clinical decision support system integrated into hospital EMR providing real-time drug-drug interaction alerts, allergy checking, and dosing guidance.

[Assistant] Content: Security requirements for the PharmaSafe CDSS address authentication, data protection, and access control for the Clinical Decision Support System. All persistent data is encrypted at rest, and data in transit over REST API uses transport layer encryption. Security requirements are aligned with IEC 81001-5-1:2021.


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

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

"Per IEC 62304 Clause 5.1.1, the RadBeam Planner development plan defines the development process. Per IEC 62304 Clause 5.1.1, this plan establishes development activities. Per IEC 62304 Clause 5.1.1, the software development is governed by this plan. Per IEC 62304 Clause 5.1.1, all development follows this plan."

[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 RadBeam Planner.


[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 PharmLog Medication History Viewer, a Class A Medication History Viewer. Reference IEC 62304 Clause 5.2.2.
Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

[Assistant] Content: External dependencies of the PharmLog Medication History Viewer include the iOS operating environment, input hardware, and FHIR MedicationDispense API. The Medication History Viewer requirements assume these dependencies operate within their specified parameters; failure modes of external components are addressed in the risk analysis.


[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: "continuous data sampling from primary sensor" (Category: functional)
Project: SupplyChain Procurement Portal | Supply Chain Procurement System | Class A
Managing procurement of medical supplies with approval tracking. Web portal for ordering medical supplies with approval workflows. Procurement and logistics only.

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

[Assistant]
Description: Data from the primary sensor shall be acquired by the SupplyChain Procurement Portal at the configured rate, with each sample timestamped and queued for processing.
Rationale: Continuous data acquisition from the primary sensor is the fundamental input for Managing procurement of medical supplies with approval tracking.
Priority: Mandatory
Acceptance Criterion: Verified by test: software acquires sensor data continuously for 60 minutes without data loss, confirmed by comparing acquisition count against expected count at the configured sampling rate.
Source: System requirement


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

[User]
Write a SDP section on safety classification process and documentation for BreathSync ICU Ventilator Controller, a Class C ICU Ventilator Controller Software. Reference IEC 62304 Clause 4.3.
Software controlling an ICU mechanical ventilator with multiple ventilation modes (volume, pressure, SIMV). Failure could result in patient death.

[Assistant] Content: Clause 4.3 of IEC 62304 requires classification of the BreathSync ICU Ventilator Controller based on the severity of harm that could result from software malfunction. The classification was performed in conjunction with the ISO 14971 risk analysis for the ICU Ventilator Controller Software and is subject to re-evaluation if the intended use or risk profile changes per Clause 5.2.4.


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

[User]
Expand requirement SRS-FUNC-002: "output refresh interval for FleetTrack GPS Tracking Module" (Category: functional)
Project: FleetTrack GPS Tracking Module | Fleet GPS Tracking Firmware | Class A
Real-time GPS tracking and geofence monitoring of fleet vehicles. Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

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

[Assistant]
Description: The FleetTrack GPS Tracking Module shall update the displayed values on the LTE-M cellular at intervals no greater than the specified refresh period.
Rationale: Display freshness is critical for the Fleet GPS Tracking Firmware to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: End-to-end latency from data acquisition to display update does not exceed the specified limit for 99.9% of samples.
Source: User need


[System] You are an IEC 62304 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 PacePilot (pacemaker programmer, Class C):

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

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


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

[User]
Expand requirement SRS-DATA-002: "record keeping duration" (Category: data)
Project: ScreenFlow Population Health Screener | Serverless Population Health Screening SaMD | Class A
Processing population health screening questionnaires and generating risk-stratified follow-up recommendations. Serverless cloud application processing population-level health screening questionnaires and flagging individuals for follow-up based on risk scoring algorithms.

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

[Assistant]
Description: Measurement records stored by the Serverless Population Health Screening SaMD shall be maintained for the configured retention period before eligible for overwrite.
Rationale: Regulatory compliance requires that measurement records be available for the specified retention period.
Priority: Mandatory
Acceptance Criterion: Oldest data record remains retrievable after continuous operation for the specified retention period.
Source: Regulatory


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

[User]
Write a SDP section on risk management integration into the lifecycle for RetinaStim Visual Prosthesis Controller, a Class C Retinal Prosthesis Controller Firmware. Reference IEC 62304 Clauses 7.1, 7.1.1.
Firmware driving a retinal implant electrode array based on camera input processing. Stimulation errors could cause retinal damage.

[Assistant] Content: Risk management for the RetinaStim Visual Prosthesis Controller follows IEC 62304 Clause 7 and ISO 14971:2019. Hazard identification per Clause 7.1.1 is performed during requirements analysis and updated as the Retinal Prosthesis Controller Firmware design evolves. Risk control measures are traced to software requirements and verified through the testing activities defined in this plan.


[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 GasMonitor Anesthetic Gas Logger, a Class A Anesthetic Gas Concentration Logger. Reference IEC 62304 Clause 5.2.2.
Software logging waste anesthetic gas concentrations in operating rooms for occupational safety compliance. Recording only.

[Assistant] Content: The GasMonitor Anesthetic Gas Logger shall meet defined latency bounds for all safety-relevant processing paths. Throughput requirements specify the data rates the Anesthetic Gas Concentration Logger must sustain from IR gas analyzer without data loss or processing backlog on ARM Cortex-M4.


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

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

"This plan is prepared in compliance with ISO 14971:2020 and ISO 13485:2016."

[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 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 FridgeGuard Temperature Logger, a Class A Cold Chain Temperature Logger. Reference IEC 62304 Clause 5.2.2.
Firmware logging refrigerator temperatures for vaccine and medication cold chain compliance. Records and displays data, no alerts that drive clinical decisions.

[Assistant] Content: The FridgeGuard Temperature Logger data pipeline requirements specify end-to-end data flow from DS18B20 temperature sensor through processing to output on 1-Wire. Requirements include input validation, range checking, unit conversion, and output formatting for Continuous logging and display of storage temperatures for compliance documentation.


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

[User]
Write a SDP section on risk management integration into the lifecycle for SupplyChain Procurement Portal, a Class A Supply Chain Procurement System. Reference IEC 62304 Clauses 7.1, 7.1.1.
Web portal for ordering medical supplies with approval workflows. Procurement and logistics only.

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


[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 data paths and processing pipeline for PainScale Digital Assessment Tool, a Class B Pain Assessment Tool. Reference IEC 62304 Clauses 5.3.1, 5.3.2.
Web app for standardized pain assessment using validated scales (VAS, NRS, McGill). Records longitudinal pain data for treatment monitoring.

[Assistant] Content: The processing pipeline of the PainScale Digital Assessment Tool consists of sequential data transformations from raw input through processed output. Interface contracts per Clause 5.3.2 define the data format, timing, and error conditions at each pipeline stage boundary. The Pain Assessment Tool architecture supports both streaming and batch processing modes where required.


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

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


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

[User] Enumerate the requirements in IEC 62304 Clause 7.2.

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

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

"The DermaScan AI software development plan addresses Clause 5.1 requirements. Planning includes risk management (Clause 5.1.7), documentation (Clause 5.1.8), and configuration management (Clause 5.1.9). The plan is kept updated per Clause 5.1.2."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the DermaScan AI (skin lesion classifier, Class B). Standards references are accurate.


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

[User]
Expand requirement SRS-DATA-001: "data integrity validation" (Category: data)
Project: HeartView Resting HR Display | Heart Rate Display Firmware | Class A
Passive display of resting heart rate for wellness monitoring. Wearable firmware that shows resting heart rate on a small OLED screen. Read-only display with no arrhythmia detection or clinical alerts.

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

[Assistant]
Description: Data integrity of all stored records in the Heart Rate Display Firmware shall be verified using CRC or equivalent checksums upon read-back.
Rationale: Data integrity mechanisms ensure measurement records retrieved from the Heart Rate Display Firmware are trustworthy for clinical review.
Priority: Mandatory
Acceptance Criterion: Integrity check correctly identifies all corrupted records with zero false positives on uncorrupted data.
Source: System requirement


[System] You are 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 SeismicWatch Earthquake Early Warning, a Class A Seismic Early Warning Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware for a network of MEMS accelerometers providing earthquake early warning by detecting P-waves and estimating magnitude.

[Assistant] Content: The SeismicWatch Earthquake Early Warning system overview identifies all external entities interacting with the Seismic Early Warning Firmware: input sources (ADXL355 3-axis MEMS accelerometer (low noise)), output destinations (alarm relay), and the Zynq-7000 SoC (FPGA + ARM) execution environment. Requirements for each external interface are documented in the interface requirements section.


[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: "RAM and storage constraints" (Category: performance)
Project: OBDView Diagnostic Display | Vehicle Diagnostic Display App | Class A
Displaying vehicle diagnostic information from OBD-II interface for driver and mechanic use. Mobile app connecting to vehicle OBD-II port to display engine parameters, fault codes, and emissions data.

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

[Assistant]
Description: Peak memory consumption of the Vehicle Diagnostic Display App shall not exceed the allocated budget, with sufficient margin for stack overflow protection.
Rationale: Memory constraints are fixed by the Android hardware and must be respected to prevent resource exhaustion during operation.
Priority: Mandatory
Acceptance Criterion: Peak RAM usage during worst-case scenario does not exceed the specified limit, with minimum margin remaining.
Source: System requirement


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

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

"Unit verification for the ChemoCalc follows Clause 5.5. Each unit has acceptance criteria per Clause 5.5.3 and additional criteria per Clause 5.5.4. Verification demonstrates MC/DC coverage for modules identified as safety-critical in the risk analysis."

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


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

[User]
Expand requirement SRS-INTF-002: "sensor data link requirements" (Category: interface)
Project: AirSentry Urban Air Quality Station | Air Quality Monitoring Station Firmware | Class A
Continuous measurement and public reporting of urban air quality parameters. IoT firmware for urban air quality monitoring stations measuring PM2.5, NO2, O3, and CO. Publishes data to public API.

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

[Assistant]
Description: Communication with the Alphasense NO2-B43F over 4G LTE shall include CRC-based error detection, automatic retry, and graceful degradation on persistent failure.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Air Quality Monitoring Station Firmware output.
Priority: Mandatory
Acceptance Criterion: Communication operates without data loss for 72 hours continuously, with automatic recovery from simulated failures within the specified time.
Source: System requirement


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

[User]
Expand requirement SRS-FUNC-005: "configuration persistence and validation" (Category: functional)
Project: CochleaMap CI Fitting Software | Cochlear Implant Fitting Software | Class C
Programming electrode mapping and stimulation parameters for cochlear implant sound processors. Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

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

[Assistant]
Description: The CochleaMap CI Fitting Software shall allow authorized users to configure operating parameters via USB programming cable and persist settings across power cycles.
Rationale: Configurable parameters allow the Cochlear Implant Fitting Software to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: All configurable parameters persist correctly across power cycles and reject out-of-range values with appropriate error messages.
Source: User need


[System] You are 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 GaitSense Walking Analysis, a Class B Gait Analysis Insole Firmware. Reference IEC 62304 Clauses 5.6.7, 5.7.5.
Instrumented insole firmware analyzing gait patterns and detecting asymmetries. Reports generated for orthopedic assessment.

[Assistant] Content: Test deliverables for the GaitSense Walking Analysis at Class B include the integration test report per Clause 5.6.7 and the system test report per Clause 5.7.5. Each report documents the test configuration, test procedures, results, and any deviations. The Gait Analysis Insole Firmware is accepted when all test cases pass and the traceability matrix shows complete coverage.


[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 DreamLog Sleep Monitor, a Class A Sleep Tracking Display App. Reference IEC 62304 Clause 5.2.2.
Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

[Assistant] Content: Interface requirements for the DreamLog Sleep Monitor specify the communication protocols, data formats, and timing constraints for each external interface of the Sleep Tracking Display App. The primary data acquisition interface uses BLE 5.2 with specified data rates and error 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 change control process for DialyFlow Dialysis Fluid Controller, a Class C Hemodialysis Fluid Controller Firmware. Reference IEC 62304 Clauses 8.2, 8.2.1.
Firmware controlling dialysate flow rates and composition in a hemodialysis machine. Fluid balance errors could be fatal.

[Assistant] Content: Changes to the DialyFlow Dialysis Fluid Controller software baseline require a documented change request approved before implementation. The change control process per Clause 8.2 includes impact assessment on safety, regression risk evaluation, and verification of the change before integration into the controlled baseline.


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

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

"In accordance with ISO 14971-2, verification activities include system testing."

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


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

[User]
Write a THREAT section on STRIDE mitigations traced to requirements for CogniTest Cognitive Assessment App, a Class B Cognitive Assessment Application. Reference IEC 62304 Clause 5.2.3.
Tablet app administering standardized cognitive screening tests and scoring results. Used by neuropsychologists in clinical settings.

[Assistant] Content: Threat-to-mitigation traceability for the CogniTest Cognitive Assessment App Cognitive Assessment Application is maintained per Clause 5.2.3. Each STRIDE threat is mapped to a security requirement, an implementation, and a verification test. This traceability ensures no identified threat lacks a corresponding software control.


[System] You are 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 CardioCloud ECG Analysis Service, a Class B Cloud ECG Analysis SaMD. Reference IEC 62304 Clauses 5.6.7, 5.7.5.
Cloud SaaS platform receiving 12-lead ECG recordings from clinics, running automated arrhythmia detection, and returning annotated results via FHIR API.

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

[User]
Write a SDP section on requirements verification approach for DermaAssist Skin Lesion Classifier, a Class B Skin Lesion Classification App. Reference IEC 62304 Clause 5.2.6.
Mobile app using a CNN to classify skin lesion images as benign/suspicious. Decision support requiring dermatologist confirmation.

[Assistant] Content: Requirements verification for the DermaAssist Skin Lesion Classifier is conducted per Clause 5.2.6 before the requirements baseline is established. The review confirms completeness, consistency, and testability. Any requirement failing these criteria is returned for rework before the Skin Lesion Classification App proceeds to design.


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

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

"The development plan references IEC 62304 Clause 5.7.6 and Clause 5.5.2.1 for the OxyPure Controller."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.7.6 and 5.5.2.1, neither of which exists. Clause 5.7 has 5.7.1 through 5.7.5 only. IEC 62304 has no four-level numbering. All clause references must be corrected.


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

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

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

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


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

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

"ISO 13485-2 Section 7.1 requires all software units to be verified."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 13485-2" which is incorrect. ISO 13485 has no Part 2. All references must be corrected.


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

[User]
Write a SRS section on operational context and user population for TrainCert Staff Certification Tracker, a Class A Training Certification System. Reference IEC 62304 Clause 5.2.2.
Web app tracking staff training certifications and renewal dates. Administrative HR tool for compliance tracking.

[Assistant] Content: The TrainCert Staff Certification Tracker operates as a Training Certification System where Tracking and reporting on staff training certifications and renewals. The software interfaces with external data sources and communicates via REST API, email notifications. The operational environment, user population, and regulatory context described here constrain the requirements that follow.


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

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

"Integration tests verify that components of the MedInventory interact correctly at each interface point."

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


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

[User]
Write a SDP section on change control and trend analysis for problems for RadView DICOM Viewer, a Class A Medical Image Viewer. Reference IEC 62304 Clauses 9.4, 9.6.
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 problem correction workflow routes all fixes through the change control process per Clause 9.4. Trend analysis per Clause 9.6 reviews accumulated problem reports at each phase gate to detect recurring defect patterns, common root causes, and areas of the Medical Image Viewer requiring additional verification attention.