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

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

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

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


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

[User]
Write a SDP section on Class B classification justification and implications for TeleRehab Remote Patient Monitor, a Class B Remote Rehabilitation Platform. Reference IEC 62304 Clause 4.3.
Platform enabling remote physiotherapy with video consultations and wearable sensor data streaming. Generates exercise adherence reports.

[Assistant] Content: The TeleRehab Remote Patient Monitor Remote Rehabilitation Platform is classified as Safety Class B under IEC 62304 Clause 4.3. Software malfunction could contribute to a hazardous situation, but independent risk controls external to the software prevent escalation to serious injury or death. The Class B designation requires architectural design verification (Clause 5.3.6), integration testing (Clause 5.6), and system testing (Clause 5.7).


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

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

"The AutoDose TPN conforms to IEC 62304:2006+AMD1:2015. Safety classification per Clause 4.3 designates this total parenteral nutrition calculator as Class C. Risk management follows ISO 14971:2019 with guidance from ISO/TR 24971:2020."

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


[System] You are 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 5.3.7 and Clause 10.1 for the LabView Portal."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.3.7 and 10.1, neither of which exists. Clause 5.3 has 5.3.1 through 5.3.6 only. IEC 62304 has no Clause 10. Standard ends at Clause 9. All clause references must be corrected.


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

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

"Maintenance activities follow IEC 62304-1 Clause 6."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304-1" which is incorrect. IEC 62304 is a single-part standard. The correct citation is IEC 62304:2006+AMD1:2015. All references must be corrected.


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

[User]
Expand requirement SRS-FUNC-005: "output refresh interval for VisitorPass Access Management" (Category: functional)
Project: VisitorPass Access Management | Visitor Management System | Class A
Visitor registration and temporary badge issuance for hospital access. Kiosk application for visitor registration and badge printing in hospital lobbies. Administrative access control.

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 VisitorPass Access Management shall update the displayed values on the USB at intervals no greater than the specified refresh period.
Rationale: Timely display updates ensure the user observes current readings without perceiving lag.
Priority: Mandatory
Acceptance Criterion: End-to-end latency from data acquisition to display update does not exceed the specified limit for 99.9% of samples.
Source: User need


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

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

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

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


[System] You are an IEC 62304 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 NeoVent Neonatal Ventilator, a Class C Neonatal Ventilator Firmware. Reference IEC 62304 Clauses 9.4, 9.6.
Neonatal ventilator firmware supporting CPAP, NIPPV, and conventional ventilation for extremely premature infants. Tidal volumes as low as 2 mL.

[Assistant] Content: Corrections to the NeoVent Neonatal Ventilator follow the change control process per Clause 9.4, with regression testing proportional to the scope of the change. Problem reports are periodically analyzed for trends per Clause 9.6 to identify systemic issues in the development process that might affect the quality of the Neonatal Ventilator Firmware.


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

[User]
Write a SRS section on data retention and integrity requirements for BreathEasy Air Quality Display, a Class A Environmental Air Quality Display. Reference IEC 62304 Clause 5.2.2.
Indoor air quality monitor displaying PM2.5, CO2, and temperature on an LCD. Informational display only with no clinical guidance.

[Assistant] Content: Persistent data managed by the BreathEasy Air Quality Display includes configuration parameters, acquired measurements from SCD41 CO2 sensor, and operational logs. Data integrity requirements specify error detection mechanisms and the Environmental Air Quality Display response to data corruption events.


[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):

"Compliance with IEC 62304 Clause 5.5.6 is demonstrated through automated regression testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.5.6 which does not exist. Clause 5.5 has 5.5.1 through 5.5.5 only. The reference must be corrected to a valid clause number.


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

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

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

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the OxyPure Controller (oxygen concentrator controller, 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 DialysisGuard (hemodialysis machine controller, Class C):

"Software safety classification is performed per IEC 62304-4 Clause 4.3."

[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 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 CardioPulse Monitor (cardiac rhythm monitor, Class B):

"The CardioPulse Monitor 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 CardioPulse Monitor (cardiac rhythm monitor, Class B). Standards references are accurate.


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

[User]
Write a SDP section on SOUP identification and management for RadOnco Cloud Treatment Planner, a Class C Cloud Radiation Treatment Planning SaMD. Reference IEC 62304 Clause 8.1.2.
Cloud-based radiation oncology treatment planning system using GPU clusters for Monte Carlo dose calculation. Treatment plans directly drive linear accelerator delivery.

[Assistant] Content: SOUP components in the RadOnco Cloud Treatment Planner 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 Cloud Radiation Treatment Planning SaMD.


[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 PaceSet Pacemaker Programmer, a Class C Cardiac Pacemaker Programmer Software. Reference IEC 62304 Clause 4.3.
Desktop software for interrogating and programming cardiac pacemakers via telemetry wand. Incorrect programming could cause pacing failure.

[Assistant] Content: Software safety classification for the PaceSet Pacemaker Programmer follows the procedure defined in IEC 62304 Clause 4.3. The classification considers whether the Cardiac Pacemaker Programmer Software can contribute to a hazardous situation and, if so, whether external risk controls reduce the severity to non-serious injury. The result directly determines which IEC 62304 lifecycle activities are mandatory.


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

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

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

[Assistant]
Description: Processing latency of the Air Quality Monitoring Station Firmware shall be bounded to ensure timely output that reflects current input conditions.
Rationale: Bounded processing latency ensures the Air Quality Monitoring Station Firmware provides readings reflecting the current state without clinically significant delay.
Priority: Mandatory
Acceptance Criterion: End-to-end latency is within the specified limit for 99.9% of samples over a 24-hour test period.
Source: System requirement


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

[User]
Write a SAD section on error propagation and data integrity in the pipeline for StrokeAlert CT Perfusion Analyzer, a Class C AI Stroke Triage CT Perfusion SaMD. Reference IEC 62304 Clause 5.3.2.
Time-critical cloud SaMD processing CT perfusion scans to generate ischemic core and penumbra maps for acute stroke triage. Results pushed to mobile app within 5 minutes.

[Assistant] Content: The StrokeAlert CT Perfusion Analyzer architecture prevents error propagation by requiring input validation at every software item boundary per Clause 5.3.2. When a software item detects invalid input, it transitions to a defined error state and notifies the error management subsystem. The AI Stroke Triage CT Perfusion SaMD maintains safe operation during error recovery.


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

[User]
Write a SDP section on safety classification process and documentation for BillingBridge Claims Processor, a Class A Claims Processing Service. Reference IEC 62304 Clause 4.3.
Backend service processing insurance claims from the hospital billing system. Financial processing only, no clinical data.

[Assistant] Content: The safety classification of the BillingBridge Claims Processor was determined per IEC 62304 Clause 4.3, considering the software's contribution to hazardous situations identified in the ISO 14971 risk analysis. The classification is documented in the risk management file and reviewed whenever the intended use, system architecture, or risk profile of the Claims Processing Service changes.


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

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

"Software release for the RadBeam Planner 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 RadBeam Planner (radiation therapy planning system, Class C). 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 BloodBank Manager (blood bank inventory system, Class A):

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

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


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

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

"The maintenance plan ensures continued compliance with applicable requirements. Updates are managed through established change control as appropriate."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as appropriate", "applicable requirements" provide no project-specific information about the GlucoTrack CGM continuous glucose monitor display. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

[User]
Write a SRS section on data format and interoperability requirements for IncidentReport Clinical Event Logger, a Class A Incident Reporting System. Reference IEC 62304 Clause 5.2.2.
Web form for staff to submit clinical incident reports. Data entry and routing only, no analysis.

[Assistant] Content: Data exchanged by the IncidentReport Clinical Event Logger via REST API conforms to defined formats documented in this SRS. The Incident Reporting System 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 CaloriePal (nutrition tracking app, Class A):

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

[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. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a TRACE section on risk control coverage verification for BillingBridge Claims Processor, a Class A Claims Processing Service. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Backend service processing insurance claims from the hospital billing system. Financial processing only, no clinical data.

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


[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):

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

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


[System] You are 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 InfuRate IV Flow Calculator, a Class B Infusion Rate Calculator. Reference IEC 62304 Clause 5.2.6.
Desktop calculator for IV infusion rates based on drug concentration, patient weight, and ordered dose. Clinical decision support tool.

[Assistant] Content: Software requirements are verified per Clause 5.2.6 through formal review confirming each requirement is unambiguous, testable, consistent with system requirements, and traceable to its source. The InfuRate IV Flow Calculator requirements baseline is frozen only after successful review by the designated reviewers.


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

[User]
Expand requirement SRS-FUNC-002: "measurement data archival" (Category: functional)
Project: WoundTrack Healing Analyzer | Wound Assessment App | Class B
Photographic wound measurement and healing progress tracking for clinical review. Mobile app photographing wounds and measuring area/perimeter over time to track healing progress for clinician review.

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

[Assistant]
Description: The Wound Assessment App shall maintain a timestamped record of all measurements in non-volatile storage, supporting export via camera 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 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 release criteria for the NeuroStim Programmer include completeness of all Class C deliverables (Clause 5.8.1), correct version identification (Clause 5.8.2), documented residual anomalies (Clause 5.8.4), and release approval by the quality representative."

[Assistant]
Verdict: PASS
Note: Content correctly specifies full Class C rigor. Standards references are accurate.


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

[User]
Write a FMEA section on failure mode identification approach for SupplyChain Procurement Portal, a Class A Supply Chain Procurement System. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Web portal for ordering medical supplies with approval workflows. Procurement and logistics only.

[Assistant] Content: Software failure modes in the SupplyChain Procurement Portal are identified using a structured approach per Clause 7.1.2: each software item is analyzed for what could go wrong (the failure mode), why it could go wrong (the cause), and what would happen (the effect). SOUP component anomalies per Clause 7.1.3 are included as potential failure causes.


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

[User]
Write a SAD section on architecture verification scope for PainRelief PCA Pump Controller, a Class C PCA Pump Controller Firmware. Reference IEC 62304 Clauses 5.3.1, 5.3.6.
Patient-controlled analgesia pump firmware allowing patient-initiated doses within physician-set limits. Overdose prevention is safety-critical.

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


[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: "power-on self-test sequence" (Category: functional)
Project: WeatherNode Microclimate Station | Weather Station Firmware | Class A
Automated measurement and transmission of microclimate weather parameters. Solar-powered weather station firmware measuring temperature, humidity, wind, rainfall, and barometric pressure.

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

[Assistant]
Description: A power-on self-test shall validate BME280 communication, memory integrity, and LoRaWAN connectivity before the Weather Station Firmware transitions to its operational state.
Rationale: Startup verification prevents the Weather Station Firmware from operating with undetected faults that could affect output accuracy.
Priority: Mandatory
Acceptance Criterion: All fault injection scenarios are detected with 100% reliability across 50 test iterations.
Source: System requirement


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

[User]
Write a SAD section on SOUP component integration and requirements for LabStream LIS Middleware, a Class A Laboratory Information Middleware. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Middleware software connecting laboratory analyzers to the hospital LIS. Routes results, applies auto-validation rules, and flags critical values.

[Assistant] Content: Third-party software components used in the LabStream LIS Middleware 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 Linux server (Docker) 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):

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

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


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

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

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

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


[System] You are 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 elicitation and documentation for AirSentry Urban Air Quality Station, a Class A Air Quality Monitoring Station Firmware. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
IoT firmware for urban air quality monitoring stations measuring PM2.5, NO2, O3, and CO. Publishes data to public API.

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

[User]
Write a SRS section on user interaction requirements for NeoVent Neonatal Ventilator, a Class C Neonatal Ventilator Firmware. Reference IEC 62304 Clause 5.2.2.
Neonatal ventilator firmware supporting CPAP, NIPPV, and conventional ventilation for extremely premature infants. Tidal volumes as low as 2 mL.

[Assistant] Content: The NeoVent Neonatal Ventilator user interaction requirements define the observable behavior of the Neonatal Ventilator Firmware from the user's perspective. Requirements are organized by use scenario and specify the information displayed, the timing of updates, and the user actions supported during Mechanical ventilatory support for neonatal patients with precise low-volume delivery.


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

[User]
Write a SRS section on resource constraints and scalability for 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: Computational resource requirements for the TransVent Transport Ventilator define the maximum CPU utilization, RAM consumption, and flash/disk usage permitted on STM32H7. The Transport Ventilator Firmware must meet all functional and timing requirements within these resource envelopes.


[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: "computational accuracy requirement" (Category: performance)
Project: DoseVerify In-Vivo Dosimetry System | In-Vivo Dosimetry Verification Software | Class C
Real-time verification of delivered radiation dose using in-vivo dosimeter measurements during treatment. Software calculating real-time delivered dose from in-vivo dosimeter readings during radiation therapy. Dose verification for patient safety.

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

[Assistant]
Description: Output accuracy of the In-Vivo Dosimetry Verification Software shall meet or exceed the specified tolerance for all measurement parameters across operating conditions.
Rationale: Measurement accuracy directly affects clinical decisions based on the In-Vivo Dosimetry Verification Software output and is a key factor in the risk profile.
Priority: Mandatory
Acceptance Criterion: Accuracy verified against a calibrated reference across the full measurement range, with all readings within tolerance for 200+ test points.
Source: Regulatory


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

[User]
Write a SDP section on internal SOPs and procedures for VitalPulse SpO2 Monitor, a Class B Pulse Oximeter Firmware. Reference IEC 62304 Clause 5.1.2.
Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

[Assistant] Content: Company-internal standard operating procedures supplement the international standards for the VitalPulse SpO2 Monitor project. SOP-010 through SOP-013 address development planning, risk management, configuration management, and verification planning. All SOPs are part of the ISO 13485 quality management system and are binding on the Pulse Oximeter Firmware development team.


[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 RetinaScan Diabetic Retinopathy Screener, a Class B Retinal Screening Software. Reference IEC 62304 Clause 5.2.2.
Desktop software analyzing retinal fundus images to detect signs of diabetic retinopathy for ophthalmologist review.

[Assistant] Content: The RetinaScan Diabetic Retinopathy Screener data pipeline requirements specify end-to-end data flow from fundus camera DICOM input through processing to output on DICOM. Requirements include input validation, range checking, unit conversion, and output formatting for AI-assisted screening of retinal images for diabetic retinopathy signs, requiring specialist confirmation.


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

[User]
Write a SDP section on development methodology for Class A for SeismicWatch Earthquake Early Warning, a Class A Seismic Early Warning Firmware. Reference IEC 62304 Clause 5.1.1.
Firmware for a network of MEMS accelerometers providing earthquake early warning by detecting P-waves and estimating magnitude.

[Assistant] Content: A streamlined iterative model governs the SeismicWatch Earthquake Early Warning development. Given the Class A classification, the lifecycle omits formal architecture verification and detailed design phases, proceeding directly from requirements to implementation and then to system-level verification of the Seismic Early Warning Firmware on Zynq-7000 SoC (FPGA + ARM).


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

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

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

[Assistant]
Verdict: FAIL
Note: Content mandates MISRA C static analysis and MC/DC unit testing for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). MISRA C and MC/DC coverage targets are Class C considerations, not required for Class A.


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

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

[Assistant] Content: The TriageAI Emergency Triage Assistant architecture isolates external dependencies behind abstraction interfaces per Clause 5.3.2. The manual input and EMR integration via FHIR communication interfaces are accessed through adapter modules that translate protocol-specific details into the internal data model of the ED Triage Decision Support App.


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

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

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

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


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

[User]
Expand requirement SRS-FUNC-001: "device configuration management" (Category: functional)
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: Operating parameters of the Pulse Oximeter Firmware shall be user-configurable within validated ranges and stored in non-volatile memory.
Rationale: Configurable parameters allow the Pulse Oximeter Firmware to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: All configurable parameters persist correctly across power cycles and reject out-of-range values with appropriate error messages.
Source: User need


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

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

[Assistant] Content: The RemotICU Continuous Monitoring Hub resource constraints are derived from the Intel NUC edge gateway + AWS IoT Core + React SPA hardware capabilities. Requirements specify headroom margins for memory and processing to ensure the Edge-to-Cloud ICU Monitoring Gateway remains stable under sustained operation during Aggregating bedside monitor data at the edge and streaming to cloud for tele-ICU clinical oversight.


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

[User]
Write a SRS section on sensor and communication protocol requirements for HydroRemind Hydration Tracker, a Class A Hydration Tracking Firmware. Reference IEC 62304 Clause 5.2.2.
Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

[Assistant] Content: The HydroRemind Hydration Tracker interfaces with Hall-effect flow sensor via BLE 5.0. Interface requirements specify the physical layer, data format, sampling rate, and error handling for each connection. All interface requirements are verifiable through integration or system testing.


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

[User]
Expand requirement SRS-INTF-001: "sensor data link requirements" (Category: interface)
Project: DoseLog Radiation Badge Reader | Dosimetry Data Logger | Class A
Reading and archiving personal radiation exposure data from dosimeter badges. Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health 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 Dosimetry Data Logger sensor interface shall establish and maintain reliable communication with the dosimeter badge reader via USB.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Dosimetry Data Logger output.
Priority: Mandatory
Acceptance Criterion: Error injection tests confirm 100% detection rate for corrupted frames and recovery within specified timeout.
Source: System requirement


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

[User]
Expand requirement SRS-FUNC-002: "user-configurable operating parameters" (Category: functional)
Project: VibeCheck Vibration Analyzer | Vibration Analysis Instrument Firmware | Class A
Vibration spectrum analysis of industrial machinery for predictive maintenance. Portable vibration analysis firmware for predictive maintenance of industrial rotating machinery. FFT analysis of accelerometer data.

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

[Assistant]
Description: The VibeCheck Vibration Analyzer shall allow authorized users to configure operating parameters via BNC input and persist settings across power cycles.
Rationale: Configurable parameters allow the Vibration Analysis Instrument Firmware to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: All configurable parameters persist correctly across power cycles and reject out-of-range values with appropriate error messages.
Source: User need


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

[User]
Expand requirement SRS-PERF-001: "measurement accuracy specification" (Category: performance)
Project: NeuroTune DBS Programmer | Deep Brain Stimulator Programmer App | Class C
Programming stimulation parameters of implanted deep brain stimulators for Parkinson's disease management. Tablet application programming deep brain stimulation implants for movement disorders. Stimulation parameter errors could cause neurological harm.

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 NeuroTune DBS Programmer shall maintain measurement accuracy within the specified tolerance across the full operating range of the NFC/BLE telemetry.
Rationale: Inaccurate output from the Deep Brain Stimulator Programmer App could lead to incorrect clinical actions, making accuracy a safety-critical requirement.
Priority: Mandatory
Acceptance Criterion: Statistical analysis of 500 measurements shows mean error within tolerance and standard deviation within specified limits.
Source: Regulatory


[System] You are 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 DialysisGuard (hemodialysis machine controller, Class C):

"REQ-SRS-045: The DialysisGuard 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 requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-SAFE-001: "fail-safe behavior specification" (Category: safety)
Project: HemaCount Digital Cell Counter | IVD Digital Cell Counter Software | Class B
Automated white blood cell differential counting from digitized peripheral blood smear images. Desktop software performing automated differential white blood cell counting on digitized blood smear images using computer vision.

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 IVD Digital Cell Counter Software shall enter a defined safe state within the maximum allowable transition time when a critical fault is detected, ensuring no hazardous output persists.
Rationale: Fail-safe behavior is essential to prevent the IVD Digital Cell Counter Software from causing harm when its software detects an unrecoverable error.
Priority: Mandatory
Acceptance Criterion: Safe state transition completes within the specified time limit for each defined critical fault, verified by fault injection during operation.
Source: Risk control


[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):

"As Class A software, the ThermoGuard follows a streamlined verification approach. System tests are traced to software requirements and executed in the intended operating environment. Test records include pass/fail status, date, and tester identity per Clause 5.7.5. No code coverage metrics are mandated."

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


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

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

"Architectural design follows IEC 62304-3 Clause 5.3 for Class A devices."

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


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

[User]
Write a FMEA section on documenting failure modes and their effects for PedDose Pediatric Dosing App, a Class B Pediatric Dosing Calculator App. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Mobile reference app for pediatric drug dosing with weight-based calculations and age-specific ranges.

[Assistant] Content: Each identified failure mode of the PedDose Pediatric Dosing App is documented per Clause 7.1.4 with the failure mode description, potential causes, local effects, end effects on the Pediatric Dosing Calculator App, severity classification, and existing controls. The documentation supports risk control decision-making per Clause 7.2.1.


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

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

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

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as appropriate", "best practices", "applicable standards" provide no project-specific information about the RadBeam Planner radiation therapy planning system. 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 SRS section on system boundaries and external dependencies for RetinaStim Visual Prosthesis Controller, a Class C Retinal Prosthesis Controller Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware driving a retinal implant electrode array based on camera input processing. Stimulation errors could cause retinal damage.

[Assistant] Content: External dependencies of the RetinaStim Visual Prosthesis Controller include the Custom FPGA + ARM Cortex-M7 operating environment, miniature camera, and RF coil to implant. The Retinal Prosthesis Controller Firmware 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 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 addresses IEC 62304 Clause Annex B.3 for user acceptance testing and Clause 5.3.7 for data archival."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses Annex B.3 and 5.3.7, neither of which exists. IEC 62304 annexes are not cited as requirements. Clause 5.3 has 5.3.1 through 5.3.6 only. All clause references must be corrected.


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

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

"Applicable standards for the StepTrack 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 AutoDose TPN (total parenteral nutrition calculator, Class C):

"The AutoDose TPN architecture is defined. The AutoDose TPN architecture is documented. The AutoDose TPN architecture is verified. The AutoDose TPN architecture is reviewed. The AutoDose TPN architecture is approved."

[Assistant]
Verdict: FAIL
Note: The documentation section exhibits repeated project name. The project name 'AutoDose TPN' appears excessively. Sentences repeat the same assertion about the total parenteral nutrition calculator in different words. Content should be consolidated and each sentence should contribute unique, specific information about the AutoDose TPN.


[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 development follows IEC 62304-6 for the software lifecycle."

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


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

[User]
Write a TRACE section on gap identification and coverage analysis for PaceSet Pacemaker Programmer, a Class C Cardiac Pacemaker Programmer Software. Reference IEC 62304 Clause 5.7.4.
Desktop software for interrogating and programming cardiac pacemakers via telemetry wand. Incorrect programming could cause pacing failure.

[Assistant] Content: Coverage analysis for the PaceSet Pacemaker Programmer per Clause 5.7.4 confirms that every SRS requirement maps to at least one test case with a passing result. Requirements implementing risk controls are additionally confirmed to have adequate test coverage. The Cardiac Pacemaker Programmer Software release is contingent on 100% requirement coverage with no open gaps.


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

[User]
Write a SDP section on internal SOPs and procedures for MindCalm Meditation Timer, a Class A Meditation Wellness App. Reference IEC 62304 Clause 5.1.2.
Mobile app providing guided meditation timers with optional heart rate display during sessions. Heart rate shown for interest only, not diagnostic.

[Assistant] Content: Internal procedures governing MindCalm Meditation Timer development include SOP-010 (Software Development Planning), SOP-011 (Risk Management Planning), SOP-012 (Configuration Management), and SOP-013 (Software Verification Planning). These standard operating procedures are maintained under the company's ISO 13485 quality management system and provide detailed work instructions for each lifecycle activity.


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

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

"The LabView Portal architecture identifies segregation necessary for risk control per Clause 5.3.5."

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

[User]
Review this documentation excerpt for the CardioPulse Monitor (cardiac rhythm monitor, Class B):

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

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the CardioPulse Monitor (cardiac rhythm monitor, Class B). 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 RadView DICOM (DICOM image viewer, Class A):

"System testing for the RadView DICOM verifies that all software requirements are met in the operational environment. Test failures trigger the software problem resolution process per Clause 9. No unit-level or integration-level tests are required for this Class A DICOM image viewer."

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


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

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

"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 CaloriePal development complies with all applicable clauses for Class A."

[Assistant]
Verdict: PASS
Note: Content correctly limits Class A to system-level verification; uses the correct IEC 62304 citation; correctly references ISO 14971:2019. Standards references are accurate.


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

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

"The lifecycle processes for the StepTrack comply with IEC 62304:2020."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304:2020" which is incorrect. No 2020 edition exists. Current: IEC 62304:2006+AMD1:2015. All references must be corrected.


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

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

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

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


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

[User]
Write a SRS section on enhanced security for Class B and C for AnticoagCalc INR Dose Adjuster, a Class B Anticoagulation Dosing Support Tool. Reference IEC 62304 Clause 5.2.2.
Web tool suggesting warfarin dose adjustments based on INR readings and patient history. Clinical decision support requiring physician review.

[Assistant] Content: The Class B/C AnticoagCalc INR Dose Adjuster requires enhanced security controls beyond baseline requirements. The Anticoagulation Dosing Support Tool implements mutual authentication for all external interfaces, firmware integrity verification at startup, and secure update mechanisms. Vulnerability management follows IEC 81001-5-1:2021 throughout the product lifecycle.


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

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

"As Class A software, the SleepWell follows a streamlined verification approach. System tests are traced to software requirements and executed in the intended operating environment. Test records include pass/fail status, date, and tester identity per Clause 5.7.5. No code coverage metrics are mandated."

[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 SAD section on interface design between software items for TriagePro Emergency Scoring App, a Class B Emergency Department Triage SaMD. Reference IEC 62304 Clause 5.3.2.
Standalone tablet app implementing Manchester Triage System scoring. Guides clinicians through triage flowchart and records patient acuity level.

[Assistant] Content: Software item interfaces in the TriagePro Emergency Scoring App architecture are specified per Clause 5.3.2 with sufficient detail to support independent implementation and verification. Each interface definition includes data format, timing constraints, and error handling contracts applicable to the Emergency Department Triage SaMD.


[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 elicitation and documentation for HemaCount Digital Cell Counter, a Class B IVD Digital Cell Counter Software. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Desktop software performing automated differential white blood cell counting on digitized blood smear images using computer vision.

[Assistant] Content: Requirements for the HemaCount Digital Cell Counter 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 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):

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

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


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

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

"The NeuroStim Programmer development follows full Class C rigor: detailed design documentation, unit testing with coverage targets (statement 90%, branch 80%, MC/DC 80%), integration testing of all interfaces, system testing, and independent verification. All activities are traceable to requirements."

[Assistant]
Verdict: PASS
Note: Content correctly specifies full Class C rigor; correctly specifies independent review for Class C. Standards references are accurate.


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

[User]
Write a FMEA section on risk control verification for NeoVent Neonatal Ventilator, a Class C Neonatal Ventilator Firmware. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Neonatal ventilator firmware supporting CPAP, NIPPV, and conventional ventilation for extremely premature infants. Tidal volumes as low as 2 mL.

[Assistant] Content: Verification of NeoVent Neonatal Ventilator risk controls per Clause 7.3.1 is performed as part of the applicable verification level for the safety class. Each verified control has a documented result per Clause 7.3.3, confirming the Neonatal Ventilator Firmware meets the risk acceptability criteria.


[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 HydroRemind Hydration Tracker, a Class A Hydration Tracking Firmware. Reference IEC 62304 Clause 8.1.2.
Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

[Assistant] Content: The HydroRemind Hydration Tracker SOUP register identifies every third-party component deployed in the Hydration Tracking Firmware, including version, source, and functional role. Updates to SOUP items trigger re-evaluation of known anomalies per Clause 7.1.3 and regression testing proportional to the scope of change.


[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 ChemoFlow Infusion Controller, a Class C Chemotherapy Infusion Pump Firmware. Reference IEC 62304 Clause 5.2.1.
Firmware for a chemotherapy infusion pump controlling precise drug delivery rates. Dosing errors could be life-threatening.

[Assistant] Content: The SRS for the ChemoFlow Infusion Controller documents every functional, performance, interface, and safety requirement governing the Chemotherapy Infusion Pump Firmware. Requirements originate from the system specification, the ISO 14971 risk analysis, and regulatory requirements. Traceability per Clause 5.2.1 links each requirement to its source and forward to its verification activity.


[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):

"The ThermoGuard follows the software lifecycle. The ThermoGuard implements the lifecycle processes. The ThermoGuard adheres to the lifecycle model. The ThermoGuard conforms to the lifecycle framework."

[Assistant]
Verdict: FAIL
Note: The documentation section exhibits repeated project name. The project name 'ThermoGuard' appears excessively. Sentences repeat the same assertion about the body temperature logger in different words. Content should be consolidated and each sentence should contribute unique, specific information about the ThermoGuard.


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

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

"System testing for the MedInventory is conducted per Clause 5.7.1 through 5.7.5. Test procedures verify end-to-end functionality of the medical supply tracking system against approved requirements. Detailed design verification (Clause 5.4), unit verification (Clause 5.5), and integration testing (Clause 5.6) are excluded as not applicable to Class A."

[Assistant]
Verdict: PASS
Note: Content correctly limits Class A to system-level verification; includes all required verification levels. 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 DialysisGuard (hemodialysis machine controller, Class C):

"Software problem resolution follows ISO 14971-2 Clause 9."

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


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

[User]
Write a SRS section on system boundaries and external dependencies for AnticoagCalc INR Dose Adjuster, a Class B Anticoagulation Dosing Support Tool. Reference IEC 62304 Clause 5.2.2.
Web tool suggesting warfarin dose adjustments based on INR readings and patient history. Clinical decision support requiring physician review.

[Assistant] Content: External dependencies of the AnticoagCalc INR Dose Adjuster include the Web application operating environment, input hardware, and FHIR Observation API. The Anticoagulation Dosing Support Tool requirements assume these dependencies operate within their specified parameters; failure modes of external components are addressed in the risk analysis.


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

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

"As Class A software, the BloodBank Manager follows a streamlined verification approach. System tests are traced to software requirements and executed in the intended operating environment. Test records include pass/fail status, date, and tester identity per Clause 5.7.5. No code coverage metrics are mandated."

[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 SAD section on SOUP risk evaluation and anomaly management for InsuPrecise Insulin Pump Controller, a Class C Insulin Pump Controller Firmware. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Embedded firmware controlling insulin delivery in a patch-type insulin pump. Incorrect dosing could cause severe hypoglycemia or diabetic ketoacidosis.

[Assistant] Content: Risk evaluation of SOUP in the InsuPrecise Insulin Pump Controller follows Clause 7.1.3. Published anomaly lists are reviewed for each SOUP item deployed in the Insulin Pump Controller Firmware. Anomalies relevant to Automated insulin delivery control with programmable basal rates and bolus calculations are entered into the risk management file, and mitigations are implemented where the residual risk is unacceptable.


[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 SOUP identification and management for GlucoSpot Continuous Glucose Display, a Class B CGM Display App. Reference IEC 62304 Clause 8.1.2.
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 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 CGM Display App.


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

[User]
Expand requirement SRS-SAFE-001: "fault response and safe shutdown" (Category: safety)
Project: GlucoEdge Continuous Glucose Platform | Hybrid CGM Edge-Cloud Platform | Class B
Continuous glucose monitoring with edge processing on wearable and cloud-based trend analysis for clinician review. Hybrid system: embedded BLE firmware on a wearable CGM patch streams readings to a phone app, which uploads to cloud for trend analysis and physician dashboard.

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 detection of a critical software fault, the GlucoEdge Continuous Glucose Platform shall transition to its defined safe state within the specified time, disabling any active output that could contribute to harm.
Rationale: A deterministic safe-state transition prevents the Hybrid CGM Edge-Cloud Platform from operating in an unknown or hazardous state after a detected fault.
Priority: Mandatory
Acceptance Criterion: Safe state transition completes within the specified time limit for each defined critical fault, verified by fault injection during operation.
Source: Risk control


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

[User]
Write a SRS section on data retention and integrity requirements for AutoclaveLog Cycle Recorder, a Class A Sterilization Cycle Data Logger. Reference IEC 62304 Clause 5.2.2.
PC software recording autoclave cycle data (time, temperature, pressure) and generating compliance reports.

[Assistant] Content: The AutoclaveLog Cycle Recorder Sterilization Cycle Data Logger data requirements address storage, integrity, and lifecycle management. All persistent data is validated on read, and write operations use atomic commit mechanisms to prevent partial updates during Recording and reporting autoclave sterilization cycle parameters.


[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 purpose of the SRS document for InhaleSense Smart Inhaler Tracker, a Class A Smart Inhaler Adherence Tracker. Reference IEC 62304 Clause 5.2.1.
Firmware for a smart inhaler attachment detecting actuation events, tracking medication adherence, and syncing data to a mobile app and clinician portal.

[Assistant] Content: This document specifies the software requirements for the InhaleSense Smart Inhaler Tracker Smart Inhaler Adherence Tracker as required by IEC 62304 Clause 5.2.1. It serves as the primary input to design and the primary reference for verification test case derivation. All requirements are verifiable, traceable, and configuration-controlled.


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

[User]
Write a SRS section on data processing and transformation requirements for DoseLog Radiation Badge Reader, a Class A Dosimetry Data Logger. Reference IEC 62304 Clause 5.2.2.
Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

[Assistant] Content: The DoseLog Radiation Badge Reader data pipeline requirements specify end-to-end data flow from dosimeter badge reader through processing to output on USB. Requirements include input validation, range checking, unit conversion, and output formatting for Reading and archiving personal radiation exposure data from dosimeter badges.


[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):

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

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


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

[User]
Write a TRACE section on purpose and scope of the traceability matrix for StepSync Activity Tracker, a Class A Wellness Activity Display App. Reference IEC 62304 Clause 5.7.1.
Mobile app displaying daily step count, distance, and calories from a wrist-worn accelerometer. Read-only display with no clinical interpretation.

[Assistant] Content: Traceability for the StepSync Activity Tracker per Clause 5.7.1 links system requirements to software requirements, software requirements to design elements, and design elements to verification test cases. The matrix serves as the primary evidence that the Wellness Activity Display App verification is complete and that no requirement is unaddressed.


[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: "audit trail and data export" (Category: functional)
Project: DoseVerify In-Vivo Dosimetry System | In-Vivo Dosimetry Verification Software | Class C
Real-time verification of delivered radiation dose using in-vivo dosimeter measurements during treatment. Software calculating real-time delivered dose from in-vivo dosimeter readings during radiation therapy. Dose verification for patient safety.

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 DoseVerify In-Vivo Dosimetry System shall log measurement data with timestamps to non-volatile storage and provide a mechanism to retrieve logged data via electrometer readout.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the In-Vivo Dosimetry Verification Software.
Priority: Desirable
Acceptance Criterion: Data retrieval produces complete, uncorrupted records for the full specified retention period.
Source: User need


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

[User]
Write a SDP section on risk control requirements traceability for WeightAlert Neonatal Scale, a Class B Neonatal Scale Firmware. Reference IEC 62304 Clause 5.2.3.
Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

[Assistant] Content: Software-implemented risk controls for the WeightAlert Neonatal Scale are documented as explicit requirements per Clause 5.2.3. Traceability from the ISO 14971 risk analysis through the SRS to verification test cases ensures that every risk control measure is implemented and verified in the Neonatal Scale Firmware.


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

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

"The WoundTrack development follows IEC 62304-4 for the software lifecycle."

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

[User]
Write a SDP section on problem reporting and investigation for HumidityMap Room Condition Logger, a Class A Environmental Condition Logger. Reference IEC 62304 Clauses 9.1, 9.2.
Network of IoT sensors logging temperature and humidity across hospital storage areas. Dashboard display for facility management.

[Assistant] Content: The problem resolution process for the HumidityMap Room Condition Logger follows Clauses 9.1 through 9.8. Each problem report is classified by severity, investigated for root cause, and resolved through the change control process. Records are maintained per Clause 9.5, and all resolutions are verified per Clause 9.7 before the Environmental Condition Logger baseline is updated.


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

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

"MC/DC coverage of 80% is required for all safety-critical modules of the SleepWell."

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

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

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

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


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

[User]
Write a SDP section on milestones and phase transition criteria for SterilLog Sterilization Record System, a Class A Sterilization Record Logger. Reference IEC 62304 Clause 5.1.1.
Software logging sterilization cycle parameters from autoclaves. Records temperature, pressure, and time for compliance documentation.

[Assistant] Content: Transition between lifecycle phases requires completion of all phase-gate deliverables and sign-off by the designated reviewers. For the SterilLog Sterilization Record System project, key milestones include the Software Requirements Baseline (all requirements reviewed and traced to system requirements), the Design Freeze (architecture and interfaces finalized), and the Release Readiness Review (all verification complete and anomalies dispositioned).


[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: TransVent Transport Ventilator | Transport Ventilator Firmware | Class C
Mechanical ventilation during patient transport in pre-hospital and inter-hospital settings. Portable transport ventilator firmware for ambulance and helicopter use. Must maintain ventilation under vibration and altitude changes.

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 TransVent Transport Ventilator shall require authentication before allowing modification of device configuration parameters via blower driver.
Rationale: Access control prevents unauthorized modification of the Transport Ventilator Firmware operating parameters.
Priority: Mandatory
Acceptance Criterion: Configuration modification is rejected when attempted without valid credentials, verified across all configurable parameters.
Source: Risk control


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

[User]
Write a SDP section on milestones and phase transition criteria for VibeCheck Vibration Analyzer, a Class A Vibration Analysis Instrument Firmware. Reference IEC 62304 Clause 5.1.1.
Portable vibration analysis firmware for predictive maintenance of industrial rotating machinery. FFT analysis of accelerometer data.

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


[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 DialysisGuard (hemodialysis machine controller, Class C):

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

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