[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: "real-time data presentation on REST API" (Category: functional)
Project: SupplyChain Procurement Portal | Supply Chain Procurement System | Class A
Managing procurement of medical supplies with approval tracking. Web portal for ordering medical supplies with approval workflows. Procurement and logistics only.

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

[Assistant]
Description: The SupplyChain Procurement Portal display shall present current readings on REST API within the specified maximum update latency.
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. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-DATA-002: "record keeping duration" (Category: data)
Project: InhaleSense Smart Inhaler Tracker | Smart Inhaler Adherence Tracker | Class A
Detecting inhaler actuation events and tracking medication adherence for asthma management. Firmware for a smart inhaler attachment detecting actuation events, tracking medication adherence, and syncing data to a mobile app and clinician portal.

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

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

"Software problem resolution follows ISO 14901 Clause 9."

[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 InfuSafe Controller (insulin infusion pump controller, Class C):

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

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


[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):

"Each software unit of the MedInventory shall have corresponding unit test cases with full branch coverage."

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


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

[User]
Write a SDP section on Class B classification justification and implications for InfuRate IV Flow Calculator, a Class B Infusion Rate Calculator. Reference IEC 62304 Clause 4.3.
Desktop calculator for IV infusion rates based on drug concentration, patient weight, and ordered dose. Clinical decision support tool.

[Assistant] Content: Under IEC 62304 Clause 4.3, the InfuRate IV Flow Calculator is classified as Safety Class B. The Infusion Rate Calculator can contribute to a hazardous situation through Calculating IV infusion rates from prescribed doses, concentrations, and patient parameters, but the identified hazards are mitigated by clinical workflow safeguards that prevent progression to serious injury or death. This classification drives the requirement for architectural design documentation and integration testing.


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

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

"Software safety classification is performed per IEC 62304-6 Clause 4.3."

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


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

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

"Maintenance activities follow IEC 62304-2 Clause 6."

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


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

[User]
Write a SDP section on test records and acceptance criteria for Class B for PressoTrack Blood Pressure Trending, a Class B Ambulatory Blood Pressure Monitor Firmware. Reference IEC 62304 Clauses 5.6.7, 5.7.5.
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 verification records comprise integration test results (Clause 5.6.7) and system test results (Clause 5.7.5). Pass criteria require every architectural interface exercised by at least one integration test and every SRS requirement covered by at least one system test. Anomalies are tracked in the problem resolution process per Clause 9.1.


[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 Class C classification justification and implications for BeamPlan Radiation Treatment Planner, a Class C Radiation Treatment Planning Software. Reference IEC 62304 Clause 4.3.
Desktop software calculating radiation treatment plans including beam angles, dose distribution, and organ-at-risk constraints.

[Assistant] Content: The BeamPlan Radiation Treatment Planner is classified as IEC 62304 Safety Class C per Clause 4.3, as malfunction of the Radiation Treatment Planning Software could directly contribute to serious injury or death. The software controls critical therapeutic parameters and has no independent hardware safety mechanism that fully mitigates the risk. This classification mandates the most rigorous lifecycle activities including detailed design, unit verification with MC/DC coverage, integration testing, and independent review.


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

[User]
Write a SRS section on data retention and integrity requirements for HandGrip Strength Dynamometer, a Class B Hand Dynamometer Firmware. Reference IEC 62304 Clause 5.2.2.
Digital hand dynamometer firmware measuring grip strength and fatigue over repeated trials for rehabilitation assessment.

[Assistant] Content: The HandGrip Strength Dynamometer data requirements define how the Hand Dynamometer Firmware stores, retrieves, and protects data acquired during Measuring hand grip strength and fatigue patterns for rehabilitation progress tracking. Requirements specify data format, retention duration, backup frequency, and the behavior when data corruption is detected.


[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 WasteTrack Biohazard Logger, a Class A Biohazard Waste Tracking App. Reference IEC 62304 Clause 5.2.2.
Mobile app scanning and logging biohazard waste container pickups. Tracks chain of custody for environmental compliance.

[Assistant] Content: Security requirements for the WasteTrack Biohazard Logger address authentication, data protection, and access control for the Biohazard Waste Tracking App. 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 an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-FUNC-003: "user-configurable operating parameters" (Category: functional)
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: The BSACalc Body Surface Area Tool shall allow authorized users to configure operating parameters via web form and persist settings across power cycles.
Rationale: Parameter flexibility is essential for the BSA Calculator Web App to meet varying clinical requirements across deployment sites.
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 change control process for SurgLog Procedure Documentation App, a Class A Surgical Documentation App. Reference IEC 62304 Clauses 8.2, 8.2.1.
Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

[Assistant] Content: Change control for the SurgLog Procedure Documentation App Surgical Documentation App follows Clause 8.2. Each change request is assessed for safety impact, assigned a priority, and tracked to closure. Changes to safety-related requirements or risk control measures require re-evaluation of the ISO 14971 risk analysis before implementation.


[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):

"Post-market activities are conducted as required by applicable regulations. Feedback mechanisms are established per best practices for the OxyPure Controller."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "best practices", "as required by" provide no project-specific information about the OxyPure Controller oxygen concentrator controller. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

[User]
Write a FMEA section on risk control measures and implementation for TransVent Transport Ventilator, a Class C Transport Ventilator Firmware. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Portable transport ventilator firmware for ambulance and helicopter use. Must maintain ventilation under vibration and altitude changes.

[Assistant] Content: Risk control measures for the TransVent Transport Ventilator Transport Ventilator Firmware are prioritized per Clause 7.2.1: inherently safe design first, then protective measures in software, then information for safety. Software-implemented controls per Clause 7.2.2 are expressed as verifiable requirements and traced to their originating hazard.


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

[User]
Write a SDP section on scope boundaries of the software system for WaterPure Quality Logger, a Class A Water Quality Data Logger. Reference IEC 62304 Clauses 5.1.1, 5.1.2.
Embedded system logging purified water system parameters (conductivity, TOC, flow rate) for pharmaceutical manufacturing compliance.

[Assistant] Content: Scope is limited to the WaterPure Quality Logger software items developed under this plan and released as a single configuration baseline. Peripherals, test jigs, and cloud infrastructure used during Continuous logging of purified water parameters for GMP compliance are addressed by separate system-level documentation and are not governed by IEC 62304 Clause 5.1.1 activities described herein.


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

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

"The ChemoCalc addresses IEC 62304 Clause 10.1 (data archival) 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 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):

"In accordance with IEC 62304-5, verification activities include system testing."

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


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

[User]
Write a TRACE section on risk control coverage verification for HydroRemind Hydration Tracker, a Class A Hydration Tracking Firmware. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

[Assistant] Content: Coverage analysis for risk controls in the HydroRemind Hydration Tracker 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 Hydration Tracking 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 StepTrack (wellness pedometer app, Class A):

"Compliance with IEC 62304 Clause 5.10 is demonstrated through automated regression testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.10 which does not exist. Clause 5 ends at 5.8. The reference must be corrected to a valid clause number.


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

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

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

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


[System] You are a regulatory 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 MedImage PACS Viewer, a Class A Web PACS Image Viewer. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Web-based PACS viewer enabling radiologists to review DICOM images with standard tools (windowing, measurement, MPR). View-only, no AI or diagnostic processing.

[Assistant] Content: Risk control measures for the MedImage PACS Viewer are defined per Clause 7.2.1 and implemented in software per Clause 7.2.2. Controls include input validation for data inputs, range checking on processed values, and timeout detection on DICOMweb WADO-RS. Each control is traced to a software requirement and verified through testing.


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

[User]
Write a SRS section on safety requirements for Class B for DermaLens Teledermatology Platform, a Class B Cloud Teledermatology SaMD. Reference IEC 62304 Clauses 5.2.2, 5.2.3.
Cloud platform enabling dermatologists to review patient-submitted skin images with AI-assisted triage scoring. Images uploaded from mobile app to cloud pipeline.

[Assistant] Content: The DermaLens Teledermatology Platform safety requirements address software contributions to hazardous situations identified for the Cloud Teledermatology SaMD. Risk control measures per Clause 5.2.3 include input validation, plausibility checks on smartphone camera (via mobile app), and alert generation when measured values exceed safe thresholds during AI-assisted triage scoring of skin lesion images submitted through a mobile teledermatology workflow.


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

[User]
Write a SRS section on safety requirements for Class A -- confirms no safety functions for SupplyChain Procurement Portal, a Class A Supply Chain Procurement System. Reference IEC 62304 Clauses 5.2.2, 5.2.3.
Web portal for ordering medical supplies with approval workflows. Procurement and logistics only.

[Assistant] Content: The SupplyChain Procurement Portal is classified as Safety Class A and contains no software-implemented safety functions. The Supply Chain Procurement System provides informational output only for Managing procurement of medical supplies with approval tracking and does not control any therapeutic function, generate clinical alarms, or make diagnostic decisions. No risk control measures are implemented in software per Clause 5.2.3.


[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 FactoryTemp Industrial Temperature Monitor, a Class A Industrial Temperature Monitoring Firmware. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Firmware monitoring factory floor temperatures from distributed thermocouple arrays. Logs data for process control compliance.

[Assistant] Content: Risk control measures for the FactoryTemp Industrial Temperature Monitor are defined per Clause 7.2.1 and implemented in software per Clause 7.2.2. Controls include input validation for K-type thermocouples (x16), range checking on processed values, and timeout detection on Modbus RTU. Each control is traced to a software requirement and verified through testing.


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

[User]
Write a SDP section on verification strategy for Class B -- integration and system testing for RespiRate Respiratory Monitor, a Class B Respiratory Rate Monitor Firmware. Reference IEC 62304 Clauses 5.6, 5.6.3, 5.7.
Wearable firmware monitoring respiratory rate via chest impedance. Displays rate and alerts on bradypnea/tachypnea.

[Assistant] Content: Verification of the RespiRate Respiratory Monitor 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 Respiratory Rate Monitor Firmware against all requirements in the SRS on nRF52840.


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

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

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

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


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

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

"In accordance with ISO 14971-1, verification activities include system testing."

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


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

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

"The PillRemind problem resolution process follows Clause 9. Problem reports are prepared per Clause 9.1, investigated per Clause 9.2, and resolved through the change control process per Clause 9.4. Trends are analyzed per Clause 9.6."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the PillRemind (medication reminder app, Class A). Standards references are accurate.


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

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

"Software changes to the CaloriePal are evaluated for risk impact per Clause 7.4. Each change request includes a risk assessment determining whether new hazards are introduced or existing risk controls are affected. Re-verification of affected risk controls is required before release."

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


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

[User]
Write a FMEA section on risk control verification for CardioRhythm ECG Analyzer, a Class B Single-Lead ECG Device Firmware. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Portable ECG device firmware acquiring single-lead ECG and classifying basic rhythm types. Incorrect classification could delay diagnosis.

[Assistant] Content: Verification of CardioRhythm ECG Analyzer risk controls per Clause 7.3.1 is performed as part of the applicable verification level for the safety class. Each verified control has a documented result per Clause 7.3.3, confirming the Single-Lead ECG Device Firmware meets the risk acceptability criteria.


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

[User]
Write a SDP section on change control and trend analysis for problems for VisitorPass Access Management, a Class A Visitor Management System. Reference IEC 62304 Clauses 9.4, 9.6.
Kiosk application for visitor registration and badge printing in hospital lobbies. Administrative access control.

[Assistant] Content: All VisitorPass Access Management problem corrections enter the change control process per Clause 9.4 before integration into the baseline. Trend analysis per Clause 9.6 tracks defect density, time-to-resolution, and defect category distribution across the Visitor Management System development lifecycle to drive process improvement.


[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 failure mode identification approach for NeoFeed Neonatal Feeding Pump, a Class C Neonatal Feeding Pump Firmware. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Syringe pump firmware for precise enteral feeding in NICU patients. Flow accuracy is critical for extremely low birth weight infants.

[Assistant] Content: Failure modes for each NeoFeed Neonatal Feeding Pump software function are identified by systematic analysis of data flow paths, processing algorithms, and interface transactions. For each function, the analysis considers: incorrect output, missing output, output at wrong time, and unexpected output. Causes include coding defects, resource exhaustion, race conditions, and corrupted input from linear encoder.


[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 AnesBot Automated Anesthesia Controller, a Class C Automated Anesthesia Delivery Software. Reference IEC 62304 Clauses 8.2, 8.2.1.
Software controlling target-controlled infusion of propofol based on BIS monitoring. Overdose could cause respiratory arrest.

[Assistant] Content: Changes to the AnesBot Automated Anesthesia 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 ThermoGuard (body temperature logger, Class A):

"Unit testing for the ThermoGuard 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 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: "measurement record integrity" (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: The SeismicWatch Earthquake Early Warning shall validate the integrity of stored data using checksums, detecting and reporting any corruption of measurement records.
Rationale: Data integrity mechanisms ensure measurement records retrieved from the Seismic Early Warning Firmware are trustworthy for clinical review.
Priority: Mandatory
Acceptance Criterion: Intentionally corrupted records are detected and flagged with 100% detection rate across 100 injected corruption events.
Source: System requirement


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

[User]
Write a SDP section on risk control verification and traceability for RespiRate Respiratory Monitor, a Class B Respiratory Rate Monitor Firmware. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Wearable firmware monitoring respiratory rate via chest impedance. Displays rate and alerts on bradypnea/tachypnea.

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


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

[User]
Write a SAD section on architecture verification scope for AnesBot Automated Anesthesia Controller, a Class C Automated Anesthesia Delivery Software. Reference IEC 62304 Clauses 5.3.1, 5.3.6.
Software controlling target-controlled infusion of propofol based on BIS monitoring. Overdose could cause respiratory arrest.

[Assistant] Content: The architecture described in this document is verified per Clause 5.3.6, confirming that all software requirements are addressed by at least one software item. Verification also confirms that the AnesBot Automated Anesthesia Controller Automated Anesthesia Delivery Software architecture supports the defined interfaces and does not introduce new hazards.


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

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

"Verification activities are conducted as needed to ensure quality and compliance. Testing approaches are selected based on best practices for the oxygen concentrator controller."

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


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

[User]
Write a THREAT section on threat model data flow decomposition for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clause 5.2.2.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: Threat model decomposition for the CochleaMap CI Fitting Software uses data flow diagrams at two levels of detail: a context diagram showing the Cochlear Implant Fitting Software and all external entities, and a level-1 diagram showing internal processes and data stores. Each data flow crossing a trust boundary is subject to STRIDE analysis.


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

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

"IEC 62304:2015 Section 5.2 requires all software units to be verified."

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


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

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

"For the Class A BloodBank Manager, verification is limited to system-level test execution per Clause 5.7. The developer performs verification. No independent review is required. Test records include pass/fail results and defect references."

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


[System] You are 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 A -- system testing only for PostureGuard Desk Monitor, a Class A Posture Wellness Display Software. Reference IEC 62304 Clauses 5.7, 5.7.1.
USB webcam software that estimates sitting posture and displays a wellness score. No ergonomic prescriptions or clinical assessments.

[Assistant] Content: The verification plan for the PostureGuard Desk Monitor Posture Wellness Display Software is scoped to system testing in accordance with Clause 5.7. Test procedures confirm the software meets each documented requirement, including boundary conditions and error handling. The Class A safety classification means unit-level and integration verification activities per Clauses 5.5 and 5.6 are not part of the verification plan.


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

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

"SOUP functional requirements for the HydroLog are specified per Clause 5.3.3."

[Assistant]
Verdict: FAIL
Note: Content mandates architectural design documentation for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Architectural design (Clause 5.3) is not required for Class A.


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

[User]
Write a SRS section on safety requirements for Class B for DoseCalc Medication Calculator, a Class B Medication Dose Calculator App. Reference IEC 62304 Clauses 5.2.2, 5.2.3.
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 Class B safety requirements include controls for data integrity, range validation, and fail-safe behavior when external system communication is lost. Each requirement traces to a hazard identified in the risk analysis and is verified during integration or system testing of the Medication Dose Calculator App.


[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 VitalBoard Patient Summary, a Class A Patient Summary Dashboard. Reference IEC 62304 Clause 7.1.1.
Dashboard displaying patient vital signs history retrieved from the EMR. View-only with no alerting or trend analysis.

[Assistant] Content: The VitalBoard Patient Summary 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 Patient Summary Dashboard and confirms that all failure effects are limited to loss of informational functionality.


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

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

"Software release criteria for the AutoDose TPN include completeness of all Class C deliverables (Clause 5.8.1), correct version identification (Clause 5.8.2), documented residual anomalies (Clause 5.8.4), and release approval by the quality representative."

[Assistant]
Verdict: PASS
Note: Content correctly specifies full Class C rigor. 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 SleepWell (sleep quality display app, Class A):

"Compliance with IEC 62304 Clause Annex B.3 (data archival) and Clause 11.1 (deployment validation) is demonstrated."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses Annex B.3 and 11.1, neither of which exists. IEC 62304 annexes are not cited as requirements. IEC 62304 has no Clause 11. All clause 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 SleepWell (sleep quality display app, Class A):

"Architecture for the SleepWell transforms requirements into a software architecture per Clause 5.3.1. Interfaces between software items are defined per Clause 5.3.2. SOUP functional requirements are specified per Clause 5.3.3. The architecture is verified per Clause 5.3.6."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the SleepWell (sleep quality display app, Class A). Standards references are accurate.


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

[User]
Write a THREAT section on STRIDE threat categories applied to the device for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clause 5.2.2.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: The CochleaMap CI Fitting Software threat analysis applies STRIDE to every trust boundary crossing in the Cochlear Implant Fitting Software. Each identified threat is rated for impact and likelihood, and mitigation controls are defined. Mitigations are traced to security requirements in the SRS and verified through security testing per IEC 81001-5-1:2021.


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

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

"The BloodBank Manager verification strategy mandates unit testing with 90% statement coverage, integration testing of all component interfaces, and system-level testing."

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


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

[User]
Write a SDP section on problem reporting and investigation for VitalPulse SpO2 Monitor, a Class B Pulse Oximeter Firmware. Reference IEC 62304 Clauses 9.1, 9.2.
Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

[Assistant] Content: Problems identified in the VitalPulse SpO2 Monitor are reported per Clause 9.1 with anomaly description, affected component, severity, and reproduction steps. Investigation per Clause 9.2 determines root cause and impact. Relevant parties are advised per Clause 9.3 when the problem affects the Pulse Oximeter Firmware safety or regulatory compliance.


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

[User]
Write a SDP section on configuration identification approach for ConsentView Informed Consent Archive, a Class A Consent Document Viewer. Reference IEC 62304 Clauses 8.1, 8.1.1.
Web portal for patients and staff to view signed informed consent documents. Read-only document viewer.

[Assistant] Content: Configuration items for the ConsentView Informed Consent Archive Consent Document Viewer are identified and placed under version control per Clause 8.1. The configuration baseline includes all items needed to reproduce the released software: source code, build scripts, third-party libraries, and the documentation set.


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

[User]
Write a SDP section on risk control verification and traceability for SunGuard UV Index Display, a Class A UV Exposure Display Firmware. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Wearable UV index monitor with an OLED display showing current UV exposure level. Informational only, no sunburn prevention claims.

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


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

[User]
Write a SRS section on user interaction requirements for TempWatch Body Temperature Logger, a Class A Temperature Logging Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware for a wearable temperature patch that logs skin temperature over 24 hours and displays trends. No fever detection or alerts.

[Assistant] Content: User interaction requirements for the TempWatch Body Temperature Logger define the input mechanisms, display elements, and feedback provided by the Temperature Logging Firmware during Passive logging and display of skin temperature trends for personal interest. Requirements specify the information presented to the user, the actions available, and the system response to each user action.


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

[User]
Write a SAD section on architectural overview for Class B for ChestAI Pulmonary Nodule Detector, a Class B AI Pulmonary Nodule Detection SaMD. Reference IEC 62304 Clauses 5.3.1, 5.3.2.
Cloud AI SaMD analyzing chest CT scans to detect and measure pulmonary nodules, providing CAD overlay for radiologist review. FDA De Novo pathway.

[Assistant] Content: The ChestAI Pulmonary Nodule Detector AI Pulmonary Nodule Detection SaMD is structured as a three-tier architecture: data acquisition, processing, and presentation. Interfaces between tiers are defined per Clause 5.3.2 and serve as integration test points. The architecture supports Python (PyTorch + MONAI) + TypeScript (viewer) implementation on Azure Kubernetes + GPU nodes + OHIF viewer.


[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 DermaLens Teledermatology Platform, a Class B Cloud Teledermatology SaMD. Reference IEC 62304 Clause 5.3.2.
Cloud platform enabling dermatologists to review patient-submitted skin images with AI-assisted triage scoring. Images uploaded from mobile app to cloud pipeline.

[Assistant] Content: Interfaces between DermaLens Teledermatology Platform software items are specified per Clause 5.3.2 with defined data types, calling conventions, error return values, and thread safety requirements. The Cloud Teledermatology SaMD internal interfaces include the smartphone camera (via mobile app) abstraction layer, the processing API, and the presentation layer interface.


[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 RemotICU Continuous Monitoring Hub, a Class B Edge-to-Cloud ICU Monitoring Gateway. Reference IEC 62304 Clause 4.3.
Edge gateway collecting data from bedside monitors (SpO2, HR, BP, ventilator) and streaming to cloud for trending, alerting, and tele-ICU review.

[Assistant] Content: Clause 4.3 of IEC 62304 requires classification of the RemotICU Continuous Monitoring Hub 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 Edge-to-Cloud ICU Monitoring Gateway and is subject to re-evaluation if the intended use or risk profile changes per Clause 5.2.4.


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

[User]
Write a SDP section on milestones and phase transition criteria for InsuPrecise Insulin Pump Controller, a Class C Insulin Pump Controller Firmware. Reference IEC 62304 Clause 5.1.1.
Embedded firmware controlling insulin delivery in a patch-type insulin pump. Incorrect dosing could cause severe hypoglycemia or diabetic ketoacidosis.

[Assistant] Content: The InsuPrecise Insulin Pump Controller development schedule is anchored to formal milestones with documented transition criteria. Progress is measured against these gates rather than calendar dates, ensuring the Insulin Pump Controller Firmware meets all quality and safety requirements before advancing to the next lifecycle phase.


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

[User]
Write a SDP section on configuration identification approach for PulmoCheck Spirometry Analyzer, a Class B Spirometry Analysis Software. Reference IEC 62304 Clauses 8.1, 8.1.1.
Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

[Assistant] Content: All artifacts produced during PulmoCheck Spirometry Analyzer development are placed under configuration control per Clause 8.1. Configuration items include source files, build definitions, documentation, test scripts, and SOUP component packages. Each item is uniquely identified by a repository path and immutable revision hash.


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

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

"Per IEC 62304 Clause 5.7, system testing is performed. Per IEC 62304 Clause 5.7, the system is tested. Per IEC 62304 Clause 5.7, system-level verification is conducted. Per IEC 62304 Clause 5.7, the LabView Portal undergoes system testing."

[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 LabView Portal.


[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: "data retention period" (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: The HeartView Resting HR Display shall retain measurement data in non-volatile storage for the specified minimum retention period, after which data may be overwritten.
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 SRS section on user interaction requirements for CardioCloud ECG Analysis Service, a Class B Cloud ECG Analysis SaMD. Reference IEC 62304 Clause 5.2.2.
Cloud SaaS platform receiving 12-lead ECG recordings from clinics, running automated arrhythmia detection, and returning annotated results via FHIR API.

[Assistant] Content: Interaction requirements for the CardioCloud ECG Analysis Service specify all user-facing behaviors of the Cloud ECG Analysis SaMD: screen layouts, navigation flows, alarm presentation (if applicable), and error messaging. Each interaction requirement includes the trigger condition, the expected system response, and the acceptance criteria for verification.


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

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

"Statement coverage of 90% and branch coverage of 80% are mandatory for the LabView Portal."

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


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

[User]
Expand requirement SRS-PERF-002: "resource utilization limits" (Category: performance)
Project: BillingBridge Claims Processor | Claims Processing Service | Class A
Automated processing and submission of insurance claims. Backend service processing insurance claims from the hospital billing system. Financial processing only, no clinical data.

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

[Assistant]
Description: The BillingBridge Claims Processor memory footprint on Cloud (AWS) shall remain within specified limits under worst-case operational scenarios.
Rationale: Exceeding memory limits could cause undefined behavior in the Claims Processing Service, potentially affecting safety.
Priority: Mandatory
Acceptance Criterion: Memory profiling under stress conditions shows stable allocation with no leaks over a 72-hour test period.
Source: System requirement


[System] You are 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 LabView Portal (read-only lab results viewer, Class A):

"REQ-SRS-034: The LabView Portal shall complete self-test diagnostics within 5 seconds of power-on and report any detected hardware faults. Acceptance criterion: inject simulated hardware faults and verify detection within the time limit. Priority: Mandatory. Source: System requirement."

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


[System] You are a 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 error propagation and data integrity in the pipeline for PathCloud AI Histology Analyzer, a Class B Cloud SaMD Histopathology Analysis Platform. Reference IEC 62304 Clause 5.3.2.
Cloud-hosted SaMD analyzing whole-slide histology images with deep learning to flag suspicious regions for pathologist review. Runs as a multi-tenant SaaS.

[Assistant] Content: Data integrity in the PathCloud AI Histology Analyzer pipeline is maintained through validation at every software item boundary. The architecture specifies error codes, timeout behavior, and recovery actions for each interface. The Cloud SaMD Histopathology Analysis Platform logs all data integrity failures for post-deployment analysis.


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

[User] Is unit testing required for Class A under IEC 62304?

[Assistant] No. Unit testing (Clause 5.5) is NOT required for Class A software under IEC 62304. Class A requires only system-level testing (Clause 5.7). Similarly, integration testing (Clause 5.6) and detailed design (Clause 5.4) are not required for Class A. The rationale is that Class A software cannot contribute to a hazardous situation.


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

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

"The BloodBank Manager addresses IEC 62304 Clause 11.1 for data archival and Clause 5.0 for post-market surveillance."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 11.1 and 5.0, neither of which exists. IEC 62304 has no Clause 11. Clause 5 starts at 5.1. All clause 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 BloodBank Manager (blood bank inventory system, Class A):

"Comprehensive unit tests shall be developed for every software module of the BloodBank Manager."

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


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

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

"For the Class A LabView Portal, verification is limited to system-level test execution per Clause 5.7. The developer performs verification. No independent review is required. Test records include pass/fail results and defect references."

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


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

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

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

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


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

[User]
Write a SAD section on external interface architecture for InfuRate IV Flow Calculator, a Class B Infusion Rate Calculator. Reference IEC 62304 Clause 5.3.2.
Desktop calculator for IV infusion rates based on drug concentration, patient weight, and ordered dose. Clinical decision support tool.

[Assistant] Content: External interface architecture for the InfuRate IV Flow Calculator Infusion Rate Calculator wraps each physical interface in an abstraction layer. This design per Clause 5.3.2 decouples the application logic from hardware specifics of Windows/macOS desktop, enabling integration testing with simulated interfaces.


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

[User]
Expand requirement SRS-PERF-002: "resource utilization limits" (Category: performance)
Project: CogniTest Cognitive Assessment App | Cognitive Assessment Application | Class B
Administering and scoring standardized cognitive screening tests for clinical neuropsychological assessment. Tablet app administering standardized cognitive screening tests and scoring results. Used by neuropsychologists in clinical settings.

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 CogniTest Cognitive Assessment App shall operate within the specified RAM and flash memory budget on the iPadOS platform, including all runtime allocations.
Rationale: Memory constraints are fixed by the iPadOS 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 an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a FMEA section on failure mode identification approach for RetinaScan Diabetic Retinopathy Screener, a Class B Retinal Screening Software. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Desktop software analyzing retinal fundus images to detect signs of diabetic retinopathy for ophthalmologist review.

[Assistant] Content: The RetinaScan Diabetic Retinopathy Screener failure mode identification per Clause 7.1.2 uses a function-by-function analysis of the Retinal Screening Software. Each software function is examined for potential failure modes: omission, commission, early, late, and value errors. Potential causes per Clause 7.1.2 include design defects, SOUP anomalies per Clause 7.1.3, and environmental factors.


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

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

"Risk control measures are implemented per ISO 14971:2020 Clause 7."

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


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

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

"Safety classification of the RadView DICOM is performed per Clause 4.3. The quality management system meets Clause 4.1. Risk management is applied per Clause 4.2 in conjunction with ISO 14971:2019."

[Assistant]
Verdict: PASS
Note: Content correctly references ISO 14971:2019. Standards references are accurate.


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

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

"The RadBeam Planner software architecture defines three software items with documented interfaces per Clause 5.3.2. Data formats, protocols, and error handling are specified for each interface. SOUP components are identified per Clause 5.3.3."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the RadBeam Planner (radiation therapy planning system, Class C). Standards references are accurate.


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

[User]
Write a SDP section on internal SOPs and procedures for NutriCalc TPN Formulation Tool, a Class B TPN Formulation Calculator. Reference IEC 62304 Clause 5.1.2.
Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

[Assistant] Content: Company-internal standard operating procedures supplement the international standards for the NutriCalc TPN Formulation Tool project. SOP-010 through SOP-013 address development planning, risk management, configuration management, and verification planning. All SOPs are part of the ISO 13485 quality management system and are binding on the TPN Formulation Calculator development team.


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

[User]
Write a SDP section on problem reporting and investigation for GrowthChart Pediatric Viewer, a Class A Growth Chart Display App. Reference IEC 62304 Clauses 9.1, 9.2.
Web app displaying pediatric growth charts with WHO/CDC percentile curves. Plots measurements, no diagnostic interpretation.

[Assistant] Content: The GrowthChart Pediatric Viewer problem reporting process per Clause 9.1 captures all software anomalies with sufficient detail for reproduction and root cause investigation. Clause 9.2 investigation assesses whether the problem represents a safety risk, determines the affected scope within the Growth Chart Display App, and identifies the corrective action required.


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

[User]
Write a SRS section on resource constraints and scalability for LabStream LIS Middleware, a Class A Laboratory Information Middleware. Reference IEC 62304 Clause 5.2.2.
Middleware software connecting laboratory analyzers to the hospital LIS. Routes results, applies auto-validation rules, and flags critical values.

[Assistant] Content: Resource requirements for the LabStream LIS Middleware specify maximum memory utilization, persistent storage consumption, and processor loading on Linux server (Docker). The Laboratory Information Middleware must operate within these constraints under worst-case conditions without degradation of safety-relevant functions.


[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):

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

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


[System] You are an IEC 62304 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 ECGInsight Rhythm Interpreter, a Class B ECG Interpretation Service. Reference IEC 62304 Clauses 5.2.2, 5.2.3.
Cloud service analyzing 12-lead ECG recordings and generating preliminary rhythm interpretations for physician review.

[Assistant] Content: Safety requirements for the ECGInsight Rhythm Interpreter implement the risk control measures identified in the ISO 14971 analysis per Clause 5.2.3. The Class B ECG Interpretation Service includes software-implemented controls for input data validation, range checking, and communication integrity verification. Each safety requirement is traced to the originating hazard.


[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: "safety classification confirmation for Class A" (Category: safety)
Project: WasteTrack Biohazard Logger | Biohazard Waste Tracking App | Class A
Logging and tracking biohazard waste container chain of custody. Mobile app scanning and logging biohazard waste container pickups. Tracks chain of custody for environmental compliance.

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

[Assistant]
Description: The WasteTrack Biohazard Logger software shall not implement any function that could directly control a therapeutic output, modify a diagnostic conclusion, or trigger a clinical alert, consistent with its Class A classification.
Rationale: Confirming the absence of safety-relevant functions validates the Class A classification under IEC 62304 Clause 4.3.
Priority: Mandatory
Acceptance Criterion: Architecture review demonstrates complete absence of safety-critical software functions in the Biohazard Waste Tracking App.
Source: Regulatory


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

[User]
Write a SRS section on baseline security requirements for SupplyChain Procurement Portal, a Class A Supply Chain Procurement System. Reference IEC 62304 Clause 5.2.2.
Web portal for ordering medical supplies with approval workflows. Procurement and logistics only.

[Assistant] Content: The SupplyChain Procurement Portal security requirements cover confidentiality, integrity, and availability of the Supply Chain Procurement System and its data per IEC 81001-5-1:2021. Requirements specify access control mechanisms, encryption for data at rest and in transit, session management, and audit logging.


[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):

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

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


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

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

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

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


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

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

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

[Assistant]
Description: The GlucoSpot Continuous Glucose Display shall communicate with the primary sensor via BLE 5.0 (CGM receiver), implementing error detection and recovery for communication failures.
Rationale: Reliable sensor communication is the foundation of the CGM Display App data acquisition pipeline.
Priority: Mandatory
Acceptance Criterion: Error injection tests confirm 100% detection rate for corrupted frames and recovery within specified timeout.
Source: System requirement


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

[User]
Write a THREAT section on STRIDE threat categories applied to the device for AnesBot Automated Anesthesia Controller, a Class C Automated Anesthesia Delivery Software. Reference IEC 62304 Clause 5.2.2.
Software controlling target-controlled infusion of propofol based on BIS monitoring. Overdose could cause respiratory arrest.

[Assistant] Content: The STRIDE analysis for the AnesBot Automated Anesthesia Controller Automated Anesthesia Delivery Software evaluates six threat categories at each trust boundary: Spoofing (unauthorized entity impersonation), Tampering (data modification in transit or at rest), Repudiation (undetectable actions), Information Disclosure (data leakage), Denial of Service (availability disruption), and Elevation of Privilege (unauthorized capability access).


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

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

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

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


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

[User]
Write a SAD section on SOUP risk evaluation and anomaly management for AuditTrail QMS Event Logger, a Class A QMS Audit Trail Service. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Microservice capturing and storing quality management system audit events. Logging and reporting only.

[Assistant] Content: Risk evaluation of SOUP in the AuditTrail QMS Event Logger follows Clause 7.1.3. Published anomaly lists are reviewed for each SOUP item deployed in the QMS Audit Trail Service. Anomalies relevant to Capturing and archiving QMS events for regulatory audit trails are entered into the risk management file, and mitigations are implemented where the residual risk is unacceptable.


[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: "computational accuracy requirement" (Category: performance)
Project: RetinaStim Visual Prosthesis Controller | Retinal Prosthesis Controller Firmware | Class C
Processing camera input and driving retinal implant electrode stimulation patterns for artificial vision. Firmware driving a retinal implant electrode array based on camera input processing. Stimulation errors could cause retinal damage.

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

[Assistant]
Description: Output accuracy of the Retinal Prosthesis Controller Firmware shall meet or exceed the specified tolerance for all measurement parameters across operating conditions.
Rationale: Inaccurate output from the Retinal Prosthesis Controller Firmware could lead to incorrect clinical actions, making accuracy a safety-critical requirement.
Priority: Mandatory
Acceptance Criterion: Statistical analysis of 500 measurements shows mean error within tolerance and standard deviation within specified limits.
Source: Regulatory


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

[User]
Expand requirement SRS-SEC-001: "access control and authorization" (Category: security)
Project: NeoFeed Neonatal Feeding Pump | Neonatal Feeding Pump Firmware | Class C
Precise enteral feeding delivery for neonatal patients with sub-milliliter accuracy. Syringe pump firmware for precise enteral feeding in NICU patients. Flow accuracy is critical for extremely low birth weight infants.

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 NeoFeed Neonatal Feeding Pump, with credential validation before granting access.
Rationale: Access control prevents unauthorized modification of the Neonatal Feeding Pump Firmware operating parameters.
Priority: Mandatory
Acceptance Criterion: Brute-force protection activates after the specified number of failed authentication attempts.
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 hazard identification for the specific device for WeightAlert Neonatal Scale, a Class B Neonatal Scale Firmware. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

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


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

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

"Software safety classification is performed per applicable regulatory requirements. The classification drives appropriate lifecycle activities and documentation."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "generic phrasing" provide no project-specific information about the HydroLog hydration tracking wellness app. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


[System] You are a 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: "safety classification confirmation for Class A" (Category: safety)
Project: DreamLog Sleep Monitor | Sleep Tracking Display App | Class A
Visualizing sleep quality data for personal wellness awareness. Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

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

[Assistant]
Description: The Sleep Tracking Display App software functions are limited to informational display and data presentation, with no capability to influence clinical decisions or therapeutic actions.
Rationale: The Class A classification of the Sleep Tracking Display App depends on the software having no path to contribute to a hazardous situation.
Priority: Mandatory
Acceptance Criterion: Code review confirms no software path exists that controls therapeutic outputs, modifies diagnostic results, or generates clinical alerts.
Source: Regulatory


[System] You are a 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 PainScale Digital Assessment Tool, a Class B Pain Assessment Tool. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Web app for standardized pain assessment using validated scales (VAS, NRS, McGill). Records longitudinal pain data for treatment monitoring.

[Assistant] Content: The PainScale Digital Assessment Tool 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 Pain Assessment Tool.


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

[User] Does IEC 62366-1:2015+AMD1:2020 exist?

[Assistant] Yes. IEC 62366-1:2015+AMD1:2020 is the current edition of the usability engineering standard for medical devices. Note: this standard does have a Part 1, and IEC 62366-2 exists as a technical report with guidance.


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

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

[Assistant] Content: The TriageAI Emergency Triage Assistant data flow begins at the input interface and terminates at the user-facing output. Intermediate processing stages -- including validation, filtering, and computation -- are implemented as separate software items with defined interfaces per Clause 5.3.2. The ED Triage Decision Support App data flow is documented to support traceability and integration testing.