[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):

"Applicable standards for the PillRemind are: IEC 62304:2006+AMD1:2015 for the software development lifecycle, ISO 14971:2019 for risk management, and ISO 13485:2016 for the quality management system. No sub-part standards are referenced as IEC 62304 and ISO 14971 are each single-part standards."

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


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

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

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

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


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

[User]
Expand requirement SRS-DATA-001: "stored data corruption detection" (Category: data)
Project: 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 shall validate the integrity of stored data using checksums, detecting and reporting any corruption of measurement records.
Rationale: Corrupted data must be identified to prevent clinical decisions based on unreliable measurements.
Priority: Mandatory
Acceptance Criterion: Integrity check correctly identifies all corrupted records with zero false positives on uncorrupted data.
Source: System requirement


[System] You are a regulatory 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):

"Verification planning for the HydroLog scopes testing to system level only, consistent with Class A requirements. The verification plan references Clause 5.7 and defines acceptance criteria for each software requirement. Code coverage analysis is not required and is not included in the plan."

[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 SRS section on baseline security requirements for ClinTrial EDC Platform, a Class A Clinical Trial EDC Web Platform. Reference IEC 62304 Clause 5.2.2.
Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

[Assistant] Content: The ClinTrial EDC Platform Clinical Trial EDC Web Platform implements security controls per IEC 81001-5-1:2021: user authentication, role-based access control, encrypted storage, encrypted communications, and event logging. Security requirements are verified through system testing and documented in the security test report.


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

[User]
Write a SDP section on configuration identification approach for LabView Results Portal, a Class A Laboratory Results Viewer. Reference IEC 62304 Clauses 8.1, 8.1.1.
Web application displaying laboratory test results retrieved from the hospital LIS. Read-only viewer with no result interpretation or flagging.

[Assistant] Content: Configuration items for the LabView Results Portal Laboratory Results 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 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

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

"Risk management for the ThermoGuard follows Clause 7. Software items contributing to hazardous situations are identified per Clause 7.1.1. Risk control measures are defined per Clause 7.2.1 and verified per Clause 7.3.1. Traceability is documented per Clause 7.3.2."

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


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

[User]
Write a SDP section on hazard identification for the specific device for PedDose Pediatric Dosing App, a Class B Pediatric Dosing Calculator App. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Mobile reference app for pediatric drug dosing with weight-based calculations and age-specific ranges.

[Assistant] Content: Hazard identification for the PedDose Pediatric Dosing App per Clause 7.1.2 considers all software functions that could contribute to patient harm. Identified causes include incorrect sensor data processing, loss of communication on local drug database, and failure to detect out-of-range conditions during Weight-based pediatric dose calculations with age-appropriate range checking.


[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):

"Verification of the BloodBank Manager requires peer review of all design documents by an independent quality assurance reviewer prior to implementation."

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


[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):

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

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


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

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

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

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


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

[User] Can I cite ISO 13485:2016 in my documentation?

[Assistant] Yes. ISO 13485:2016 is the current edition of the medical device quality management systems standard.


[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 CleanRoom Particle Counter Logger, a Class A Cleanroom Environmental Logger. Reference IEC 62304 Clauses 9.4, 9.6.
Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

[Assistant] Content: All CleanRoom Particle Counter Logger 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 Cleanroom Environmental Logger development lifecycle to drive process improvement.


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

[User]
Expand requirement SRS-SEC-002: "access control and authorization" (Category: security)
Project: VitalPulse SpO2 Monitor | Pulse Oximeter Firmware | Class B
Continuous monitoring of blood oxygen saturation and pulse rate with clinical alarms. Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

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 VitalPulse SpO2 Monitor shall require authentication before allowing modification of device configuration parameters via I2C.
Rationale: Unauthorized configuration changes to the Pulse Oximeter Firmware could compromise its intended function or patient safety.
Priority: Mandatory
Acceptance Criterion: Configuration modification is rejected when attempted without valid credentials, verified across all configurable parameters.
Source: Risk control


[System] You are a regulatory 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):

"Integration testing validates the interaction between all StepTrack software components."

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


[System] You are a regulatory 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):

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

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


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

[User]
Write a SDP section on development platform and build infrastructure for SupplyChain Procurement Portal, a Class A Supply Chain Procurement System. Reference IEC 62304 Clause 5.1.4.
Web portal for ordering medical supplies with approval workflows. Procurement and logistics only.

[Assistant] Content: The SupplyChain Procurement Portal is developed in TypeScript/React targeting the Web SPA platform. Source code is maintained under version control with branching and tagging conventions defined in SOP-012. Build automation ensures reproducible compilation, and all toolchain versions are recorded as part of the configuration management baseline.


[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 PowerTrack UPS Monitor, a Class A UPS Monitoring Software. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

[Assistant] Content: Risk control coverage analysis for the PowerTrack UPS Monitor per Clause 7.3.2 confirms that every software-implemented risk control has a linked verification result demonstrating its effectiveness. Any risk control without verification evidence is treated as a critical gap blocking release of the UPS Monitoring Software.


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

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

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

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


[System] You are 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):

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

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


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

[User]
Expand requirement SRS-INTF-002: "clinical system integration interface" (Category: interface)
Project: FactoryTemp Industrial Temperature Monitor | Industrial Temperature Monitoring Firmware | Class A
Continuous monitoring and logging of factory floor temperatures for process control. Firmware monitoring factory floor temperatures from distributed thermocouple arrays. Logs data for process control 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 Industrial Temperature Monitoring Firmware shall support bidirectional data exchange with external systems over Modbus RTU.
Rationale: External system connectivity is required for the Industrial Temperature Monitoring Firmware to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


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

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

"The lifecycle processes for the DialysisGuard comply with IEC 62304-2."

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


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

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

"Cybersecurity considerations are addressed as applicable to the diabetic retinopathy screening AI. Controls are implemented following industry best practices and guidance."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "best practices", "as applicable" provide no project-specific information about the RetinaScan Pro diabetic retinopathy screening AI. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

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

"Architecture for the RetinaScan Pro 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 RetinaScan Pro (diabetic retinopathy screening AI, Class B). Standards references are accurate.


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

[User]
Write a SDP section on comprehensive deliverables list for Class C for ChemoFlow Infusion Controller, a Class C Chemotherapy Infusion Pump Firmware. Reference IEC 62304 Clause 5.1.8.
Firmware for a chemotherapy infusion pump controlling precise drug delivery rates. Dosing errors could be life-threatening.

[Assistant] Content: The ChemoFlow Infusion Controller Chemotherapy Infusion Pump Firmware requires the maximum documentation set under IEC 62304 Class C. Deliverables include planning documents (SDP), requirements (SRS), design documents (SAD, Detailed Design), verification records (unit, integration, and system test reports with coverage metrics), the traceability matrix, and the risk management file. Every deliverable is independently reviewed and approved.


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

[User]
Write a SDP section on requirements elicitation and documentation for InfuRate IV Flow Calculator, a Class B Infusion Rate Calculator. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Desktop calculator for IV infusion rates based on drug concentration, patient weight, and ordered dose. Clinical decision support tool.

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


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

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

[Assistant] Content: This Software Requirements Specification defines the functional, performance, and interface requirements for the CardioRhythm ECG Analyzer Single-Lead ECG Device Firmware. Requirements are derived from system requirements, the risk management file, and stakeholder needs analysis per IEC 62304 Clause 5.2.1. Each requirement is uniquely identified, prioritized, and traceable to its source.


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

[User]
Expand requirement SRS-PERF-002: "output precision and accuracy" (Category: performance)
Project: PulmoCheck Spirometry Analyzer | Spirometry Analysis Software | Class B
Analysis and interpretation of spirometry test data with predicted value comparison. Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

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

[Assistant]
Description: The PulmoCheck Spirometry Analyzer shall maintain measurement accuracy within the specified tolerance across the full operating range of the pneumotachograph.
Rationale: Inaccurate output from the Spirometry Analysis Software could lead to incorrect clinical actions, making accuracy a safety-critical requirement.
Priority: Mandatory
Acceptance Criterion: Accuracy verified against a calibrated reference across the full measurement range, with all readings within tolerance for 200+ test points.
Source: Regulatory


[System] You are an IEC 62304 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):

"The RadView DICOM software architecture per Clause 5.3 decomposes the system into software items with documented interfaces."

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

[User]
Expand requirement SRS-FUNC-003: "measurement data archival" (Category: functional)
Project: LabView Results Portal | Laboratory Results Viewer | Class A
Read-only display of laboratory test results for clinician reference. Web application displaying laboratory test results retrieved from the hospital LIS. Read-only viewer with no result interpretation or flagging.

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

[Assistant]
Description: The LabView Results Portal shall log measurement data with timestamps to non-volatile storage and provide a mechanism to retrieve logged data via HL7 FHIR API.
Rationale: Persistent measurement records enable post-hoc analysis and meet regulatory requirements for data retention.
Priority: Desirable
Acceptance Criterion: Data retrieval produces complete, uncorrupted records for the full specified retention period.
Source: User need


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

[User]
Expand requirement SRS-FUNC-006: "user-configurable operating parameters" (Category: functional)
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: Configuration changes to the DreamLog Sleep Monitor shall be validated against allowed ranges before acceptance and persisted to survive power loss.
Rationale: Parameter flexibility is essential for the Sleep Tracking Display 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 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 for the AutoDose TPN follows Clause 5.8. Completeness is ensured per Clause 5.8.1, version identification per Clause 5.8.2, and known residual anomalies are documented per Clause 5.8.4 and evaluated per Clause 5.8.5."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the AutoDose TPN (total parenteral nutrition calculator, Class C). Standards references are accurate.


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

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

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

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


[System] You are 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 CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: The CochleaMap CI Fitting Software failure mode identification per Clause 7.1.2 uses a function-by-function analysis of the Cochlear Implant Fitting 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 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: AutoHUD Heads-Up Display Controller | Automotive HUD Controller Firmware | Class A
Rendering critical driving information on a windshield heads-up display. Firmware rendering vehicle speed, navigation, and ADAS warnings on a windshield-projected heads-up display.

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

[Assistant]
Description: The AutoHUD Heads-Up Display Controller shall require authentication before allowing modification of device configuration parameters via CAN bus.
Rationale: Access control prevents unauthorized modification of the Automotive HUD Controller 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 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):

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

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the InfuSafe Controller (insulin infusion pump controller, Class C). Standards references are accurate.


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

[User]
Expand requirement SRS-PERF-001: "measurement accuracy specification" (Category: performance)
Project: PathCloud AI Histology Analyzer | Cloud SaMD Histopathology Analysis Platform | Class B
AI-assisted identification of suspicious regions in digitized histology slides for pathologist review. Cloud-hosted SaMD analyzing whole-slide histology images with deep learning to flag suspicious regions for pathologist review. Runs as a multi-tenant SaaS.

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

[Assistant]
Description: The PathCloud AI Histology Analyzer shall maintain measurement accuracy within the specified tolerance across the full operating range of the primary sensor.
Rationale: Inaccurate output from the Cloud SaMD Histopathology Analysis Platform could lead to incorrect clinical actions, making accuracy a safety-critical requirement.
Priority: Mandatory
Acceptance Criterion: Accuracy verified against a calibrated reference across the full measurement range, with all readings within tolerance for 200+ test points.
Source: Regulatory


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

[User]
Write a FMEA section on risk control verification for TrainCert Staff Certification Tracker, a Class A Training Certification System. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Web app tracking staff training certifications and renewal dates. Administrative HR tool for compliance tracking.

[Assistant] Content: Risk control verification for the TrainCert Staff Certification Tracker per Clause 7.3.1 confirms that each control is correctly implemented and effective. Test cases exercise the control under normal and boundary conditions. Verification evidence per Clause 7.3.3 links the test result to the risk control measure and the originating hazard in the Training Certification System risk management file.


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

[User]
Expand requirement SRS-FUNC-003: "data logging and retrieval" (Category: functional)
Project: AutoclaveLog Cycle Recorder | Sterilization Cycle Data Logger | Class A
Recording and reporting autoclave sterilization cycle parameters. PC software recording autoclave cycle data (time, temperature, pressure) and generating compliance reports.

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

[Assistant]
Description: All processed measurements shall be stored with timestamps in a persistent log accessible through RS-232 serial for clinical review and regulatory audit.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Sterilization Cycle Data Logger.
Priority: Desirable
Acceptance Criterion: Data retrieval produces complete, uncorrupted records for the full specified retention period.
Source: User need


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

[User]
Expand requirement SRS-INTF-002: "clinical system integration interface" (Category: interface)
Project: HydroRemind Hydration Tracker | Hydration Tracking Firmware | Class A
Passive display of daily water consumption for wellness. Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

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

[Assistant]
Description: Data interoperability with clinical information systems shall be provided through BLE 5.0, supporting standard message formats.
Rationale: Interoperability enables integration of Hydration Tracking Firmware data into the clinical workflow and patient record.
Priority: Desirable
Acceptance Criterion: Format validation passes for all message types with correct field encoding verified.
Source: User need


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

[User]
Expand requirement SRS-PERF-001: "resource utilization limits" (Category: performance)
Project: AutoPancreas Closed-Loop Glucose Controller | Artificial Pancreas Controller Firmware | Class C
Automated closed-loop insulin delivery based on continuous glucose monitoring with predictive algorithms. Artificial pancreas firmware integrating CGM readings with insulin pump delivery using a PID control algorithm. Life-sustaining closed-loop system.

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 AutoPancreas Closed-Loop Glucose Controller memory footprint on nRF5340 (dual-core) shall remain within specified limits under worst-case operational scenarios.
Rationale: Exceeding memory limits could cause undefined behavior in the Artificial Pancreas Controller Firmware, potentially affecting safety.
Priority: Mandatory
Acceptance Criterion: Memory profiling under stress conditions shows stable allocation with no leaks over a 72-hour test period.
Source: System requirement


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

[User]
Write a SDP section on tool qualification for Class B and C for PainRelief PCA Pump Controller, a Class C PCA Pump Controller Firmware. Reference IEC 62304 Clause 5.1.4.
Patient-controlled analgesia pump firmware allowing patient-initiated doses within physician-set limits. Overdose prevention is safety-critical.

[Assistant] Content: Tools used in verification of the PainRelief PCA Pump Controller undergo qualification per IEC 62304 Clause 5.1.4. This includes the C (embedded, MISRA C) compiler, static analysis tools, and test execution frameworks. Qualification evidence demonstrates that each tool produces correct and repeatable results for the verification activities it supports.


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

[User]
Write a SDP section on development platform and build infrastructure for LabStream LIS Middleware, a Class A Laboratory Information Middleware. Reference IEC 62304 Clause 5.1.4.
Middleware software connecting laboratory analyzers to the hospital LIS. Routes results, applies auto-validation rules, and flags critical values.

[Assistant] Content: Source code for the LabStream LIS Middleware Laboratory Information Middleware is written in Java (Spring Boot) and compiled for Linux server (Docker). The build pipeline is automated and deterministic -- identical source revisions produce identical binaries. All build tool versions are captured in the configuration baseline per Clause 5.1.4.


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

[User]
Expand requirement SRS-DATA-001: "data integrity validation" (Category: data)
Project: SleepScore Apnea Screening Tool | Sleep Apnea Screening App | Class B
Screening for sleep apnea indicators using smartphone audio analysis, requiring sleep study confirmation. Mobile app analyzing overnight audio recordings to screen for obstructive sleep apnea indicators. Screening only, not diagnostic.

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

[Assistant]
Description: The SleepScore Apnea Screening Tool shall validate the integrity of stored data using checksums, detecting and reporting any corruption of measurement records.
Rationale: Corrupted data must be identified to prevent clinical decisions based on unreliable measurements.
Priority: Mandatory
Acceptance Criterion: Intentionally corrupted records are detected and flagged with 100% detection rate across 100 injected corruption events.
Source: System requirement


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

[User]
Write a SDP section on safety classification process and documentation for AllergyCard Patient Allergy Viewer, a Class A Patient Allergy Display. Reference IEC 62304 Clause 4.3.
Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

[Assistant] Content: The AllergyCard Patient Allergy Viewer safety classification is a prerequisite for determining the scope of IEC 62304 lifecycle activities. The classification was performed per Clause 4.3 using hazard analysis inputs from the ISO 14971 risk management process. Changes to the Patient Allergy Display intended use or risk profile trigger reclassification.


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

[User]
Expand requirement SRS-FUNC-002: "guard position switches data capture and buffering" (Category: functional)
Project: ConveyorGuard Safety Interlock System | Conveyor Safety Interlock Software | Class A
Monitoring safety interlocks and emergency stops on industrial conveyor systems. Safety PLC program monitoring conveyor belt guard positions, emergency stops, and light curtains. Functional safety application.

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 ConveyorGuard Safety Interlock System software shall acquire guard position switches data at the specified sampling rate and store values in a circular buffer for processing by the Conveyor Safety Interlock Software signal pipeline.
Rationale: Continuous data acquisition from the primary sensor is the fundamental input for Monitoring safety interlocks and emergency stops on industrial conveyor systems.
Priority: Mandatory
Acceptance Criterion: System test confirms zero missed samples over a 24-hour continuous operation period at the maximum configured sampling rate.
Source: System requirement


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

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

"In accordance with IEC 62304-4, verification activities include system testing."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304-4" which is incorrect. IEC 62304 has no Part 4. 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 SOUP identification and management for DermaAssist Skin Lesion Classifier, a Class B Skin Lesion Classification App. Reference IEC 62304 Clause 8.1.2.
Mobile app using a CNN to classify skin lesion images as benign/suspicious. Decision support requiring dermatologist confirmation.

[Assistant] Content: SOUP components in the DermaAssist Skin Lesion Classifier are catalogued per Clause 8.1.2 with title, version, supplier, and license terms. The risk management process evaluates each SOUP item's known anomaly list per Clause 7.1.3 to determine whether any published defect could contribute to a hazardous situation in the Skin Lesion Classification App.


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

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

"The RadBeam Planner architecture is defined. The RadBeam Planner architecture is documented. The RadBeam Planner architecture is verified. The RadBeam Planner architecture is reviewed. The RadBeam Planner architecture is approved."

[Assistant]
Verdict: FAIL
Note: The documentation section exhibits repeated project name. The project name 'RadBeam Planner' appears excessively. Sentences repeat the same assertion about the radiation therapy planning system in different words. Content should be consolidated and each sentence should contribute unique, specific information about the RadBeam Planner.


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

[User]
Write a SRS section on operational context and user population for WeatherNode Microclimate Station, a Class A Weather Station Firmware. Reference IEC 62304 Clause 5.2.2.
Solar-powered weather station firmware measuring temperature, humidity, wind, rainfall, and barometric pressure.

[Assistant] Content: This section describes the operational context of the WeatherNode Microclimate Station Weather Station Firmware. The system is intended for Automated measurement and transmission of microclimate weather parameters, operating on STM32WL (LoRa SoC). Key interfaces include LoRaWAN, solar MPPT, flash storage. These contextual factors drive the functional and non-functional requirements specified in subsequent sections.


[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 external system communication requirements for SterilLog Sterilization Record System, a Class A Sterilization Record Logger. Reference IEC 62304 Clause 5.2.2.
Software logging sterilization cycle parameters from autoclaves. Records temperature, pressure, and time for compliance documentation.

[Assistant] Content: The SterilLog Sterilization Record System communicates with external systems via database. Requirements specify authentication, data encryption, message integrity verification, and timeout handling. The Sterilization Record Logger must continue safe operation if the external system is unavailable.


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

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

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

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


[System] You are a 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 DermaLens Teledermatology Platform, a Class B Cloud Teledermatology SaMD. Reference IEC 62304 Clauses 9.4, 9.6.
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: Problem resolution for the DermaLens Teledermatology Platform integrates with change control per Clause 9.4 -- every correction is implemented as a controlled change with impact assessment and regression testing. Trends per Clause 9.6 are evaluated quarterly and at release readiness to identify systemic quality issues in the Cloud Teledermatology SaMD.


[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):

"The RadView DICOM lifecycle follows an industry-standard methodology ensuring compliance with applicable regulations. Phase gates are established at appropriate milestones."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "industry-standard", "appropriate milestones" provide no project-specific information about the RadView DICOM DICOM image viewer. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

[User]
Expand requirement SRS-FUNC-006: "audit trail and data export" (Category: functional)
Project: InfuRate IV Flow Calculator | Infusion Rate Calculator | Class B
Calculating IV infusion rates from prescribed doses, concentrations, and patient parameters. Desktop calculator for IV infusion rates based on drug concentration, patient weight, and ordered dose. Clinical decision support tool.

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 Infusion Rate Calculator shall maintain a timestamped record of all measurements in non-volatile storage, supporting export via desktop GUI.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Infusion Rate Calculator.
Priority: Desirable
Acceptance Criterion: Logged data is retrievable after power cycle, with all timestamps accurate to within 1 second of the reference clock.
Source: User need


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

[User]
Write a SRS section on system boundaries and external dependencies for SleepScore Apnea Screening Tool, a Class B Sleep Apnea Screening App. Reference IEC 62304 Clause 5.2.2.
Mobile app analyzing overnight audio recordings to screen for obstructive sleep apnea indicators. Screening only, not diagnostic.

[Assistant] Content: External dependencies of the SleepScore Apnea Screening Tool include the iOS + cloud operating environment, smartphone microphone, and audio API. The Sleep Apnea Screening App requirements assume these dependencies operate within their specified parameters; failure modes of external components are addressed in the risk analysis.


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

[User]
Write a TRACE section on traceability scope including risk controls for AIDose Chemotherapy Decision Support, a Class C Cloud AI Chemotherapy Dosing SaMD. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Cloud SaMD providing AI-driven chemotherapy dosing recommendations based on patient genomics, lab values, and treatment response data.

[Assistant] Content: The AIDose Chemotherapy Decision Support traceability matrix extends beyond functional requirements to include risk control traceability per Clause 7.3.2. Each risk control measure implemented in the Cloud AI Chemotherapy Dosing SaMD software is traced from the ISO 14971 hazard through the software requirement to the verification test confirming its effectiveness.


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

[User]
Write a SRS section on data format and interoperability requirements for CogniTest Cognitive Assessment App, a Class B Cognitive Assessment Application. Reference IEC 62304 Clause 5.2.2.
Tablet app administering standardized cognitive screening tests and scoring results. Used by neuropsychologists in clinical settings.

[Assistant] Content: Data exchanged by the CogniTest Cognitive Assessment App via local database conforms to defined formats documented in this SRS. The Cognitive Assessment Application validates incoming data against the format specification and rejects malformed messages with a logged error. Output data formats are deterministic and reproducible.


[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 change control and trend analysis for problems for DoseVerify In-Vivo Dosimetry System, a Class C In-Vivo Dosimetry Verification Software. Reference IEC 62304 Clauses 9.4, 9.6.
Software calculating real-time delivered dose from in-vivo dosimeter readings during radiation therapy. Dose verification for patient safety.

[Assistant] Content: Problem resolution for the DoseVerify In-Vivo Dosimetry System integrates with change control per Clause 9.4 -- every correction is implemented as a controlled change with impact assessment and regression testing. Trends per Clause 9.6 are evaluated quarterly and at release readiness to identify systemic quality issues in the In-Vivo Dosimetry Verification Software.


[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):

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

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


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

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

[Assistant] Content: The TriageAI Emergency Triage Assistant performance requirements define measurable bounds on processing latency, data throughput, and memory utilization. The ED Triage Decision Support App must sustain these performance levels under peak operating conditions on iPad web app throughout the full duration of Assisting emergency nurses with triage acuity scoring based on patient assessment data.


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

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

"The development plan references IEC 62304 Clause 5.5.6 and Clause 7.5 for the RetinaScan Pro."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.5.6 and 7.5, neither of which exists. Clause 5.5 has 5.5.1 through 5.5.5 only. Clause 7 ends at 7.4. All clause references must be corrected.


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

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

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

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


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

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

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

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


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

[User]
Write a SRS section on data format and interoperability requirements for TransVent Transport Ventilator, a Class C Transport Ventilator Firmware. Reference IEC 62304 Clause 5.2.2.
Portable transport ventilator firmware for ambulance and helicopter use. Must maintain ventilation under vibration and altitude changes.

[Assistant] Content: Data exchanged by the TransVent Transport Ventilator via blower driver conforms to defined formats documented in this SRS. The Transport Ventilator Firmware validates incoming data against the format specification and rejects malformed messages with a logged error. Output data formats are deterministic and reproducible.


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

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

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

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


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

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

"The CaloriePal software architecture is decomposed into units with detailed design specifications. Integration testing validates data flow between all units. Independent verification of all test results is mandatory."

[Assistant]
Verdict: FAIL
Note: Content mandates detailed design, integration testing, and independent verification for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Clauses 5.4, 5.6, and independent verification are not required for Class A.


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

[User]
Write a SAD section on SOUP component integration and requirements for DermaAssist Skin Lesion Classifier, a Class B Skin Lesion Classification App. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Mobile app using a CNN to classify skin lesion images as benign/suspicious. Decision support requiring dermatologist confirmation.

[Assistant] Content: SOUP integration in the DermaAssist Skin Lesion Classifier architecture follows Clause 5.3.3 and Clause 5.3.4. Each SOUP item has documented functional requirements, performance requirements, and platform dependencies. The Skin Lesion Classification App architecture ensures SOUP components are isolated behind defined interfaces to limit the impact of SOUP defects.


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

[User]
Write a SAD section on SOUP component integration and requirements for GlucoSpot Continuous Glucose Display, a Class B CGM Display App. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Mobile app receiving and displaying continuous glucose monitor readings via BLE. Shows trends, time-in-range, and configurable glucose alerts.

[Assistant] Content: SOUP components in the GlucoSpot Continuous Glucose Display are integrated through defined interfaces per Clause 5.3.3. For each component, the architecture specifies the functions used, the performance expectations, and the iOS/Android requirements per Clause 5.3.4. SOUP anomaly evaluation per Clause 7.1.3 is documented in the risk management file.


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

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

"The PillRemind development environment is configured following best practices. Tools are selected as appropriate for the project requirements."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as appropriate", "best practices" provide no project-specific information about the PillRemind medication reminder 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-INTF-001: "primary sensor interface protocol" (Category: interface)
Project: CleanRoom Particle Counter Logger | Cleanroom Environmental Logger | Class A
Logging and displaying airborne particle counts for cleanroom compliance. Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

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

[Assistant]
Description: The Cleanroom Environmental Logger sensor interface shall establish and maintain reliable communication with the optical particle counter via RS-485 Modbus.
Rationale: Reliable sensor communication is the foundation of the Cleanroom Environmental Logger 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 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 InsuPrecise Insulin Pump Controller, a Class C Insulin Pump Controller Firmware. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Embedded firmware controlling insulin delivery in a patch-type insulin pump. Incorrect dosing could cause severe hypoglycemia or diabetic ketoacidosis.

[Assistant] Content: Risk control measures for the InsuPrecise Insulin Pump Controller are defined per Clause 7.2.1 and implemented in software per Clause 7.2.2. Controls include input validation for micro-flow sensor, range checking on processed values, and timeout detection on BLE 5.0 to companion app. Each control is traced to a software requirement and verified through testing.


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

[User]
Expand requirement SRS-PERF-002: "resource utilization limits" (Category: performance)
Project: AquaGuard Water Quality Monitor | Water Quality Monitoring Firmware | Class A
In-situ measurement of water quality parameters for environmental monitoring. Firmware for a multi-parameter water quality probe measuring pH, dissolved oxygen, conductivity, and turbidity in rivers and lakes.

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 AquaGuard Water Quality Monitor shall operate within the specified RAM and flash memory budget on the MSP430FR (ultra-low-power) platform, including all runtime allocations.
Rationale: Exceeding memory limits could cause undefined behavior in the Water Quality Monitoring Firmware, potentially affecting safety.
Priority: Mandatory
Acceptance Criterion: Peak RAM usage during worst-case scenario does not exceed the specified limit, with minimum margin remaining.
Source: System requirement


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

[User]
Write a SDP section on SOUP identification and management for ClinTrial EDC Platform, a Class A Clinical Trial EDC Web Platform. Reference IEC 62304 Clause 8.1.2.
Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

[Assistant] Content: Identification of SOUP for the ClinTrial EDC Platform follows Clause 8.1.2. Each SOUP component record includes title, version, supplier, intended function within the Clinical Trial EDC Web Platform, and a reference to the anomaly evaluation performed per Clause 7.1.3. SOUP updates are managed through the change control process per Clause 8.2.


[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):

"Code coverage analysis is mandatory for the PillRemind with minimum 85% line coverage."

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


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

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

"Testing is performed at appropriate levels as determined by the project risk assessment. Test results are documented and reviewed by qualified personnel."

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


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

[User]
Write a THREAT section on STRIDE threat categories applied to the device for TeleRehab Remote Patient Monitor, a Class B Remote Rehabilitation Platform. Reference IEC 62304 Clause 5.2.2.
Platform enabling remote physiotherapy with video consultations and wearable sensor data streaming. Generates exercise adherence reports.

[Assistant] Content: Threats to the TeleRehab Remote Patient Monitor are categorized using the STRIDE framework: Spoofing of WebRTC identity, Tampering with sensor data or configuration, Repudiation of clinical actions, Information Disclosure of patient data, Denial of Service disrupting Remote physiotherapy monitoring with exercise tracking and therapist-patient video sessions, and Elevation of Privilege through unauthorized parameter changes.


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

[User]
Write a SDP section on purpose and scope for Class A with minimal documentation for AutoHUD Heads-Up Display Controller, a Class A Automotive HUD Controller Firmware. Reference IEC 62304 Clause 5.1.1.
Firmware rendering vehicle speed, navigation, and ADAS warnings on a windshield-projected heads-up display.

[Assistant] Content: The scope of this plan covers the full software lifecycle of the AutoHUD Heads-Up Display Controller, a Automotive HUD Controller Firmware classified as Safety Class A under IEC 62304 Clause 4.3. Because the software cannot contribute to a hazardous situation, the plan omits detailed design documentation (Clause 5.4), unit verification (Clause 5.5), and integration testing (Clause 5.6), concentrating instead on system-level activities that confirm the Automotive HUD Controller Firmware meets its specified requirements.


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

[User]
Write a SAD section on SOUP component integration and requirements for AnticoagCalc INR Dose Adjuster, a Class B Anticoagulation Dosing Support Tool. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Web tool suggesting warfarin dose adjustments based on INR readings and patient history. Clinical decision support requiring physician review.

[Assistant] Content: Third-party software components used in the AnticoagCalc INR Dose Adjuster are documented per Clause 5.3.3, including functional and performance requirements imposed on each SOUP item. Hardware and software dependencies per Clause 5.3.4 are recorded to ensure that the Web application environment satisfies all SOUP prerequisites.


[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):

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

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


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

[User]
Write a SDP section on tool qualification for Class B and C for HemaCount Digital Cell Counter, a Class B IVD Digital Cell Counter Software. Reference IEC 62304 Clause 5.1.4.
Desktop software performing automated differential white blood cell counting on digitized blood smear images using computer vision.

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


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

[User]
Expand requirement SRS-FUNC-004: "startup diagnostic verification" (Category: functional)
Project: StepSync Activity Tracker | Wellness Activity Display App | Class A
Passive display of physical activity metrics for personal wellness tracking. Mobile app displaying daily step count, distance, and calories from a wrist-worn accelerometer. Read-only display with no clinical interpretation.

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

[Assistant]
Description: Upon power-up, the StepSync Activity Tracker shall execute a self-test sequence verifying the integrity of the 3-axis accelerometer interface, internal memory, and output subsystem before entering operational mode.
Rationale: A power-on self-test confirms hardware and software readiness before the Wellness Activity Display App begins use.
Priority: Mandatory
Acceptance Criterion: Self-test completes within the specified startup time and correctly detects each of the following injected faults: sensor disconnection, memory corruption, and display failure.
Source: System requirement


[System] You are 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):

"The development plan references IEC 62304 Clause 4.4 and Clause 7.5 for the LabView Portal."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 4.4 and 7.5, neither of which exists. Clause 4 only has 4.1, 4.2, 4.3. Clause 7 ends at 7.4. All clause references must be corrected.


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

[User]
Write a SDP section on development tools and tool qualification for Class A for HumidityMap Room Condition Logger, a Class A Environmental Condition Logger. Reference IEC 62304 Clause 5.1.4.
Network of IoT sensors logging temperature and humidity across hospital storage areas. Dashboard display for facility management.

[Assistant] Content: Development of the HumidityMap Room Condition Logger uses C (embedded) + Python (backend) on ESP32 + cloud. Build automation ensures reproducible compilation, and all toolchain versions are recorded as part of the configuration management baseline. Given the Class A classification, no formal tool qualification report is produced; tool defects are handled through the standard problem resolution process.


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

[User]
Write a SDP section on requirements verification approach for BrachyDose HDR Afterloader Controller, a Class C HDR Brachytherapy Afterloader Firmware. Reference IEC 62304 Clause 5.2.6.
Firmware controlling high-dose-rate brachytherapy source positioning and dwell times. Source positioning errors cause lethal local radiation.

[Assistant] Content: Requirements verification for the BrachyDose HDR Afterloader Controller is conducted per Clause 5.2.6 before the requirements baseline is established. The review confirms completeness, consistency, and testability. Any requirement failing these criteria is returned for rework before the HDR Brachytherapy Afterloader Firmware proceeds to design.


[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 RenalDose Renal Adjustment Calculator, a Class B Renal Dose Adjustment Calculator. Reference IEC 62304 Clause 5.3.2.
Calculator adjusting medication doses for patients with impaired renal function based on eGFR.

[Assistant] Content: The RenalDose Renal Adjustment Calculator Renal Dose Adjustment Calculator software item interfaces per Clause 5.3.2 are defined using typed data structures with explicit ownership semantics. Each interface specifies the pre-conditions, post-conditions, and error conditions. Interface compatibility is verified through integration testing per Clause 5.6.


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

[User]
Write a SDP section on requirements elicitation and documentation for WeightAlert Neonatal Scale, a Class B Neonatal Scale Firmware. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

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


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

[User]
Write a FMEA section on risk control verification for BreathEasy Air Quality Display, a Class A Environmental Air Quality Display. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Indoor air quality monitor displaying PM2.5, CO2, and temperature on an LCD. Informational display only with no clinical guidance.

[Assistant] Content: Verification of risk control measures for the BreathEasy Air Quality Display follows Clause 7.3.1. Each software-implemented control is tested to demonstrate that the hazardous condition is mitigated to an acceptable level. Verification results per Clause 7.3.3 are documented in the risk management file for the Environmental Air Quality Display.


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

[User]
Write a SRS section on data processing and transformation requirements for HeartView Resting HR Display, a Class A Heart Rate Display Firmware. Reference IEC 62304 Clause 5.2.2.
Wearable firmware that shows resting heart rate on a small OLED screen. Read-only display with no arrhythmia detection or clinical alerts.

[Assistant] Content: The HeartView Resting HR Display data pipeline requirements specify end-to-end data flow from MAX30102 PPG sensor through processing to output on I2C. Requirements include input validation, range checking, unit conversion, and output formatting for Passive display of resting heart rate for wellness monitoring.


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

[User]
Expand requirement SRS-PERF-001: "end-to-end processing latency" (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: End-to-end latency from miniature camera data acquisition to output presentation shall not exceed the specified limit under normal operating conditions.
Rationale: Real-time performance is critical for the Retinal Prosthesis Controller Firmware to support timely clinical decisions based on current data.
Priority: Mandatory
Acceptance Criterion: End-to-end latency is within the specified limit for 99.9% of samples over a 24-hour test period.
Source: System requirement


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

[User]
Write a SDP section on requirements verification approach for FallRisk Inpatient Assessment Tool, a Class B Fall Risk Assessment App. Reference IEC 62304 Clause 5.2.6.
Web app calculating fall risk scores for inpatients based on mobility, medication, and cognitive assessments.

[Assistant] Content: Verification of FallRisk Inpatient Assessment Tool software requirements follows Clause 5.2.6. Reviewers confirm that every requirement is complete, consistent, testable, and traceable. Requirements that implement risk controls are additionally verified against the ISO 14971 risk management file for the Fall Risk Assessment App.


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

[User]
Write a SRS section on system boundaries and external dependencies for PostureGuard Desk Monitor, a Class A Posture Wellness Display Software. Reference IEC 62304 Clause 5.2.2.
USB webcam software that estimates sitting posture and displays a wellness score. No ergonomic prescriptions or clinical assessments.

[Assistant] Content: The PostureGuard Desk Monitor system overview identifies all external entities interacting with the Posture Wellness Display Software: input sources (USB webcam), output destinations (Desktop GUI), and the Windows/macOS desktop execution environment. Requirements for each external interface are documented in the interface requirements section.


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

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

"SOUP management for the EchoAssist 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 EchoAssist (echocardiogram analysis aid, Class B). 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 RadView DICOM (DICOM image viewer, Class A):

"Code coverage analysis is mandatory for the RadView DICOM with minimum 85% line coverage."

[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-FUNC-006: "configuration persistence and validation" (Category: functional)
Project: PharmaSafe CDSS | Clinical Decision Support System | Class B
Real-time clinical decision support for medication safety including interaction checking and dose validation. Clinical decision support system integrated into hospital EMR providing real-time drug-drug interaction alerts, allergy checking, and dosing guidance.

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 PharmaSafe CDSS shall allow authorized users to configure operating parameters via HL7 FHIR R4 hooks and persist settings across power cycles.
Rationale: Configurable parameters allow the Clinical Decision Support System to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: Configuration round-trip test: set, power-cycle, read-back for all parameters with 100% accuracy.
Source: User need


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

[User]
Write a SDP section on Class B classification justification and implications for TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clause 4.3.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

[Assistant] Content: Safety classification analysis per Clause 4.3 determined that the TriageAI Emergency Triage Assistant is Class B. The ED Triage Decision Support App can contribute to a hazardous situation during Assisting emergency nurses with triage acuity scoring based on patient assessment data, but the hazard severity is limited to non-serious injury due to mitigating controls in the clinical environment. Architectural documentation and integration testing are mandated at this classification level.


[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):

"The PillRemind 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.