[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 process for SeismicWatch Earthquake Early Warning, a Class A Seismic Early Warning Firmware. Reference IEC 62304 Clauses 8.2, 8.2.1.
Firmware for a network of MEMS accelerometers providing earthquake early warning by detecting P-waves and estimating magnitude.

[Assistant] Content: The change control procedure for the SeismicWatch Earthquake Early Warning mandates that every modification to a controlled configuration item is initiated via a change request per Clause 8.2.1. Each request documents the proposed change, safety impact assessment, affected configuration items, and required re-verification for the Seismic Early Warning 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 system boundaries and external dependencies for NeuroTune DBS Programmer, a Class C Deep Brain Stimulator Programmer App. Reference IEC 62304 Clause 5.2.2.
Tablet application programming deep brain stimulation implants for movement disorders. Stimulation parameter errors could cause neurological harm.

[Assistant] Content: System boundaries for the NeuroTune DBS Programmer are defined at the software interface level. The Deep Brain Stimulator Programmer App receives input from NFC/BLE telemetry and produces output via BLE 5.0. Components beyond these interfaces are outside the scope of this SRS and are addressed in system-level documentation.


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

[User]
Write a SDP section on configuration identification approach for TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clauses 8.1, 8.1.1.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

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


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

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

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

[Assistant]
Description: Communication with the ADXL355 3-axis MEMS accelerometer (low noise) over Ethernet shall include CRC-based error detection, automatic retry, and graceful degradation on persistent failure.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Seismic Early Warning Firmware output.
Priority: Mandatory
Acceptance Criterion: Communication operates without data loss for 72 hours continuously, with automatic recovery from simulated failures within the specified time.
Source: System requirement


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

[User]
Write a SDP section on independent review process for Class C for ChemoFlow Infusion Controller, a Class C Chemotherapy Infusion Pump Firmware. Reference IEC 62304 Clause 5.1.1.
Firmware for a chemotherapy infusion pump controlling precise drug delivery rates. Dosing errors could be life-threatening.

[Assistant] Content: Independent review of ChemoFlow Infusion Controller deliverables is required at every phase gate for Class C. The reviewer verifies that requirements are complete and traceable, the architecture addresses safety requirements, the detailed design is correct, unit coverage targets are met, integration tests cover all interfaces, and system tests cover all SRS requirements for the Chemotherapy Infusion Pump Firmware.


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

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

"The CaloriePal conforms to IEC 62304:2006+AMD1:2015. Safety classification per Clause 4.3 designates this nutrition tracking app as Class A. Risk management follows ISO 14971:2019 with guidance from ISO/TR 24971:2020."

[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 HeartLink (cardiac telemetry system, Class B):

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

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


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

[User]
Expand requirement SRS-INTF-003: "external system data exchange" (Category: interface)
Project: ScreenFlow Population Health Screener | Serverless Population Health Screening SaMD | Class A
Processing population health screening questionnaires and generating risk-stratified follow-up recommendations. Serverless cloud application processing population-level health screening questionnaires and flagging individuals for follow-up based on risk scoring algorithms.

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

[Assistant]
Description: Data interoperability with clinical information systems shall be provided through REST API, supporting standard message formats.
Rationale: External system connectivity is required for the Serverless Population Health Screening SaMD to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


[System] You are 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 TeleRehab Remote Patient Monitor, a Class B Remote Rehabilitation Platform. Reference IEC 62304 Clause 5.1.1.
Platform enabling remote physiotherapy with video consultations and wearable sensor data streaming. Generates exercise adherence reports.

[Assistant] Content: Phase transitions for the TeleRehab Remote Patient Monitor are gated by documented completion criteria. The Requirements Baseline requires verified, traceable software requirements. The Implementation Freeze requires all code reviewed and committed. The Release Readiness Review requires all verification records complete, all problem reports dispositioned, and the Remote Rehabilitation Platform release package assembled.


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

[User]
Expand requirement SRS-PERF-003: "RAM and storage constraints" (Category: performance)
Project: SurgLog Procedure Documentation App | Surgical Documentation App | Class A
Documentation and review of surgical procedure notes. Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

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 SurgLog Procedure Documentation App memory footprint on iPadOS shall remain within specified limits under worst-case operational scenarios.
Rationale: Memory constraints are fixed by the iPadOS hardware and must be respected to prevent resource exhaustion during operation.
Priority: Mandatory
Acceptance Criterion: Peak RAM usage during worst-case scenario does not exceed the specified limit, with minimum margin remaining.
Source: System requirement


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

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

"Software problem resolution follows IEC 62304-1 Clause 9."

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

[User]
Write a SDP section on system test execution and acceptance for Class A for DreamLog Sleep Monitor, a Class A Sleep Tracking Display App. Reference IEC 62304 Clauses 5.7, 5.7.4.
Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

[Assistant] Content: Test completeness for the DreamLog Sleep Monitor is measured by requirement coverage at the system level only, per Clause 5.7.4. Every requirement in the SRS is covered by at least one system test case executed on iOS/Android. The Sleep Tracking Display App has no unit test or integration test deliverables, consistent with the Class A verification scope.


[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 AllergyCard Patient Allergy Viewer, a Class A Patient Allergy Display. Reference IEC 62304 Clause 5.7.4.
Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

[Assistant] Content: Coverage analysis for the AllergyCard Patient Allergy Viewer 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 Patient Allergy Display release is contingent on 100% requirement coverage with no open gaps.


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

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

"Maintenance activities follow ISO 62304 Clause 6."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 62304" which is incorrect. Wrong prefix. The correct standard is IEC 62304, not ISO 62304. 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 GrowthChart Pediatric Viewer, a Class A Growth Chart Display App. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Web app displaying pediatric growth charts with WHO/CDC percentile curves. Plots measurements, no diagnostic interpretation.

[Assistant] Content: The GrowthChart Pediatric Viewer FMEA documents each failure mode per Clause 7.1.4, providing sufficient detail for risk evaluation: the software function affected, the failure mode, the cause(s), the effect on the Growth Chart Display App output, and the resulting hazard severity. This documentation is maintained in the risk management file.


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

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

"Cybersecurity considerations are addressed as applicable to the skin lesion classifier. Controls are implemented following industry best practices and guidance."

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


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

[User]
Expand requirement SRS-PERF-002: "end-to-end processing latency" (Category: performance)
Project: DreamLog Sleep Monitor | Sleep Tracking Display App | Class A
Visualizing sleep quality data for personal wellness awareness. Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

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

[Assistant]
Description: End-to-end latency from PPG sensor data acquisition to output presentation shall not exceed the specified limit under normal operating conditions.
Rationale: Real-time performance is critical for the Sleep Tracking Display App to support timely clinical decisions based on current data.
Priority: Mandatory
Acceptance Criterion: Worst-case latency measured under maximum load conditions does not exceed the specified absolute maximum.
Source: System requirement


[System] You are 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 BrachyDose HDR Afterloader Controller, a Class C HDR Brachytherapy Afterloader Firmware. Reference IEC 62304 Clause 5.1.2.
Firmware controlling high-dose-rate brachytherapy source positioning and dwell times. Source positioning errors cause lethal local radiation.

[Assistant] Content: Work instructions for the BrachyDose HDR Afterloader Controller are codified in SOPs maintained within the ISO 13485 quality management system. SOP-010 (development planning), SOP-011 (risk management), SOP-012 (configuration management), and SOP-013 (verification) define step-by-step procedures for each IEC 62304 lifecycle activity applicable to the HDR Brachytherapy Afterloader Firmware.


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

[User]
Expand requirement SRS-PERF-001: "end-to-end processing latency" (Category: performance)
Project: PainScale Digital Assessment Tool | Pain Assessment Tool | Class B
Standardized pain intensity and quality assessment with longitudinal tracking for treatment evaluation. Web app for standardized pain assessment using validated scales (VAS, NRS, McGill). Records longitudinal pain data for treatment monitoring.

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 Pain Assessment Tool shall be bounded to ensure timely output that reflects current input conditions.
Rationale: Real-time performance is critical for the Pain Assessment Tool to support timely clinical decisions based on current data.
Priority: Mandatory
Acceptance Criterion: End-to-end latency is within the specified limit for 99.9% of samples over a 24-hour test period.
Source: System requirement


[System] You are 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 SterilLog Sterilization Record System, a Class A Sterilization Record Logger. Reference IEC 62304 Clause 5.7.1.
Software logging sterilization cycle parameters from autoclaves. Records temperature, pressure, and time for compliance documentation.

[Assistant] Content: The SterilLog Sterilization Record System traceability matrix provides end-to-end requirement coverage evidence per Clause 5.7.1. Every SRS requirement for the Sterilization Record Logger is traced to its implementing software item and to the verification test case(s) confirming correct implementation. Orphaned requirements and untested implementations are flagged for resolution.


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

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

"The SleepWell coding standards require Test-Driven Development. All code shall have corresponding unit tests achieving 80% branch coverage before merge."

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


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

[User]
Write a SRS section on baseline security requirements for SurgiPlan 3D Surgical Planner, a Class B 3D Surgical Planning SaMD. Reference IEC 62304 Clause 5.2.2.
Desktop SaMD for orthopedic surgeons to plan joint replacement procedures on 3D CT reconstructions. Outputs implant sizing and positioning specifications.

[Assistant] Content: The SurgiPlan 3D Surgical Planner security requirements cover confidentiality, integrity, and availability of the 3D Surgical Planning SaMD and its data per IEC 81001-5-1:2021. Requirements specify access control mechanisms, encryption for data at rest and in transit, session management, and audit logging.


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

[User]
Write a SRS section on requirements conventions and identification scheme for RadView DICOM Viewer, a Class A Medical Image Viewer. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Desktop application for viewing DICOM medical images. Display-only with standard windowing controls. No CAD or diagnostic measurement tools.

[Assistant] Content: Requirements for the RadView DICOM Viewer Medical Image Viewer are documented per Clause 5.2.2 with clear acceptance criteria enabling direct derivation of test cases. Each requirement traces backward to its source and forward to its verification activity in the traceability matrix.


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

[User]
Write a SDP section on hazard identification for the specific device for CardioLoop Cardiac Resync Controller, a Class C CRT Optimization Firmware. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Firmware for cardiac resynchronization therapy devices optimizing biventricular pacing based on hemodynamic feedback.

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


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

[User]
Expand requirement SRS-INTF-001: "external system data exchange" (Category: interface)
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: Data interoperability with clinical information systems shall be provided through I2C, supporting standard message formats.
Rationale: Interoperability enables integration of Pulse Oximeter Firmware data into the clinical workflow and patient record.
Priority: Desirable
Acceptance Criterion: Format validation passes for all message types with correct field encoding verified.
Source: User need


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

[User]
Write a SDP section on risk control requirements traceability for MindCalm Meditation Timer, a Class A Meditation Wellness App. Reference IEC 62304 Clause 5.2.3.
Mobile app providing guided meditation timers with optional heart rate display during sessions. Heart rate shown for interest only, not diagnostic.

[Assistant] Content: The MindCalm Meditation Timer requirements include risk control measures traced from the ISO 14971 risk analysis per Clause 5.2.3. Each risk control implemented in software is expressed as a verifiable requirement and traced forward to design, implementation, and verification of the Meditation Wellness App.


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

[User]
Write a TRACE section on traceability scope including risk controls for ConsentView Informed Consent Archive, a Class A Consent Document Viewer. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Web portal for patients and staff to view signed informed consent documents. Read-only document viewer.

[Assistant] Content: Traceability for the ConsentView Informed Consent Archive Consent Document Viewer covers all software requirements per Clause 5.7.1 and all software-implemented risk controls per Clause 7.3.2. The combined matrix provides a single view of verification completeness for functional and safety aspects.


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

[User]
Write a SDP section on scope boundaries of the software system for HemaCount Digital Cell Counter, a Class B IVD Digital Cell Counter Software. Reference IEC 62304 Clauses 5.1.1, 5.1.2.
Desktop software performing automated differential white blood cell counting on digitized blood smear images using computer vision.

[Assistant] Content: This plan applies to all software executing within the HemaCount Digital Cell Counter IVD Digital Cell Counter Software and its supporting build and verification infrastructure. External systems that exchange data with the IVD Digital Cell Counter Software via USB camera are covered only at the interface boundary; their internal implementation is outside the scope of this SDP.


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

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

"The RadView DICOM integration test plan covers all inter-module interfaces per Clause 5.6."

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


[System] You are 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 SterilLog Sterilization Record System, a Class A Sterilization Record Logger. Reference IEC 62304 Clause 5.7.4.
Software logging sterilization cycle parameters from autoclaves. Records temperature, pressure, and time for compliance documentation.

[Assistant] Content: The gap analysis for the SterilLog Sterilization Record System identifies any software requirements without linked test cases, design elements without source requirements (orphan implementations), and test cases that do not trace to any requirement (unnecessary tests). All gaps are documented and resolved before the Release Readiness Review to confirm that the Sterilization Record Logger verification is complete per Clause 5.7.4.


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

[User]
Write a SDP section on development platform and build infrastructure for AssetTrack Equipment Inventory, a Class A Equipment Inventory System. Reference IEC 62304 Clause 5.1.4.
Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management only.

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


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

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

"The NurseCall Hub development follows ISO 14971-1 for the software lifecycle."

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


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

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

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

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


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

[User]
Write a SDP section on cybersecurity and health IT standards for IncidentReport Clinical Event Logger, a Class A Incident Reporting System. Reference IEC 62304 Clause 5.1.2.
Web form for staff to submit clinical incident reports. Data entry and routing only, no analysis.

[Assistant] Content: The IncidentReport Clinical Event Logger cybersecurity posture is defined per IEC 81001-5-1:2021, covering threat modeling, secure design, vulnerability management, and incident response for the Incident Reporting System. Health software product safety requirements from IEC 82304-1:2016 supplement the IEC 62304 lifecycle where applicable.


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

[User]
Write a SRS section on external system communication requirements for ScheduleSync Appointment Manager, a Class A Appointment Scheduling System. Reference IEC 62304 Clause 5.2.2.
Web application for scheduling patient appointments across multiple clinics. Administrative scheduling only, no clinical workflow.

[Assistant] Content: Requirements for external system integration with the ScheduleSync Appointment Manager specify the API contracts, data formats, and error handling behavior for all outbound communication from the Appointment Scheduling System. The software must handle connection timeouts, malformed responses, and authentication failures without affecting safety-relevant functions.


[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 architecture verification scope for RespiRate Respiratory Monitor, a Class B Respiratory Rate Monitor Firmware. Reference IEC 62304 Clauses 5.3.1, 5.3.6.
Wearable firmware monitoring respiratory rate via chest impedance. Displays rate and alerts on bradypnea/tachypnea.

[Assistant] Content: This architecture is subject to verification per Clause 5.3.6 before the RespiRate Respiratory Monitor proceeds to implementation. Reviewers confirm that the architecture addresses all SRS requirements, interfaces are fully specified, and SOUP items are integrated per Clause 5.3.3.


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

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

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

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


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

[User]
Write a SDP section on SOUP identification and management for FridgeGuard Temperature Logger, a Class A Cold Chain Temperature Logger. Reference IEC 62304 Clause 8.1.2.
Firmware logging refrigerator temperatures for vaccine and medication cold chain compliance. Records and displays data, no alerts that drive clinical decisions.

[Assistant] Content: All software of unknown provenance used in the FridgeGuard Temperature Logger is identified and documented per Clause 8.1.2. For each SOUP component, the name, version, manufacturer, and intended use within the Cold Chain Temperature Logger are recorded. Known anomaly lists for each SOUP item are evaluated during risk analysis per Clause 7.1.3.


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

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

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

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


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

[User]
Write a SAD section on architectural overview for Class B for PainScale Digital Assessment Tool, a Class B Pain Assessment Tool. Reference IEC 62304 Clauses 5.3.1, 5.3.2.
Web app for standardized pain assessment using validated scales (VAS, NRS, McGill). Records longitudinal pain data for treatment monitoring.

[Assistant] Content: Architectural design of the PainScale Digital Assessment Tool uses a modular decomposition that separates input handling, business logic, and output generation. Each module has a defined interface per Clause 5.3.2. The Pain Assessment Tool architecture on Web SPA facilitates integration testing at module boundaries.


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

[User]
Expand requirement SRS-SAFE-001: "safe state transition on critical failure" (Category: safety)
Project: BeamPlan Radiation Treatment Planner | Radiation Treatment Planning Software | Class C
Calculating optimal radiation beam configurations and dose distributions for cancer treatment. Desktop software calculating radiation treatment plans including beam angles, dose distribution, and organ-at-risk constraints.

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

[Assistant]
Description: The Radiation Treatment Planning 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: A deterministic safe-state transition prevents the Radiation Treatment Planning Software from operating in an unknown or hazardous state after a detected fault.
Priority: Mandatory
Acceptance Criterion: All 20 defined fault scenarios result in correct safe-state entry within timing limits across 10 iterations each.
Source: Risk control


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

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

[Assistant] Content: The LabStream LIS Middleware shall meet defined latency bounds for all safety-relevant processing paths. Throughput requirements specify the data rates the Laboratory Information Middleware must sustain from input sources without data loss or processing backlog on Linux server (Docker).


[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):

"Software unit acceptance criteria for the BloodBank Manager include boundary value testing, equivalence partitioning, and error guessing per Clause 5.5.3."

[Assistant]
Verdict: FAIL
Note: Content mandates unit acceptance criteria per Clause 5.5.3 for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Unit verification and acceptance criteria (Clause 5.5) are not required for Class A.


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

[User]
Write a SDP section on cybersecurity and health IT standards for MedImage PACS Viewer, a Class A Web PACS Image Viewer. Reference IEC 62304 Clause 5.1.2.
Web-based PACS viewer enabling radiologists to review DICOM images with standard tools (windowing, measurement, MPR). View-only, no AI or diagnostic processing.

[Assistant] Content: Cybersecurity requirements for the MedImage PACS Viewer follow IEC 81001-5-1:2021 for health software and health IT systems security, addressing the full product lifecycle of the Web PACS Image Viewer from design through decommissioning. Where the software is classified as health software running on general-purpose platforms, IEC 82304-1:2016 applies to the overall product safety.


[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):

"Maintenance activities follow ISO 14901 Clause 6."

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


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

[User]
Expand requirement SRS-DATA-001: "stored data corruption detection" (Category: data)
Project: RadOnco Cloud Treatment Planner | Cloud Radiation Treatment Planning SaMD | Class C
Cloud-based Monte Carlo dose calculation and treatment plan optimization for radiation oncology. Cloud-based radiation oncology treatment planning system using GPU clusters for Monte Carlo dose calculation. Treatment plans directly drive linear accelerator delivery.

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 RadOnco Cloud Treatment Planner shall detect corrupted measurement records through integrity checking and flag affected entries for review.
Rationale: Data integrity mechanisms ensure measurement records retrieved from the Cloud Radiation Treatment Planning SaMD are trustworthy for clinical review.
Priority: Mandatory
Acceptance Criterion: Intentionally corrupted records are detected and flagged with 100% detection rate across 100 injected corruption events.
Source: System requirement


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

[User]
Write a TRACE section on gap identification and coverage analysis for LabView Results Portal, a Class A Laboratory Results Viewer. Reference IEC 62304 Clause 5.7.4.
Web application displaying laboratory test results retrieved from the hospital LIS. Read-only viewer with no result interpretation or flagging.

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


[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 FactoryTemp Industrial Temperature Monitor, a Class A Industrial Temperature Monitoring Firmware. Reference IEC 62304 Clause 5.1.1.
Firmware monitoring factory floor temperatures from distributed thermocouple arrays. Logs data for process control compliance.

[Assistant] Content: Transition between lifecycle phases requires completion of all phase-gate deliverables and sign-off by the designated reviewers. For the FactoryTemp Industrial Temperature Monitor 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 an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on configuration identification approach for FridgeGuard Temperature Logger, a Class A Cold Chain Temperature Logger. Reference IEC 62304 Clauses 8.1, 8.1.1.
Firmware logging refrigerator temperatures for vaccine and medication cold chain compliance. Records and displays data, no alerts that drive clinical decisions.

[Assistant] Content: Configuration items for the FridgeGuard Temperature Logger Cold Chain Temperature Logger are identified and placed under version control per Clause 8.1. The configuration baseline includes all items needed to reproduce the released software: source code, build scripts, third-party libraries, and the documentation set.


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

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

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

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


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

[User]
Write a SRS section on resource constraints and scalability for InhaleSense Smart Inhaler Tracker, a Class A Smart Inhaler Adherence Tracker. Reference IEC 62304 Clause 5.2.2.
Firmware for a smart inhaler attachment detecting actuation events, tracking medication adherence, and syncing data to a mobile app and clinician portal.

[Assistant] Content: Computational resource requirements for the InhaleSense Smart Inhaler Tracker define the maximum CPU utilization, RAM consumption, and flash/disk usage permitted on nRF52832 (firmware) + iOS/Android (app). The Smart Inhaler Adherence Tracker must meet all functional and timing requirements within these resource envelopes.


[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 ChemoCalc (chemotherapy dose calculator, Class C):

"Documentation is prepared in accordance with standard templates and guidelines. Review cycles are established at appropriate intervals for the chemotherapy dose calculator."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "appropriate intervals" provide no project-specific information about the ChemoCalc chemotherapy dose calculator. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

[User]
Expand requirement SRS-DATA-003: "data integrity validation" (Category: data)
Project: BreathEasy Air Quality Display | Environmental Air Quality Display | Class A
Informational display of indoor air quality metrics for general awareness. Indoor air quality monitor displaying PM2.5, CO2, and temperature on an LCD. Informational display only with no clinical guidance.

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

[Assistant]
Description: The BreathEasy Air Quality Display shall detect corrupted measurement records through integrity checking and flag affected entries for review.
Rationale: Corrupted data must be identified to prevent clinical decisions based on unreliable measurements.
Priority: Mandatory
Acceptance Criterion: Intentionally corrupted records are detected and flagged with 100% detection rate across 100 injected corruption events.
Source: System requirement


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

[User]
Write a SDP section on risk control requirements traceability for HemaCount Digital Cell Counter, a Class B IVD Digital Cell Counter Software. Reference IEC 62304 Clause 5.2.3.
Desktop software performing automated differential white blood cell counting on digitized blood smear images using computer vision.

[Assistant] Content: Software-implemented risk controls for the HemaCount Digital Cell Counter 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 IVD Digital Cell Counter Software.


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

[User]
Write a SAD section on architectural overview for Class C with segregation for PainRelief PCA Pump Controller, a Class C PCA Pump Controller Firmware. Reference IEC 62304 Clauses 5.3.1, 5.3.2, 5.3.5.
Patient-controlled analgesia pump firmware allowing patient-initiated doses within physician-set limits. Overdose prevention is safety-critical.

[Assistant] Content: The PainRelief PCA Pump Controller architecture addresses Class C segregation requirements per Clause 5.3.5 through partitioned execution. Safety-critical software items operate in a protected domain with validated interfaces to the non-critical domain. This design enables independent verification of safety-critical paths and supports the defense-in-depth strategy for the PCA Pump Controller 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 PhysioTrack Rehab (rehabilitation tracking system, Class B):

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

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


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

[User]
Write a SDP section on test records and acceptance criteria for Class B for FallRisk Inpatient Assessment Tool, a Class B Fall Risk Assessment App. Reference IEC 62304 Clauses 5.6.7, 5.7.5.
Web app calculating fall risk scores for inpatients based on mobility, medication, and cognitive assessments.

[Assistant] Content: Acceptance of the FallRisk Inpatient Assessment Tool Fall Risk Assessment App requires documented evidence of successful integration testing (recorded per Clause 5.6.7) and system testing (recorded per Clause 5.7.5). Regression testing per Clause 5.6.6 is performed after each change to the integration baseline to confirm no previously verified behavior has been affected.


[System] You are 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):

"Documentation is prepared in accordance with standard templates and guidelines. Review cycles are established at appropriate intervals for the read-only lab results viewer."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "appropriate intervals" provide no project-specific information about the LabView Portal read-only lab results viewer. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

[User]
Write a SDP section on milestones and phase transition criteria for CogniTest Cognitive Assessment App, a Class B Cognitive Assessment Application. Reference IEC 62304 Clause 5.1.1.
Tablet app administering standardized cognitive screening tests and scoring results. Used by neuropsychologists in clinical settings.

[Assistant] Content: Phase transitions for the CogniTest Cognitive Assessment App are gated by documented completion criteria. The Requirements Baseline requires verified, traceable software requirements. The Implementation Freeze requires all code reviewed and committed. The Release Readiness Review requires all verification records complete, all problem reports dispositioned, and the Cognitive Assessment Application release package assembled.


[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 WeightAlert Neonatal Scale, a Class B Neonatal Scale Firmware. Reference IEC 62304 Clause 8.1.2.
Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

[Assistant] Content: All software of unknown provenance used in the WeightAlert Neonatal Scale is identified and documented per Clause 8.1.2. For each SOUP component, the name, version, manufacturer, and intended use within the Neonatal Scale Firmware are recorded. Known anomaly lists for each SOUP item are evaluated during risk analysis per Clause 7.1.3.


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

[User]
Expand requirement SRS-SEC-001: "user identity verification" (Category: security)
Project: RemotICU Continuous Monitoring Hub | Edge-to-Cloud ICU Monitoring Gateway | Class B
Aggregating bedside monitor data at the edge and streaming to cloud for tele-ICU clinical oversight. Edge gateway collecting data from bedside monitors (SpO2, HR, BP, ventilator) and streaming to cloud for trending, alerting, and tele-ICU review.

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

[Assistant]
Description: The RemotICU Continuous Monitoring Hub shall require authentication before allowing modification of device configuration parameters via HL7v2 ADT/ORU.
Rationale: Unauthorized configuration changes to the Edge-to-Cloud ICU Monitoring Gateway could compromise its intended function or patient safety.
Priority: Mandatory
Acceptance Criterion: Brute-force protection activates after the specified number of failed authentication attempts.
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 configuration identification approach for DreamLog Sleep Monitor, a Class A Sleep Tracking Display App. Reference IEC 62304 Clauses 8.1, 8.1.1.
Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

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


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

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

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

[Assistant]
Description: User authentication shall be enforced for all configuration changes to the PathCloud AI Histology Analyzer, with credential validation before granting access.
Rationale: Unauthorized configuration changes to the Cloud SaMD Histopathology Analysis Platform could compromise its intended function or patient safety.
Priority: Mandatory
Acceptance Criterion: Configuration modification is rejected when attempted without valid credentials, verified across all configurable parameters.
Source: Risk control


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

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

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

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


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

[User]
Write a SDP section on verification strategy for Class A -- system testing only for AirSentry Urban Air Quality Station, a Class A Air Quality Monitoring Station Firmware. Reference IEC 62304 Clauses 5.7, 5.7.1.
IoT firmware for urban air quality monitoring stations measuring PM2.5, NO2, O3, and CO. Publishes data to public API.

[Assistant] Content: The verification plan for the AirSentry Urban Air Quality Station Air Quality Monitoring Station Firmware is scoped to system testing in accordance with Clause 5.7. Test procedures confirm the software meets each documented requirement, including boundary conditions and error handling. The Class A safety classification means unit-level and integration verification activities per Clauses 5.5 and 5.6 are not part of the verification plan.


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

[User]
Write a SDP section on hazard identification for the specific device for DoseLog Radiation Badge Reader, a Class A Dosimetry Data Logger. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

[Assistant] Content: Software-related hazard causes for the DoseLog Radiation Badge Reader Dosimetry Data Logger are documented per Clause 7.1.2 and Clause 7.1.4. Risk control measures per Clause 7.2.1 address each identified cause through input validation, range checking, communication integrity verification, and fail-safe defaults.


[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: "end-to-end processing latency" (Category: performance)
Project: TeleRehab Remote Patient Monitor | Remote Rehabilitation Platform | Class B
Remote physiotherapy monitoring with exercise tracking and therapist-patient video sessions. Platform enabling remote physiotherapy with video consultations and wearable sensor data streaming. Generates exercise adherence reports.

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

[Assistant]
Description: Processing latency of the Remote Rehabilitation Platform shall be bounded to ensure timely output that reflects current input conditions.
Rationale: Real-time performance is critical for the Remote Rehabilitation Platform to support timely clinical decisions based on current data.
Priority: Mandatory
Acceptance Criterion: End-to-end latency is within the specified limit for 99.9% of samples over a 24-hour test period.
Source: System requirement


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

[User]
Expand requirement SRS-SAFE-001: "Class A scope validation" (Category: safety)
Project: GasMonitor Anesthetic Gas Logger | Anesthetic Gas Concentration Logger | Class A
Recording waste anesthetic gas levels for occupational safety documentation. Software logging waste anesthetic gas concentrations in operating rooms for occupational safety compliance. Recording only.

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

[Assistant]
Description: No software path in the GasMonitor Anesthetic Gas Logger shall control therapeutic outputs, modify diagnostic results, or generate clinical alerts, confirming the validity of the Class A safety classification.
Rationale: The Class A classification of the Anesthetic Gas Concentration Logger depends on the software having no path to contribute to a hazardous situation.
Priority: Mandatory
Acceptance Criterion: Code review confirms no software path exists that controls therapeutic outputs, modifies diagnostic results, or generates clinical alerts.
Source: Regulatory


[System] You are a regulatory 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):

"IEC 62304:2015 Section 7.1 requires all software units to be verified."

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


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

[User]
Write a SDP section on change control process for RespiRate Respiratory Monitor, a Class B Respiratory Rate Monitor Firmware. Reference IEC 62304 Clauses 8.2, 8.2.1.
Wearable firmware monitoring respiratory rate via chest impedance. Displays rate and alerts on bradypnea/tachypnea.

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


[System] You are a regulatory 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 WeightAlert Neonatal Scale, a Class B Neonatal Scale Firmware. Reference IEC 62304 Clause 5.2.2.
Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

[Assistant] Content: The WeightAlert Neonatal Scale data format requirements ensure interoperability with external systems connected via SPI, RS-232 to EMR. Data structures, encoding schemes, and byte ordering are fully specified. The Neonatal Scale Firmware handles version mismatches in data formats gracefully.


[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 InhaleSense Smart Inhaler Tracker, a Class A Smart Inhaler Adherence Tracker. Reference IEC 62304 Clause 4.3.
Firmware for a smart inhaler attachment detecting actuation events, tracking medication adherence, and syncing data to a mobile app and clinician portal.

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


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

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

"Testing ensures quality. Testing validates the software. Testing verifies requirements. Testing confirms functionality. Testing demonstrates compliance. Testing is performed for the CaloriePal."

[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 CaloriePal.


[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 documenting failure modes and their effects for RetinaStim Visual Prosthesis Controller, a Class C Retinal Prosthesis Controller Firmware. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Firmware driving a retinal implant electrode array based on camera input processing. Stimulation errors could cause retinal damage.

[Assistant] Content: Documentation of RetinaStim Visual Prosthesis Controller failure modes follows Clause 7.1.4. Each entry in the FMEA register includes: the software item, the failure mode, the potential cause(s), the effect on the Retinal Prosthesis Controller Firmware during Processing camera input and driving retinal implant electrode stimulation patterns for artificial vision, severity and probability ratings, and references to applicable risk control measures.


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

[User]
Write a SDP section on requirements verification approach for AquaGuard Water Quality Monitor, a Class A Water Quality Monitoring Firmware. Reference IEC 62304 Clause 5.2.6.
Firmware for a multi-parameter water quality probe measuring pH, dissolved oxygen, conductivity, and turbidity in rivers and lakes.

[Assistant] Content: The AquaGuard Water Quality Monitor requirements verification checklist per Clause 5.2.6 confirms: no ambiguous requirements, no untestable requirements, no contradictions between requirements, and complete traceability to system requirements and risk controls. The review is documented with reviewer names, findings, and disposition.


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

[User]
Write a SRS section on functional requirements overview for OBDView Diagnostic Display, a Class A Vehicle Diagnostic Display App. Reference IEC 62304 Clause 5.2.2.
Mobile app connecting to vehicle OBD-II port to display engine parameters, fault codes, and emissions data.

[Assistant] Content: Functional requirements for the OBDView Diagnostic Display specify the data processing, user interaction, and output generation capabilities of the Vehicle Diagnostic Display App. Each requirement describes a discrete function the software shall perform during Displaying vehicle diagnostic information from OBD-II interface for driver and mechanic use, with acceptance criteria sufficient to derive verification test cases.


[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 HydroRemind Hydration Tracker, a Class A Hydration Tracking Firmware. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

[Assistant] Content: Third-party software components used in the HydroRemind Hydration Tracker 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 nRF52840 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 RetinaScan Pro (diabetic retinopathy screening AI, Class B):

"Risk control measures are implemented per ISO 62304 Clause 7."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 62304" which is incorrect. Wrong prefix. The correct standard is IEC 62304, not ISO 62304. 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 user interaction requirements for HomeVent BiPAP Controller, a Class C BiPAP Device Firmware. Reference IEC 62304 Clause 5.2.2.
Home bilevel positive airway pressure device firmware. Manages inspiratory/expiratory pressure, leak compensation, and patient triggering.

[Assistant] Content: Interaction requirements for the HomeVent BiPAP Controller specify all user-facing behaviors of the BiPAP Device Firmware: screen layouts, navigation flows, alarm presentation (if applicable), and error messaging. Each interaction requirement includes the trigger condition, the expected system response, and the acceptance criteria for verification.


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

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

"Software release criteria for the DialysisGuard 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 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):

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

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


[System] You are 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 NeuroTune DBS Programmer, a Class C Deep Brain Stimulator Programmer App. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Tablet application programming deep brain stimulation implants for movement disorders. Stimulation parameter errors could cause neurological harm.

[Assistant] Content: Known anomalies in SOUP components used by the NeuroTune DBS Programmer are evaluated per Clause 7.1.3 against the specific usage context of the Deep Brain Stimulator Programmer App. Each known anomaly is assessed for its potential to contribute to a hazardous situation, and risk control measures are implemented where the anomaly is relevant to Programming stimulation parameters of implanted deep brain stimulators for Parkinson's disease management.


[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 GlucoTrack CGM (continuous glucose monitor display, Class B):

"Quality activities are performed in line with relevant standards and guidelines. Reviews and approvals follow established organizational procedures."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "relevant standards", "established organizational procedures" 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 compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

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

"Verification activities follow IEC 62304 Clause Annex B.3 for security testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause Annex B.3 which does not exist. IEC 62304 annexes are not cited as requirements. 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 GlucoTrack CGM (continuous glucose monitor display, Class B):

"Architectural design follows IEC 62304-6 Clause 5.3 for Class B devices."

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

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

"The lifecycle processes for the PhysioTrack Rehab comply with IEC 14971."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 14971" which is incorrect. Wrong prefix. The correct standard is ISO 14971, not IEC 14971. 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 SleepWell (sleep quality display app, Class A):

"This Software Development Plan for the SleepWell is prepared in compliance with IEC 62304:2006+AMD1:2015 and ISO 14971:2019. Usability engineering follows IEC 62366-1:2015+AMD1:2020."

[Assistant]
Verdict: PASS
Note: Content uses the correct IEC 62304 citation; correctly references ISO 14971:2019. 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 development methodology for Class A for FridgeGuard Temperature Logger, a Class A Cold Chain Temperature Logger. Reference IEC 62304 Clause 5.1.1.
Firmware logging refrigerator temperatures for vaccine and medication cold chain compliance. Records and displays data, no alerts that drive clinical decisions.

[Assistant] Content: An iterative development approach with defined phase gates is adopted for the FridgeGuard Temperature Logger, appropriate for the Class A classification where system-level verification is the primary quality gate. Each iteration produces a testable increment of the Cold Chain Temperature Logger functionality, with reviews at Requirements Complete, Implementation Complete, and Release Readiness milestones.


[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 IncidentReport Clinical Event Logger, a Class A Incident Reporting System. Reference IEC 62304 Clauses 9.1, 9.2.
Web form for staff to submit clinical incident reports. Data entry and routing only, no analysis.

[Assistant] Content: Software problems discovered during IncidentReport Clinical Event Logger development are documented as problem reports per Clause 9.1, including a description of the anomaly, steps to reproduce, and the affected configuration item. Investigation per Clause 9.2 determines the root cause, assesses the impact on previously verified items, and identifies whether the problem affects the safety or effectiveness of the Incident Reporting System.


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

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

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

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


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

[User]
Write a SDP section on purpose and scope for Class C with full documentation for BrachyDose HDR Afterloader Controller, a Class C HDR Brachytherapy Afterloader Firmware. Reference IEC 62304 Clause 5.1.1.
Firmware controlling high-dose-rate brachytherapy source positioning and dwell times. Source positioning errors cause lethal local radiation.

[Assistant] Content: All IEC 62304 development activities are in scope for the BrachyDose HDR Afterloader Controller, reflecting its Class C classification. The HDR Brachytherapy Afterloader Firmware processes source position encoder for Controlling radioactive source stepping positions and dwell times for high-dose-rate brachytherapy, and failure could contribute to serious injury. This plan requires detailed design, unit verification with coverage targets, integration testing, system testing, and independent review by personnel not involved in the development 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 ChemoCalc (chemotherapy dose calculator, Class C):

"The ChemoCalc conforms to IEC 62304:2006+AMD1:2015. Safety classification per Clause 4.3 designates this chemotherapy dose 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 PhysioTrack Rehab (rehabilitation tracking system, Class B):

"Hazard analysis for the PhysioTrack Rehab identifies that incorrect display of measurement values could mislead the clinician. Risk control measures include input validation (REQ-SRS-023), display range checking, and a visual indicator when data is stale. Residual risk is acceptable per the risk management plan."

[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 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):

"Cybersecurity considerations are addressed as applicable to the sleep quality display app. Controls are implemented following industry best practices and guidance."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "best practices", "as applicable" provide no project-specific information about the SleepWell sleep quality display app. 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 requirements conventions and identification scheme for AutoclaveLog Cycle Recorder, a Class A Sterilization Cycle Data Logger. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
PC software recording autoclave cycle data (time, temperature, pressure) and generating compliance reports.

[Assistant] Content: Each requirement for the AutoclaveLog Cycle Recorder is assigned a unique identifier and tagged with its type (functional, performance, interface, or safety) per Clause 5.2.2. Requirements are written in "shall" statements that are individually testable. The requirement set is baselined and controlled under the change management process.


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

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

"The BloodBank Manager addresses IEC 62304 Clause 5.6.8 for user acceptance testing and Clause 5.8.9 for detailed design verification."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.6.8 and 5.8.9, neither of which exists. Clause 5.6 has 5.6.1 through 5.6.7 only. Clause 5.8 has 5.8.1 through 5.8.8 only. All clause references must be corrected.


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

[User]
Write a SDP section on independent review process for Class C for StrokeAlert CT Perfusion Analyzer, a Class C AI Stroke Triage CT Perfusion SaMD. Reference IEC 62304 Clause 5.1.1.
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 review process mandates independent technical review for all Class C deliverables. The independent reviewer has competence in C++ (image processing) + Python (ML) + Swift/Kotlin (mobile alerts) development and IEC 62304 compliance but is not a member of the AI Stroke Triage CT Perfusion SaMD development team. Review records include reviewer qualifications, findings, actions taken, and formal sign-off.


[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: "user-configurable operating parameters" (Category: functional)
Project: FetalGuard Heart Rate Monitor | Fetal Heart Rate Monitor Firmware | Class B
Continuous external fetal heart rate monitoring during labor with clinical display. External fetal heart rate monitor firmware using Doppler ultrasound. Displays fetal heart rate and variability during labor.

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 FetalGuard Heart Rate Monitor shall allow authorized users to configure operating parameters via analog signal conditioning and persist settings across power cycles.
Rationale: Parameter flexibility is essential for the Fetal Heart Rate Monitor Firmware to meet varying clinical requirements across deployment sites.
Priority: Mandatory
Acceptance Criterion: All configurable parameters persist correctly across power cycles and reject out-of-range values with appropriate error messages.
Source: User need


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

[User]
Expand requirement SRS-FUNC-004: "data logging and retrieval" (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 log measurement data with timestamps to non-volatile storage and provide a mechanism to retrieve logged data via USB.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Visitor Management System.
Priority: Desirable
Acceptance Criterion: Data retrieval produces complete, uncorrupted records for the full specified retention period.
Source: User need