[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 PhysioTrack Rehabilitation Monitor, a Class B Physical Therapy Tracking System. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

[Assistant] Content: Each identified failure mode of the PhysioTrack Rehabilitation Monitor is documented per Clause 7.1.4 with the failure mode description, potential causes, local effects, end effects on the Physical Therapy Tracking System, severity classification, and existing controls. The documentation supports risk control decision-making per Clause 7.2.1.


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

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

"IEC 62304 Clause 4.5 requires the BloodBank Manager to implement performance benchmarking."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 4.5 which does not exist. Clause 4 only has 4.1, 4.2, 4.3. The reference must be corrected to a valid clause number.


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

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

"Unit verification per IEC 62304 Clause 5.5 requires testing of all MedInventory software units."

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


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

[User]
Write a SRS section on requirements conventions and identification scheme for DreamLog Sleep Monitor, a Class A Sleep Tracking Display App. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

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


[System] You are 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 TempWatch Body Temperature Logger, a Class A Temperature Logging Firmware. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Firmware for a wearable temperature patch that logs skin temperature over 24 hours and displays trends. No fever detection or alerts.

[Assistant] Content: Known anomalies in SOUP components used by the TempWatch Body Temperature Logger are evaluated per Clause 7.1.3 against the specific usage context of the Temperature Logging Firmware. Each known anomaly is assessed for its potential to contribute to a hazardous situation, and risk control measures are implemented where the anomaly is relevant to Passive logging and display of skin temperature trends for personal interest.


[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: DermaAssist Skin Lesion Classifier | Skin Lesion Classification App | Class B
AI-assisted classification of skin lesion images as benign or suspicious for dermatologist review. Mobile app using a CNN to classify skin lesion images as benign/suspicious. Decision support requiring dermatologist confirmation.

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

[Assistant]
Description: Upon detection of a critical software fault, the DermaAssist Skin Lesion Classifier shall transition to its defined safe state within the specified time, disabling any active output that could contribute to harm.
Rationale: Fail-safe behavior is essential to prevent the Skin Lesion Classification App from causing harm when its software detects an unrecoverable error.
Priority: Mandatory
Acceptance Criterion: Safe state transition completes within the specified time limit for each defined critical fault, verified by fault injection during operation.
Source: Risk control


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

[User]
Write a TRACE section on risk control coverage verification for VitalBoard Patient Summary, a Class A Patient Summary Dashboard. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Dashboard displaying patient vital signs history retrieved from the EMR. View-only with no alerting or trend analysis.

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


[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 AirSentry Urban Air Quality Station, a Class A Air Quality Monitoring Station Firmware. Reference IEC 62304 Clauses 8.2, 8.2.1.
IoT firmware for urban air quality monitoring stations measuring PM2.5, NO2, O3, and CO. Publishes data to public API.

[Assistant] Content: No change to the AirSentry Urban Air Quality Station baseline is implemented without an approved change request per Clause 8.2. The approval process evaluates the change's impact on safety, regulatory compliance, and previously verified functionality. Post-implementation verification confirms the change was correctly applied per Clause 8.2.3.


[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 NutriCalc TPN Formulation Tool, a Class B TPN Formulation Calculator. Reference IEC 62304 Clause 5.7.4.
Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

[Assistant] Content: Coverage analysis for the NutriCalc TPN Formulation Tool 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 TPN Formulation Calculator release is contingent on 100% requirement coverage with no open gaps.


[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 requirements conventions and identification scheme for ChestAI Pulmonary Nodule Detector, a Class B AI Pulmonary Nodule Detection SaMD. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Cloud AI SaMD analyzing chest CT scans to detect and measure pulmonary nodules, providing CAD overlay for radiologist review. FDA De Novo pathway.

[Assistant] Content: Requirements for the ChestAI Pulmonary Nodule Detector AI Pulmonary Nodule Detection SaMD 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 a requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-PERF-002: "resource utilization limits" (Category: performance)
Project: PharmLog Medication History Viewer | Medication History Viewer | Class A
Read-only display of medication dispensing history. Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

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 PharmLog Medication History Viewer memory footprint on iOS shall remain within specified limits under worst-case operational scenarios.
Rationale: Exceeding memory limits could cause undefined behavior in the Medication History Viewer, potentially affecting safety.
Priority: Mandatory
Acceptance Criterion: Peak RAM usage during worst-case scenario does not exceed the specified limit, with minimum margin remaining.
Source: System requirement


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

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

"The PillRemind software verification plan specifies system testing as the sole verification activity. Clause 5.5 (unit verification) and Clause 5.6 (integration testing) do not apply to Class A. Test cases verify all software requirements."

[Assistant]
Verdict: PASS
Note: Content correctly limits Class A to system-level verification. 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 tool qualification for Class B and C for PulmoCheck Spirometry Analyzer, a Class B Spirometry Analysis Software. Reference IEC 62304 Clause 5.1.4.
Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

[Assistant] Content: Tool qualification for the PulmoCheck Spirometry Analyzer is performed for all tools whose output directly supports verification conclusions, per Clause 5.1.4. Qualified tools include the C++/Qt build toolchain, code coverage analyzers, and the system test harness. Each tool's qualification record is maintained as a controlled document.


[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: 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: End-to-end latency from ADXL355 3-axis MEMS accelerometer (low noise) data acquisition to output presentation shall not exceed the specified limit under normal operating conditions.
Rationale: Real-time performance is critical for the Seismic Early Warning Firmware to support timely clinical decisions based on current data.
Priority: Mandatory
Acceptance Criterion: Worst-case latency measured under maximum load conditions does not exceed the specified absolute maximum.
Source: System requirement


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

[User]
Write a SDP section on risk control verification and traceability for AllergyCard Patient Allergy Viewer, a Class A Patient Allergy Display. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

[Assistant] Content: The AllergyCard Patient Allergy Viewer risk control traceability matrix per Clause 7.3.2 links every identified hazard cause to its software-implemented control and to the verification activity confirming its effectiveness. Clause 7.3.3 requires documentation of the verification results for each risk control measure applied to the Patient Allergy Display.


[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):

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

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


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

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

"The SleepWell 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 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 CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clause 5.2.2.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: Security requirements for the CochleaMap CI Fitting Software address authentication, data protection, and access control for the Cochlear Implant Fitting Software. All persistent data is encrypted at rest, and data in transit over desktop GUI uses transport layer encryption. Security requirements are aligned with IEC 81001-5-1:2021.


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

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

"IEC 62304 Clause 5.9 requires the CardioPulse Monitor to implement user acceptance testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.9 which does not exist. Clause 5 ends at 5.8. The reference must be corrected to a valid clause number.


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

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

"IEC 62304 Clause 10.1 requires the DialysisGuard to implement post-market surveillance."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 10.1 which does not exist. IEC 62304 has no Clause 10. Standard ends at Clause 9. The reference must be corrected to a valid clause number.


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

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

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

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


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

[User]
Expand requirement SRS-DATA-001: "record keeping duration" (Category: data)
Project: StepSync Activity Tracker | Wellness Activity Display App | Class A
Passive display of physical activity metrics for personal wellness tracking. Mobile app displaying daily step count, distance, and calories from a wrist-worn accelerometer. Read-only display with no clinical interpretation.

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

[Assistant]
Description: The StepSync Activity Tracker shall retain measurement data in non-volatile storage for the specified minimum retention period, after which data may be overwritten.
Rationale: Data retention supports clinical trend analysis and regulatory requirements for record keeping associated with the Wellness Activity Display App.
Priority: Mandatory
Acceptance Criterion: Retention period validation: records created at time T are still accessible at T + retention period.
Source: Regulatory


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

[User]
Write a SDP section on requirements verification approach for AssetTrack Equipment Inventory, a Class A Equipment Inventory System. Reference IEC 62304 Clause 5.2.6.
Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management only.

[Assistant] Content: Requirements verification for the AssetTrack Equipment Inventory is conducted per Clause 5.2.6 before the requirements baseline is established. The review confirms completeness, consistency, and testability. Any requirement failing these criteria is returned for rework before the Equipment Inventory System proceeds to design.


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

[User]
Expand requirement SRS-SAFE-002: "independent watchdog monitoring" (Category: safety)
Project: PaceSet Pacemaker Programmer | Cardiac Pacemaker Programmer Software | Class C
Programming and interrogating implanted cardiac pacemakers including rate settings, sensitivity, and output parameters. Desktop software for interrogating and programming cardiac pacemakers via telemetry wand. Incorrect programming could cause pacing failure.

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: An independent hardware watchdog shall monitor the PaceSet Pacemaker Programmer main processing loop, triggering a safe-state reset if the software fails to service the watchdog within the specified timeout.
Rationale: Hardware-independent monitoring ensures that a frozen main processor cannot leave the Cardiac Pacemaker Programmer Software in an unsafe operating state.
Priority: Mandatory
Acceptance Criterion: Watchdog independence verified: main processor halt results in watchdog-initiated recovery within timing specification.
Source: Risk control


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

[User]
Expand requirement SRS-SAFE-001: "safety classification confirmation for Class A" (Category: safety)
Project: SterilLog Sterilization Record System | Sterilization Record Logger | Class A
Recording and archiving sterilization cycle parameters for regulatory compliance. Software logging sterilization cycle parameters from autoclaves. Records temperature, pressure, and time for compliance documentation.

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 SterilLog Sterilization Record System 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 Sterilization Record 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 an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on risk management integration into the lifecycle for WeatherNode Microclimate Station, a Class A Weather Station Firmware. Reference IEC 62304 Clauses 7.1, 7.1.1.
Solar-powered weather station firmware measuring temperature, humidity, wind, rainfall, and barometric pressure.

[Assistant] Content: Integration of risk management into the WeatherNode Microclimate Station lifecycle ensures that newly identified hazards during development trigger requirement updates, design changes, and additional verification. The risk management file is a living document updated at each phase gate, with traceability maintained per Clause 7.3.2.


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

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

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


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

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

[Assistant] Content: Data exchanged by the BreathEasy Air Quality Display via I2C conforms to defined formats documented in this SRS. The Environmental Air Quality Display validates incoming data against the format specification and rejects malformed messages with a logged error. Output data formats are deterministic and reproducible.


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

[User]
Expand requirement SRS-INTF-002: "external system data exchange" (Category: interface)
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: The Pain Assessment Tool shall support bidirectional data exchange with external systems over web form.
Rationale: Interoperability enables integration of Pain Assessment Tool 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 an IEC 62304 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-FUNC-007: "measurement data archival" (Category: functional)
Project: HydroRemind Hydration Tracker | Hydration Tracking Firmware | Class A
Passive display of daily water consumption for wellness. Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

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

[Assistant]
Description: All processed measurements shall be stored with timestamps in a persistent log accessible through BLE 5.0 for clinical review and regulatory audit.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Hydration Tracking Firmware.
Priority: Desirable
Acceptance Criterion: Data retrieval produces complete, uncorrupted records for the full specified retention period.
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 SAD section on error propagation and data integrity in the pipeline for BrachyDose HDR Afterloader Controller, a Class C HDR Brachytherapy Afterloader Firmware. Reference IEC 62304 Clause 5.3.2.
Firmware controlling high-dose-rate brachytherapy source positioning and dwell times. Source positioning errors cause lethal local radiation.

[Assistant] Content: Error handling in the BrachyDose HDR Afterloader Controller HDR Brachytherapy Afterloader Firmware architecture follows a defense-in-depth principle: each software item validates its inputs independently, even if the upstream item has performed validation. Error propagation is controlled through defined error interfaces per Clause 5.3.2, preventing corruption from spreading across module boundaries.


[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 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: All IEC 62304 development activities are in scope for the ChemoFlow Infusion Controller, reflecting its Class C classification. The Chemotherapy Infusion Pump Firmware processes drop counting sensor for Precision-controlled chemotherapy drug infusion with dose-error detection and safety interlocks, 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 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 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 3D Surgical Planning SaMD external communication requirements cover data exchange with remote systems. Each requirement specifies the message format, transport protocol, retry policy, and failure mode behavior, ensuring the 3D Surgical Planning SaMD degrades safely if communication is disrupted.


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

[User]
Write a SDP section on risk management integration into the lifecycle for MedImage PACS Viewer, a Class A Web PACS Image Viewer. Reference IEC 62304 Clauses 7.1, 7.1.1.
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: The MedImage PACS Viewer risk management process is concurrent with development, not sequential. Software causes of hazardous situations are identified per Clause 7.1 and documented per Clause 7.1.4. Risk controls are implemented as software requirements and verified through the applicable testing levels for the Web PACS Image Viewer.


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

[User]
Expand requirement SRS-FUNC-005: "output refresh interval for PedDose Pediatric Dosing App" (Category: functional)
Project: PedDose Pediatric Dosing App | Pediatric Dosing Calculator App | Class B
Weight-based pediatric dose calculations with age-appropriate range checking. Mobile reference app for pediatric drug dosing with weight-based calculations and age-specific ranges.

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 PedDose Pediatric Dosing App display shall present current readings on local drug database within the specified maximum update latency.
Rationale: Timely display updates ensure the user observes current readings without perceiving lag.
Priority: Mandatory
Acceptance Criterion: Measured display update interval is within 10% of the specified refresh period across 100 consecutive update cycles.
Source: User need


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

[User]
Write a SDP section on risk control requirements traceability for TriagePro Emergency Scoring App, a Class B Emergency Department Triage SaMD. Reference IEC 62304 Clause 5.2.3.
Standalone tablet app implementing Manchester Triage System scoring. Guides clinicians through triage flowchart and records patient acuity level.

[Assistant] Content: The TriagePro Emergency Scoring App 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 Emergency Department Triage SaMD.


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

[User]
Write a TRACE section on risk control coverage verification for AquaGuard Water Quality Monitor, a Class A Water Quality Monitoring Firmware. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
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 gap analysis per Clause 5.7.4 and Clause 7.3.2 verifies that the risk control traceability chain is complete. Every hazard in the risk management file that has a software control must trace to a verified requirement in the Water Quality Monitoring Firmware. Incomplete chains are flagged and resolved before release.


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

[User]
Write a SRS section on data processing and transformation requirements for PowerTrack UPS Monitor, a Class A UPS Monitoring Software. Reference IEC 62304 Clause 5.2.2.
Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

[Assistant] Content: Data processing requirements for the PowerTrack UPS Monitor define the transformations applied to raw input from data sources to produce the output presented to the user. Each transformation has defined accuracy bounds and error handling behavior specific to the UPS Monitoring Software operational context.


[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):

"The MedInventory conforms to IEC 62304:2006+AMD1:2015. Safety classification per Clause 4.3 designates this medical supply tracking system 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 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 CardioCloud ECG Analysis Service, a Class B Cloud ECG Analysis SaMD. Reference IEC 62304 Clause 5.2.3.
Cloud SaaS platform receiving 12-lead ECG recordings from clinics, running automated arrhythmia detection, and returning annotated results via FHIR API.

[Assistant] Content: Risk control measures identified in the ISO 14971 risk management process are traced to specific software requirements per Clause 5.2.3. For the CardioCloud ECG Analysis Service, this includes controls addressing input data failure modes, communication integrity on REST API, and data validation.


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

[User]
Expand requirement SRS-SAFE-002: "fault response and safe shutdown" (Category: safety)
Project: AutoPancreas Closed-Loop Glucose Controller | Artificial Pancreas Controller Firmware | Class C
Automated closed-loop insulin delivery based on continuous glucose monitoring with predictive algorithms. Artificial pancreas firmware integrating CGM readings with insulin pump delivery using a PID control algorithm. Life-sustaining closed-loop system.

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

[Assistant]
Description: Upon detection of a critical software fault, the AutoPancreas Closed-Loop Glucose Controller shall transition to its defined safe state within the specified time, disabling any active output that could contribute to harm.
Rationale: A deterministic safe-state transition prevents the Artificial Pancreas Controller Firmware from operating in an unknown or hazardous state after a detected fault.
Priority: Mandatory
Acceptance Criterion: Safe state transition completes within the specified time limit for each defined critical fault, verified by fault injection during operation.
Source: Risk control


[System] You are 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 AnticoagCalc INR Dose Adjuster, a Class B Anticoagulation Dosing Support Tool. Reference IEC 62304 Clause 5.2.2.
Web tool suggesting warfarin dose adjustments based on INR readings and patient history. Clinical decision support requiring physician review.

[Assistant] Content: The AnticoagCalc INR Dose Adjuster functional requirements define what the Anticoagulation Dosing Support Tool does in response to user inputs, sensor data, and system events. Requirements are organized by functional area: data acquisition, signal processing, display and output, and system management. Each requirement is individually testable.


[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 lightweight review process for Class A for TrainCert Staff Certification Tracker, a Class A Training Certification System. Reference IEC 62304 Clause 5.1.1.
Web app tracking staff training certifications and renewal dates. Administrative HR tool for compliance tracking.

[Assistant] Content: The TrainCert Staff Certification Tracker review process is proportionate to the Class A risk level. The project lead reviews each deliverable for technical accuracy, and the quality representative verifies compliance with SOPs. Reviews are documented but do not require independent technical review of the Training Certification System verification activities.


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

[User]
Expand requirement SRS-SEC-002: "patient data protection" (Category: security)
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: The PainScale Digital Assessment Tool shall encrypt patient-identifiable data at rest, ensuring that raw storage access cannot reveal protected health information.
Rationale: Data-at-rest encryption is required to meet privacy regulations and protect patient confidentiality.
Priority: Mandatory
Acceptance Criterion: Encrypted storage verified by reading raw storage media and confirming no patient-identifiable data is visible without the decryption key.
Source: Regulatory


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

[User]
Write a TRACE section on traceability scope including risk controls for VisitorPass Access Management, a Class A Visitor Management System. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Kiosk application for visitor registration and badge printing in hospital lobbies. Administrative access control.

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

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

"In accordance with IEC 62304:2022, verification activities include system testing."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304:2022" which is incorrect. No 2022 edition exists. Current: 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 FMEA section on failure mode identification approach for SleepScore Apnea Screening Tool, a Class B Sleep Apnea Screening App. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Mobile app analyzing overnight audio recordings to screen for obstructive sleep apnea indicators. Screening only, not diagnostic.

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


[System] You are 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):

"System test procedures for the BloodBank Manager are derived from the software requirements specification. Each test has defined preconditions, steps, and expected results. This is the only verification level required for Class A software."

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


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

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

"MISRA C compliance and unit testing with MC/DC coverage are mandatory for the LabView Portal."

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


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

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

"Compliance with IEC 62304 Clause 5.7.6 is demonstrated through automated regression testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.7.6 which does not exist. Clause 5.7 has 5.7.1 through 5.7.5 only. The reference must be corrected to a valid clause number.


[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: "memory usage budget" (Category: performance)
Project: StepSync Activity Tracker | Wellness Activity Display App | Class A
Passive display of physical activity metrics for personal wellness tracking. Mobile app displaying daily step count, distance, and calories from a wrist-worn accelerometer. Read-only display with no clinical interpretation.

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

[Assistant]
Description: The StepSync Activity Tracker shall operate within the specified RAM and flash memory budget on the iOS/Android platform, including all runtime allocations.
Rationale: Memory constraints are fixed by the iOS/Android hardware and must be respected to prevent resource exhaustion during operation.
Priority: Mandatory
Acceptance Criterion: Peak RAM usage during worst-case scenario does not exceed the specified limit, with minimum margin remaining.
Source: System requirement


[System] You are a regulatory 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 PowerTrack UPS Monitor, a Class A UPS Monitoring Software. Reference IEC 62304 Clauses 8.1, 8.1.1.
Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

[Assistant] Content: Configuration items for the PowerTrack UPS 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 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 AutoPancreas Closed-Loop Glucose Controller, a Class C Artificial Pancreas Controller Firmware. Reference IEC 62304 Clauses 5.3.1, 5.3.6.
Artificial pancreas firmware integrating CGM readings with insulin pump delivery using a PID control algorithm. Life-sustaining closed-loop system.

[Assistant] Content: Architecture verification for the AutoPancreas Closed-Loop Glucose Controller per Clause 5.3.6 confirms traceability from requirements to architectural elements, adequacy of interface definitions, and correct implementation of risk control measures in the Artificial Pancreas Controller Firmware design.


[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 BreathSync ICU Ventilator Controller, a Class C ICU Ventilator Controller Software. Reference IEC 62304 Clause 5.1.1.
Software controlling an ICU mechanical ventilator with multiple ventilation modes (volume, pressure, SIMV). Failure could result in patient death.

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


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

[User]
Expand requirement SRS-SEC-001: "access control and authorization" (Category: security)
Project: StrokeAlert CT Perfusion Analyzer | AI Stroke Triage CT Perfusion SaMD | Class C
Rapid automated CT perfusion analysis generating ischemic core and penumbra maps for acute stroke treatment decisions. 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.

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 StrokeAlert CT Perfusion Analyzer shall require authentication before allowing modification of device configuration parameters via DICOM push from CT scanner.
Rationale: Unauthorized configuration changes to the AI Stroke Triage CT Perfusion SaMD 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 FMEA section on risk control measures and implementation for HumidityMap Room Condition Logger, a Class A Environmental Condition Logger. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Network of IoT sensors logging temperature and humidity across hospital storage areas. Dashboard display for facility management.

[Assistant] Content: Risk control measures for the HumidityMap Room Condition Logger are defined per Clause 7.2.1 and implemented in software per Clause 7.2.2. Controls include input validation for SHT31 temp/humidity, range checking on processed values, and timeout detection on LoRaWAN. Each control is traced to a software requirement and verified through testing.


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

[User]
Write a TRACE section on risk control coverage verification for TrainCert Staff Certification Tracker, a Class A Training Certification System. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Web app tracking staff training certifications and renewal dates. Administrative HR tool for compliance tracking.

[Assistant] Content: Risk control coverage analysis for the TrainCert Staff Certification Tracker per Clause 7.3.2 confirms that every software-implemented risk control has a linked verification result demonstrating its effectiveness. Any risk control without verification evidence is treated as a critical gap blocking release of the Training Certification System.


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

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

[Assistant] Content: Interoperability requirements for the RadView DICOM Viewer specify the data encoding, field definitions, and validation rules for all messages exchanged by the Medical Image Viewer. Each data interface has a defined schema, and the software rejects data that does not conform to the schema with appropriate error reporting.


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

[User]
Write a TRACE section on risk control coverage verification for PharmaSafe CDSS, a Class B Clinical Decision Support System. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Clinical decision support system integrated into hospital EMR providing real-time drug-drug interaction alerts, allergy checking, and dosing guidance.

[Assistant] Content: The PharmaSafe CDSS gap analysis per Clause 5.7.4 and Clause 7.3.2 verifies that the risk control traceability chain is complete. Every hazard in the risk management file that has a software control must trace to a verified requirement in the Clinical Decision Support System. Incomplete chains are flagged and resolved before release.


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

[User]
Write a SDP section on risk management integration into the lifecycle for FridgeGuard Temperature Logger, a Class A Cold Chain Temperature Logger. Reference IEC 62304 Clauses 7.1, 7.1.1.
Firmware logging refrigerator temperatures for vaccine and medication cold chain compliance. Records and displays data, no alerts that drive clinical decisions.

[Assistant] Content: Software risk management activities are integrated throughout the FridgeGuard Temperature Logger development lifecycle in accordance with IEC 62304 Clause 7 and ISO 14971. Risk analysis begins during requirements analysis, with identified hazards traced through design, implementation, and verification to confirm that all risk control measures are effectively implemented and verified.


[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 RenalDose Renal Adjustment Calculator, a Class B Renal Dose Adjustment Calculator. Reference IEC 62304 Clause 5.7.4.
Calculator adjusting medication doses for patients with impaired renal function based on eGFR.

[Assistant] Content: Gap analysis for the RenalDose Renal Adjustment Calculator per Clause 5.7.4 examines the traceability matrix for completeness. Requirements without verification are flagged as critical gaps. Design elements without requirements are evaluated for removal or requirement creation. The Renal Dose Adjustment Calculator cannot be released 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 configuration identification approach for RetinaStim Visual Prosthesis Controller, a Class C Retinal Prosthesis Controller Firmware. Reference IEC 62304 Clauses 8.1, 8.1.1.
Firmware driving a retinal implant electrode array based on camera input processing. Stimulation errors could cause retinal damage.

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


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

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

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

[Assistant]
Description: Access to configuration and administrative functions of the Hybrid CGM Edge-Cloud Platform shall be restricted to authenticated and authorized users.
Rationale: Access control prevents unauthorized modification of the Hybrid CGM Edge-Cloud Platform operating parameters.
Priority: Mandatory
Acceptance Criterion: Configuration modification is rejected when attempted without valid credentials, verified across all configurable parameters.
Source: Risk control


[System] You are 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):

"This Software Development Plan for the FetaSound 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 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):

"Per IEC 62304 Clause 5.2, requirements are defined. Per IEC 62304 Clause 5.2, requirements are documented. Per IEC 62304 Clause 5.2, requirements are analyzed. Per IEC 62304 Clause 5.2, requirements are verified."

[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 FetaSound.


[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):

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

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


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

[User]
Expand requirement SRS-FUNC-006: "device configuration management" (Category: functional)
Project: PharmLog Medication History Viewer | Medication History Viewer | Class A
Read-only display of medication dispensing history. Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

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

[Assistant]
Description: Configuration changes to the PharmLog Medication History Viewer shall be validated against allowed ranges before acceptance and persisted to survive power loss.
Rationale: Parameter flexibility is essential for the Medication History Viewer to meet varying clinical requirements across deployment sites.
Priority: Mandatory
Acceptance Criterion: All configurable parameters persist correctly across power cycles and reject out-of-range values with appropriate error messages.
Source: User need


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

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

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

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


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

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

"The GlucoTrack CGM fault tree analysis identifies root causes of potential software failures. Control measures include watchdog timers, redundant calculations, and plausibility checks on sensor data. Each measure is a traceable software requirement verified during system testing."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the GlucoTrack CGM (continuous glucose monitor display, Class B). Standards references are accurate.


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

[User]
Write a SDP section on requirements elicitation and documentation for LinacControl Beam Delivery System, a Class C Linear Accelerator Control Software. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Software controlling linear accelerator beam delivery during radiation therapy. Beam-on errors could deliver lethal radiation doses.

[Assistant] Content: The LinacControl Beam Delivery System software requirements are captured in the SRS per Clause 5.2.1. Sources include system requirements for the Linear Accelerator Control Software, risk control measures from the ISO 14971 analysis, and regulatory requirements from the target markets. Each requirement is verifiable and traceable.


[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 WaterPure Quality Logger, a Class A Water Quality Data Logger. Reference IEC 62304 Clause 5.7.4.
Embedded system logging purified water system parameters (conductivity, TOC, flow rate) for pharmaceutical manufacturing compliance.

[Assistant] Content: Coverage analysis for the WaterPure Quality Logger 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 Water Quality Data Logger release is contingent on 100% requirement coverage with no open gaps.


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

[User]
Write a SRS section on purpose of the SRS document for FactoryTemp Industrial Temperature Monitor, a Class A Industrial Temperature Monitoring Firmware. Reference IEC 62304 Clause 5.2.1.
Firmware monitoring factory floor temperatures from distributed thermocouple arrays. Logs data for process control compliance.

[Assistant] Content: This Software Requirements Specification defines the functional, performance, and interface requirements for the FactoryTemp Industrial Temperature Monitor Industrial Temperature Monitoring Firmware. Requirements are derived from system requirements, the risk management file, and stakeholder needs analysis per IEC 62304 Clause 5.2.1. Each requirement is uniquely identified, prioritized, and traceable to its source.


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

[User]
Write a FMEA section on failure mode identification approach for DreamLog Sleep Monitor, a Class A Sleep Tracking Display App. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

[Assistant] Content: The DreamLog Sleep Monitor failure mode identification per Clause 7.1.2 uses a function-by-function analysis of the Sleep Tracking Display App. Each software function is examined for potential failure modes: omission, commission, early, late, and value errors. Potential causes per Clause 7.1.2 include design defects, SOUP anomalies per Clause 7.1.3, and environmental factors.


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

[User]
Expand requirement SRS-FUNC-001: "data acquisition from primary sensor" (Category: functional)
Project: DoseCalc Medication Calculator | Medication Dose Calculator App | Class B
Calculating weight-based medication doses for clinical prescribing support. Mobile app calculating medication doses based on patient weight, age, and renal function. Incorrect calculations could cause underdosing or adverse effects.

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 DoseCalc Medication Calculator shall continuously sample primary sensor data, buffer readings in memory, and pass validated samples to the processing module without data loss.
Rationale: Reliable sensor data capture underpins all downstream processing and clinical output of the Medication Dose Calculator App.
Priority: Mandatory
Acceptance Criterion: Verified by test: software acquires sensor data continuously for 60 minutes without data loss, confirmed by comparing acquisition count against expected count at the configured sampling rate.
Source: System requirement


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

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

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

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


[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):

"Formal code inspections by independent reviewers are required for all ThermoGuard source code. Each module shall have unit tests with full branch coverage."

[Assistant]
Verdict: FAIL
Note: Content mandates independent code review and unit testing for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Independent review and unit testing are not required for Class A 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 SDP section on requirements verification approach for GrowthChart Pediatric Viewer, a Class A Growth Chart Display App. Reference IEC 62304 Clause 5.2.6.
Web app displaying pediatric growth charts with WHO/CDC percentile curves. Plots measurements, no diagnostic interpretation.

[Assistant] Content: Requirements verification for the GrowthChart Pediatric Viewer is conducted per Clause 5.2.6 before the requirements baseline is established. The review confirms completeness, consistency, and testability. Any requirement failing these criteria is returned for rework before the Growth Chart Display App proceeds to design.


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

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

"The lifecycle processes for the DermaScan AI comply with ISO 14901."

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

[User]
Write a SRS section on purpose of the SRS document for DermaLens Teledermatology Platform, a Class B Cloud Teledermatology SaMD. Reference IEC 62304 Clause 5.2.1.
Cloud platform enabling dermatologists to review patient-submitted skin images with AI-assisted triage scoring. Images uploaded from mobile app to cloud pipeline.

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


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

[User]
Write a SDP section on SOUP identification and management for ThermoWatch Core Temperature Monitor, a Class B Core Temperature Monitor Firmware. Reference IEC 62304 Clause 8.1.2.
Continuous core temperature monitoring firmware using an ingestible sensor pill. Displays temperature trend with configurable alerts.

[Assistant] Content: Identification of SOUP for the ThermoWatch Core Temperature Monitor follows Clause 8.1.2. Each SOUP component record includes title, version, supplier, intended function within the Core Temperature Monitor Firmware, and a reference to the anomaly evaluation performed per Clause 7.1.3. SOUP updates are managed through the change control process per Clause 8.2.


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

[User]
Write a SDP section on development tools and tool qualification for Class A for AutoHUD Heads-Up Display Controller, a Class A Automotive HUD Controller Firmware. Reference IEC 62304 Clause 5.1.4.
Firmware rendering vehicle speed, navigation, and ADAS warnings on a windshield-projected heads-up display.

[Assistant] Content: The AutoHUD Heads-Up Display Controller is developed in C (embedded, AUTOSAR) targeting the Qualcomm SA8155P platform. Source code is maintained under version control with branching and tagging conventions defined in SOP-012. For the Class A Automotive HUD Controller Firmware, formal tool qualification is not required per IEC 62304; however, the development toolchain is verified to function correctly through routine build-and-test cycles.


[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: "RAM and storage constraints" (Category: performance)
Project: FactoryTemp Industrial Temperature Monitor | Industrial Temperature Monitoring Firmware | Class A
Continuous monitoring and logging of factory floor temperatures for process control. Firmware monitoring factory floor temperatures from distributed thermocouple arrays. Logs data for process control compliance.

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

[Assistant]
Description: The FactoryTemp Industrial Temperature Monitor shall operate within the specified RAM and flash memory budget on the PLC (Allen-Bradley) platform, including all runtime allocations.
Rationale: Memory constraints are fixed by the PLC (Allen-Bradley) hardware and must be respected to prevent resource exhaustion during operation.
Priority: Mandatory
Acceptance Criterion: Memory profiling under stress conditions shows stable allocation with no leaks over a 72-hour test period.
Source: System requirement


[System] You are a regulatory 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):

"All deliverables undergo review by an independent technical reviewer not involved in development."

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


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

[User]
Write a SDP section on verification strategy for Class C -- unit, integration, and system with coverage for HomeVent BiPAP Controller, a Class C BiPAP Device Firmware. Reference IEC 62304 Clauses 5.5, 5.5.2, 5.6, 5.7.
Home bilevel positive airway pressure device firmware. Manages inspiratory/expiratory pressure, leak compensation, and patient triggering.

[Assistant] Content: Class C verification of the HomeVent BiPAP Controller requires unit testing with statement coverage of at least 90%, branch coverage of at least 80%, and MC/DC coverage of at least 80% for safety-critical modules. Integration testing per Clause 5.6 verifies all inter-unit interfaces including blower motor PWM, CPAP mask circuit. System-level verification per Clause 5.7 is performed by independent personnel not directly responsible for development.


[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 PowerTrack UPS Monitor, a Class A UPS Monitoring Software. Reference IEC 62304 Clause 5.2.2.
Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

[Assistant] Content: Computational resource requirements for the PowerTrack UPS Monitor define the maximum CPU utilization, RAM consumption, and flash/disk usage permitted on Linux server. The UPS Monitoring Software must meet all functional and timing requirements within these resource envelopes.


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

[User]
Write a SDP section on development tools and tool qualification for Class A for FleetTrack GPS Tracking Module, a Class A Fleet GPS Tracking Firmware. Reference IEC 62304 Clause 5.1.4.
Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

[Assistant] Content: The FleetTrack GPS Tracking Module development environment consists of C (embedded) targeting nRF9160 (LTE-M SiP), with version-controlled source and automated builds. Tool qualification per Clause 5.1.4 is not mandated for Class A software. Any tool defects affecting the Fleet GPS Tracking Firmware output are documented in the problem report system.


[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 PaceSet Pacemaker Programmer, a Class C Cardiac Pacemaker Programmer Software. Reference IEC 62304 Clause 5.1.1.
Desktop software for interrogating and programming cardiac pacemakers via telemetry wand. Incorrect programming could cause pacing failure.

[Assistant] Content: Milestones governing the PaceSet Pacemaker Programmer lifecycle include Requirements Baseline, Architecture Baseline, Implementation Complete, Verification Complete, and Release Readiness. Each milestone has defined entry and exit criteria documented in this plan. No milestone can be declared complete while open problem reports of severity "major" or higher remain unresolved.


[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 VibeCheck Vibration Analyzer, a Class A Vibration Analysis Instrument Firmware. Reference IEC 62304 Clause 5.2.2.
Portable vibration analysis firmware for predictive maintenance of industrial rotating machinery. FFT analysis of accelerometer data.

[Assistant] Content: The VibeCheck Vibration Analyzer communicates with external systems via LCD. Requirements specify authentication, data encryption, message integrity verification, and timeout handling. The Vibration Analysis Instrument Firmware must continue safe operation if the external system is unavailable.


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

[User] Is ISO 14901 a valid standard reference?

[Assistant] No. ISO 14901 does not exist as a medical device standard. The risk management standard is ISO 14971:2019.


[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 acquisition from primary sensor" (Category: functional)
Project: RoomBoard Digital Signage | Patient Room Digital Signage | Class A
Displaying non-clinical patient information on bedside screens. Hospital room digital signage displaying patient name, care team, and daily schedule. Display-only, no clinical data entry.

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 RoomBoard Digital Signage software shall acquire primary sensor data at the specified sampling rate and store values in a circular buffer for processing by the Patient Room Digital Signage signal pipeline.
Rationale: Reliable sensor data capture underpins all downstream processing and clinical output of the Patient Room Digital Signage.
Priority: Mandatory
Acceptance Criterion: System test confirms zero missed samples over a 24-hour continuous operation period at the maximum configured sampling rate.
Source: System requirement


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

[User]
Expand requirement SRS-SEC-002: "access control and authorization" (Category: security)
Project: AutoclaveLog Cycle Recorder | Sterilization Cycle Data Logger | Class A
Recording and reporting autoclave sterilization cycle parameters. PC software recording autoclave cycle data (time, temperature, pressure) and generating compliance reports.

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

[Assistant]
Description: User authentication shall be enforced for all configuration changes to the AutoclaveLog Cycle Recorder, with credential validation before granting access.
Rationale: Access control prevents unauthorized modification of the Sterilization Cycle Data Logger operating parameters.
Priority: Mandatory
Acceptance Criterion: Configuration modification is rejected when attempted without valid credentials, verified across all configurable parameters.
Source: Risk control


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

[User]
Write a SRS section on resource constraints and scalability for PaceSet Pacemaker Programmer, a Class C Cardiac Pacemaker Programmer Software. Reference IEC 62304 Clause 5.2.2.
Desktop software for interrogating and programming cardiac pacemakers via telemetry wand. Incorrect programming could cause pacing failure.

[Assistant] Content: The PaceSet Pacemaker Programmer resource constraints are derived from the Dedicated Windows tablet hardware capabilities. Requirements specify headroom margins for memory and processing to ensure the Cardiac Pacemaker Programmer Software remains stable under sustained operation during Programming and interrogating implanted cardiac pacemakers including rate settings, sensitivity, and output parameters.


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

[User]
Write a THREAT section on STRIDE mitigations traced to requirements for VitalPulse SpO2 Monitor, a Class B Pulse Oximeter Firmware. Reference IEC 62304 Clause 5.2.3.
Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

[Assistant] Content: Threat-to-mitigation traceability for the VitalPulse SpO2 Monitor Pulse Oximeter Firmware is maintained per Clause 5.2.3. Each STRIDE threat is mapped to a security requirement, an implementation, and a verification test. This traceability ensures no identified threat lacks a corresponding software control.


[System] You are a regulatory 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):

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

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


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

[User]
Expand requirement SRS-SAFE-002: "safe state transition on critical failure" (Category: safety)
Project: NeuroTune DBS Programmer | Deep Brain Stimulator Programmer App | Class C
Programming stimulation parameters of implanted deep brain stimulators for Parkinson's disease management. Tablet application programming deep brain stimulation implants for movement disorders. Stimulation parameter errors could cause neurological harm.

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

[Assistant]
Description: A deterministic safe-state transition shall be triggered by any detected critical fault condition in the NeuroTune DBS Programmer, with all active outputs brought to a known safe configuration.
Rationale: Fail-safe behavior is essential to prevent the Deep Brain Stimulator Programmer App from causing harm when its software detects an unrecoverable error.
Priority: Mandatory
Acceptance Criterion: Safe state transition completes within the specified time limit for each defined critical fault, verified by fault injection during operation.
Source: Risk control


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

[User]
Expand requirement SRS-PERF-003: "computational accuracy requirement" (Category: performance)
Project: PharmaSafe CDSS | Clinical Decision Support System | Class B
Real-time clinical decision support for medication safety including interaction checking and dose validation. Clinical decision support system integrated into hospital EMR providing real-time drug-drug interaction alerts, allergy checking, and dosing guidance.

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

[Assistant]
Description: Output accuracy of the Clinical Decision Support System shall meet or exceed the specified tolerance for all measurement parameters across operating conditions.
Rationale: Measurement accuracy directly affects clinical decisions based on the Clinical Decision Support System output and is a key factor in the risk profile.
Priority: Mandatory
Acceptance Criterion: Statistical analysis of 500 measurements shows mean error within tolerance and standard deviation within specified limits.
Source: Regulatory