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

[User]
Expand requirement SRS-PERF-001: "computational accuracy requirement" (Category: performance)
Project: RespiRate Respiratory Monitor | Respiratory Rate Monitor Firmware | Class B
Continuous respiratory rate monitoring with alarm generation for abnormal rates. Wearable firmware monitoring respiratory rate via chest impedance. Displays rate and alerts on bradypnea/tachypnea.

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


[System] You are 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 intracardiac impedance" (Category: functional)
Project: CardioLoop Cardiac Resync Controller | CRT Optimization Firmware | Class C
Real-time optimization of biventricular pacing parameters based on hemodynamic sensor feedback. Firmware for cardiac resynchronization therapy devices optimizing biventricular pacing based on hemodynamic feedback.

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 CardioLoop Cardiac Resync Controller software shall acquire intracardiac impedance data at the specified sampling rate and store values in a circular buffer for processing by the CRT Optimization Firmware signal pipeline.
Rationale: Continuous data acquisition from the primary sensor is the fundamental input for Real-time optimization of biventricular pacing parameters based on hemodynamic sensor feedback.
Priority: Mandatory
Acceptance Criterion: System test confirms zero missed samples over a 24-hour continuous operation period at the maximum configured sampling rate.
Source: System requirement


[System] You are a regulatory 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 PhysioTrack Rehabilitation Monitor, a Class B Physical Therapy Tracking System. Reference IEC 62304 Clause 5.2.6.
Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

[Assistant] Content: Requirements verification for the PhysioTrack Rehabilitation Monitor 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 Physical Therapy Tracking System proceeds to design.


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

[User]
Write a SDP section on development methodology for Class B for RemotICU Continuous Monitoring Hub, a Class B Edge-to-Cloud ICU Monitoring Gateway. Reference IEC 62304 Clause 5.1.1.
Edge gateway collecting data from bedside monitors (SpO2, HR, BP, ventilator) and streaming to cloud for trending, alerting, and tele-ICU review.

[Assistant] Content: The RemotICU Continuous Monitoring Hub follows a V-model lifecycle with iterative refinement, as the Class B classification requires architectural verification and integration testing that map naturally to the V-model's verification branches. Phase gates are established at Requirements Baseline, Architecture Review, Integration Test Complete, and System Test Complete, each requiring documented evidence before proceeding.


[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):

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

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


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

[User]
Expand requirement SRS-PERF-001: "RAM and storage constraints" (Category: performance)
Project: MedImage PACS Viewer | Web PACS Image Viewer | Class A
Web-based display and annotation of DICOM medical images for radiologist review. Web-based PACS viewer enabling radiologists to review DICOM images with standard tools (windowing, measurement, MPR). View-only, no AI or diagnostic processing.

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 MedImage PACS Viewer memory footprint on Cloud CDN + DICOMweb server shall remain within specified limits under worst-case operational scenarios.
Rationale: Memory constraints are fixed by the Cloud CDN + DICOMweb server 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 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] What clause numbers exist under IEC 62304 Clause 4?

[Assistant]
IEC 62304 Clause 4 contains exactly three sub-clauses:

- Clause 4.1: Quality management system
- Clause 4.2: Risk management
- Clause 4.3: Software safety classification

There are no sub-clauses 4.4 or higher.


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

[User]
Write a SDP section on change control and trend analysis for problems for PulmoCheck Spirometry Analyzer, a Class B Spirometry Analysis Software. Reference IEC 62304 Clauses 9.4, 9.6.
Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

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


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

[User]
Write a THREAT section on STRIDE threat categories applied to the device for ECGInsight Rhythm Interpreter, a Class B ECG Interpretation Service. Reference IEC 62304 Clause 5.2.2.
Cloud service analyzing 12-lead ECG recordings and generating preliminary rhythm interpretations for physician review.

[Assistant] Content: Threats to the ECGInsight Rhythm Interpreter are categorized using the STRIDE framework: Spoofing of DICOM ECG input identity, Tampering with sensor data or configuration, Repudiation of clinical actions, Information Disclosure of patient data, Denial of Service disrupting Automated preliminary interpretation of 12-lead ECG recordings for physician review and overread, and Elevation of Privilege through unauthorized parameter changes.


[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 B -- integration and system testing for PressoTrack Blood Pressure Trending, a Class B Ambulatory Blood Pressure Monitor Firmware. Reference IEC 62304 Clauses 5.6, 5.6.3, 5.7.
Firmware for an automated blood pressure cuff that trends readings over 24 hours. Trending errors could mask hypertensive episodes.

[Assistant] Content: Integration and system testing constitute the mandatory verification activities for the PressoTrack Blood Pressure Trending Ambulatory Blood Pressure Monitor Firmware at Class B. Integration tests per Clause 5.6 verify data exchange across architectural boundaries, while system tests per Clause 5.7 exercise the complete software against the SRS. Unit testing may be applied to selected modules but is not required.


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

[User]
Write a SDP section on change control process for NutriCalc TPN Formulation Tool, a Class B TPN Formulation Calculator. Reference IEC 62304 Clauses 8.2, 8.2.1.
Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

[Assistant] Content: No change to the NutriCalc TPN Formulation Tool 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 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 ScreenFlow Population Health Screener, a Class A Serverless Population Health Screening SaMD. Reference IEC 62304 Clause 5.2.2.
Serverless cloud application processing population-level health screening questionnaires and flagging individuals for follow-up based on risk scoring algorithms.

[Assistant] Content: Computational resource requirements for the ScreenFlow Population Health Screener define the maximum CPU utilization, RAM consumption, and flash/disk usage permitted on AWS Lambda + DynamoDB + API Gateway. The Serverless Population Health Screening SaMD must meet all functional and timing requirements within these resource envelopes.


[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 BSACalc Body Surface Area Tool, a Class B BSA Calculator Web App. Reference IEC 62304 Clause 5.7.4.
Web calculator for body surface area using Mosteller and DuBois formulas. Used for chemotherapy dose calculations.

[Assistant] Content: The BSACalc Body Surface Area Tool traceability gap analysis identifies three types of gaps: unverified requirements, orphaned implementations, and unlinked test cases. Each gap is documented with a resolution plan and tracked to closure. Clause 5.7.4 verification of the BSA Calculator Web App system test is not complete until all gaps are resolved.


[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):

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

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


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

[User]
Write a SDP section on hazard identification for the specific device for WasteTrack Biohazard Logger, a Class A Biohazard Waste Tracking App. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Mobile app scanning and logging biohazard waste container pickups. Tracks chain of custody for environmental compliance.

[Assistant] Content: Software-related hazard causes for the WasteTrack Biohazard Logger Biohazard Waste Tracking App are documented per Clause 7.1.2 and Clause 7.1.4. Risk control measures per Clause 7.2.1 address each identified cause through input validation, range checking, communication integrity verification, and fail-safe defaults.


[System] You are 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-004: "alarm generation and notification" (Category: functional)
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: The Skin Lesion Classification App shall monitor all active parameters against user-configured thresholds and activate appropriate alarm signals when limits are breached.
Rationale: Timely alarm generation is essential for the Skin Lesion Classification App to alert clinicians to abnormal conditions requiring intervention.
Priority: Mandatory
Acceptance Criterion: No alarm condition goes undetected across 200 simulated threshold exceedances with varying parameter values and crossing rates.
Source: Risk control


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

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

"The OxyPure Controller development follows ISO 62304 for the software lifecycle."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 62304" which is incorrect. Wrong prefix. The correct standard is IEC 62304, not ISO 62304. All references must be corrected.


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

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

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

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


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

[User]
Expand requirement SRS-FUNC-006: "measurement data archival" (Category: functional)
Project: AssetTrack Equipment Inventory | Equipment Inventory System | Class A
Tracking location and status of medical equipment for inventory management. Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management only.

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

[Assistant]
Description: The Equipment Inventory System shall maintain a timestamped record of all measurements in non-volatile storage, supporting export via REST API.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Equipment Inventory System.
Priority: Desirable
Acceptance Criterion: Logged data is retrievable after power cycle, with all timestamps accurate to within 1 second of the reference clock.
Source: User need


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

[User]
Write a SDP section on problem reporting and investigation for BreathSync ICU Ventilator Controller, a Class C ICU Ventilator Controller Software. Reference IEC 62304 Clauses 9.1, 9.2.
Software controlling an ICU mechanical ventilator with multiple ventilation modes (volume, pressure, SIMV). Failure could result in patient death.

[Assistant] Content: Problems identified in the BreathSync ICU Ventilator Controller are reported per Clause 9.1 with anomaly description, affected component, severity, and reproduction steps. Investigation per Clause 9.2 determines root cause and impact. Relevant parties are advised per Clause 9.3 when the problem affects the ICU Ventilator Controller Software safety or regulatory compliance.


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

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

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

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


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

[User]
Write a SAD section on error propagation and data integrity in the pipeline for HomeVent BiPAP Controller, a Class C BiPAP Device Firmware. Reference IEC 62304 Clause 5.3.2.
Home bilevel positive airway pressure device firmware. Manages inspiratory/expiratory pressure, leak compensation, and patient triggering.

[Assistant] Content: The HomeVent BiPAP Controller architecture prevents error propagation by requiring input validation at every software item boundary per Clause 5.3.2. When a software item detects invalid input, it transitions to a defined error state and notifies the error management subsystem. The BiPAP Device Firmware maintains safe operation during error recovery.


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

[User]
Expand requirement SRS-SEC-001: "access control and authorization" (Category: security)
Project: DoseVerify In-Vivo Dosimetry System | In-Vivo Dosimetry Verification Software | Class C
Real-time verification of delivered radiation dose using in-vivo dosimeter measurements during treatment. Software calculating real-time delivered dose from in-vivo dosimeter readings during radiation therapy. Dose verification for patient safety.

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

[Assistant]
Description: User authentication shall be enforced for all configuration changes to the DoseVerify In-Vivo Dosimetry System, with credential validation before granting access.
Rationale: Unauthorized configuration changes to the In-Vivo Dosimetry Verification Software could compromise its intended function or patient safety.
Priority: Mandatory
Acceptance Criterion: Configuration modification is rejected when attempted without valid credentials, verified across all configurable parameters.
Source: Risk control


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

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

"Compliance with IEC 62304 Clause 5.7.6 (security testing) and Clause 11.1 (user acceptance testing) is demonstrated."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.7.6 and 11.1, neither of which exists. Clause 5.7 has 5.7.1 through 5.7.5 only. IEC 62304 has no Clause 11. All clause references must be corrected.


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

[User]
Expand requirement SRS-FUNC-003: "display update rate for Growth Chart Display App" (Category: functional)
Project: GrowthChart Pediatric Viewer | Growth Chart Display App | Class A
Visual display of pediatric growth measurements on standard percentile charts. Web app displaying pediatric growth charts with WHO/CDC percentile curves. Plots measurements, no diagnostic 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: Output presentation on the FHIR Observation API shall refresh at the configured interval, reflecting the most recent processed data from the Growth Chart Display App pipeline.
Rationale: Timely display updates ensure the user observes current readings without perceiving lag.
Priority: Mandatory
Acceptance Criterion: End-to-end latency from data acquisition to display update does not exceed the specified limit for 99.9% of samples.
Source: User need


[System] You are 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 5.8.9 requires the DialysisGuard to implement data archival."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.8.9 which does not exist. Clause 5.8 has 5.8.1 through 5.8.8 only. The reference must be corrected to a valid clause number.


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

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

"IEC 62311-1 Section 5.3 requires all software units to be verified."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62311-1" which is incorrect. IEC 62311 covers EMF exposure limits, not medical device software. All references must be corrected.


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

[User]
Write a SDP section on development platform and build infrastructure for AquaGuard Water Quality Monitor, a Class A Water Quality Monitoring Firmware. Reference IEC 62304 Clause 5.1.4.
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 build environment uses C (embedded) on MSP430FR (ultra-low-power). Continuous integration builds execute on every commit, ensuring early detection of compilation errors and regression failures. Toolchain versions are locked to the configuration baseline and recorded in the Software Configuration Management Plan.


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

[User]
Expand requirement SRS-INTF-002: "sensor data link requirements" (Category: interface)
Project: HandGrip Strength Dynamometer | Hand Dynamometer Firmware | Class B
Measuring hand grip strength and fatigue patterns for rehabilitation progress tracking. Digital hand dynamometer firmware measuring grip strength and fatigue over repeated trials for rehabilitation assessment.

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 HandGrip Strength Dynamometer shall communicate with the strain gauge load cell via BLE 5.0, implementing error detection and recovery for communication failures.
Rationale: Reliable sensor communication is the foundation of the Hand Dynamometer Firmware data acquisition pipeline.
Priority: Mandatory
Acceptance Criterion: Communication operates without data loss for 72 hours continuously, with automatic recovery from simulated failures within the specified time.
Source: System requirement


[System] You are 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 minimal deliverables list for Class A for SunGuard UV Index Display, a Class A UV Exposure Display Firmware. Reference IEC 62304 Clause 5.1.8.
Wearable UV index monitor with an OLED display showing current UV exposure level. Informational only, no sunburn prevention claims.

[Assistant] Content: The SunGuard UV Index Display Class A documentation plan produces five controlled documents: this SDP, the Software Requirements Specification, the System Test Plan and Report, the Software Release Record, and the Risk Management File. No additional verification documents are required for the UV Exposure Display Firmware.


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

[User]
Write a SDP section on safety classification process and documentation for AuditTrail QMS Event Logger, a Class A QMS Audit Trail Service. Reference IEC 62304 Clause 4.3.
Microservice capturing and storing quality management system audit events. Logging and reporting only.

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


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

[User]
Write a SDP section on safety classification process and documentation for HeartView Resting HR Display, a Class A Heart Rate Display Firmware. Reference IEC 62304 Clause 4.3.
Wearable firmware that shows resting heart rate on a small OLED screen. Read-only display with no arrhythmia detection or clinical alerts.

[Assistant] Content: The safety classification of the HeartView Resting HR Display was determined per IEC 62304 Clause 4.3, considering the software's contribution to hazardous situations identified in the ISO 14971 risk analysis. The classification is documented in the risk management file and reviewed whenever the intended use, system architecture, or risk profile of the Heart Rate Display Firmware changes.


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

[User]
Expand requirement SRS-INTF-001: "clinical system integration interface" (Category: interface)
Project: AnesBot Automated Anesthesia Controller | Automated Anesthesia Delivery Software | Class C
Target-controlled propofol infusion guided by processed EEG depth-of-anesthesia monitoring. Software controlling target-controlled infusion of propofol based on BIS monitoring. Overdose could cause respiratory arrest.

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 AnesBot Automated Anesthesia Controller shall exchange data with external systems via serial to BIS monitor using the specified message format with error handling.
Rationale: External system connectivity is required for the Automated Anesthesia Delivery Software to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


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

[User]
Review this documentation excerpt for the VentAssist Pro (ICU ventilator controller, Class C):

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

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


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

[User]
Expand requirement SRS-INTF-001: "data export and interoperability" (Category: interface)
Project: WasteTrack Biohazard Logger | Biohazard Waste Tracking App | Class A
Logging and tracking biohazard waste container chain of custody. Mobile app scanning and logging biohazard waste container pickups. Tracks chain of custody for environmental compliance.

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

[Assistant]
Description: The Biohazard Waste Tracking App shall support bidirectional data exchange with external systems over REST API.
Rationale: External system connectivity is required for the Biohazard Waste Tracking App to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


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

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

"Each CaloriePal module shall have a traceability matrix linking detailed design elements to unit test cases with full coverage."

[Assistant]
Verdict: FAIL
Note: Content mandates detailed design traceability to unit tests for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Detailed design (Clause 5.4) and unit verification (Clause 5.5) are not required for Class A.


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

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

[Assistant] Content: Interface requirements for the SupplyChain Procurement Portal specify the communication protocols, data formats, and timing constraints for each external interface of the Supply Chain Procurement System. The primary data acquisition interface uses REST API with specified data rates and error detection mechanisms.


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

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

"REQ-SRS-012: The PhysioTrack Rehab shall log all user actions with timestamps in an audit trail stored in non-volatile memory. The audit trail shall retain at least 10,000 entries. Acceptance criterion: verify log persistence across power cycles and entry count capacity. Priority: Mandatory. Source: Regulatory."

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


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

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

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

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


[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 primary international standards applicable to development for HandGrip Strength Dynamometer, a Class B Hand Dynamometer Firmware. Reference IEC 62304 Clause 5.1.2.
Digital hand dynamometer firmware measuring grip strength and fatigue over repeated trials for rehabilitation assessment.

[Assistant] Content: Development of the HandGrip Strength Dynamometer software conforms to IEC 62304:2006+AMD1:2015 for the software lifecycle and ISO 14971:2019 for risk management integration. Quality management activities follow ISO 13485:2016, while usability engineering principles from IEC 62366-1:2015+AMD1:2020 inform the user interface design of the Hand Dynamometer Firmware.


[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 HeartView Resting HR Display, a Class A Heart Rate Display Firmware. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Wearable firmware that shows resting heart rate on a small OLED screen. Read-only display with no arrhythmia detection or clinical alerts.

[Assistant] Content: The HeartView Resting HR Display risk controls per Clause 7.2.1 address each failure mode with unacceptable residual risk. Software-implemented controls per Clause 7.2.2 include defensive coding measures, plausibility checks, and safe-state transitions. Each control is documented as a software requirement and verified for the Heart Rate Display Firmware.


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

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

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

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


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

[User]
Expand requirement SRS-INTF-001: "sensor data link requirements" (Category: interface)
Project: CardioRhythm ECG Analyzer | Single-Lead ECG Device Firmware | Class B
Acquisition and preliminary rhythm classification of single-lead ECG for clinical screening. Portable ECG device firmware acquiring single-lead ECG and classifying basic rhythm types. Incorrect classification could delay diagnosis.

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

[Assistant]
Description: Communication with the ADS1292R ECG AFE over SPI shall include CRC-based error detection, automatic retry, and graceful degradation on persistent failure.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Single-Lead ECG Device Firmware output.
Priority: Mandatory
Acceptance Criterion: Communication operates without data loss for 72 hours continuously, with automatic recovery from simulated failures within the specified time.
Source: System requirement


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

[User]
Expand requirement SRS-PERF-001: "end-to-end processing latency" (Category: performance)
Project: AssetTrack Equipment Inventory | Equipment Inventory System | Class A
Tracking location and status of medical equipment for inventory management. Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management only.

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

[Assistant]
Description: The AssetTrack Equipment Inventory shall process acquired data and update the output within the specified end-to-end latency from sample acquisition to display update.
Rationale: Bounded processing latency ensures the Equipment Inventory System provides readings reflecting the current state without clinically significant delay.
Priority: Mandatory
Acceptance Criterion: End-to-end latency is within the specified limit for 99.9% of samples over a 24-hour test period.
Source: System requirement


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

[User]
Write a SRS section on data retention and integrity requirements for PharmaSafe CDSS, a Class B Clinical Decision Support System. Reference IEC 62304 Clause 5.2.2.
Clinical decision support system integrated into hospital EMR providing real-time drug-drug interaction alerts, allergy checking, and dosing guidance.

[Assistant] Content: Persistent data managed by the PharmaSafe CDSS includes configuration parameters, acquired measurements from data sources, and operational logs. Data integrity requirements specify error detection mechanisms and the Clinical Decision Support System response to data corruption events.


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

[User]
Expand requirement SRS-INTF-001: "intracardiac impedance communication specification" (Category: interface)
Project: CardioLoop Cardiac Resync Controller | CRT Optimization Firmware | Class C
Real-time optimization of biventricular pacing parameters based on hemodynamic sensor feedback. Firmware for cardiac resynchronization therapy devices optimizing biventricular pacing based on hemodynamic feedback.

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 CardioLoop Cardiac Resync Controller shall communicate with the intracardiac impedance via RF telemetry, implementing error detection and recovery for communication failures.
Rationale: Reliable sensor communication is the foundation of the CRT Optimization Firmware data acquisition pipeline.
Priority: Mandatory
Acceptance Criterion: Error injection tests confirm 100% detection rate for corrupted frames and recovery within specified timeout.
Source: System requirement


[System] You are a regulatory 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):

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

[User]
Expand requirement SRS-FUNC-002: "real-time data presentation on HL7 FHIR to hospital EMR" (Category: functional)
Project: TriagePro Emergency Scoring App | Emergency Department Triage SaMD | Class B
Guiding emergency department triage scoring using the Manchester Triage System protocol. Standalone tablet app implementing Manchester Triage System scoring. Guides clinicians through triage flowchart and records patient acuity level.

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 TriagePro Emergency Scoring App shall update the displayed values on the HL7 FHIR to hospital EMR at intervals no greater than the specified refresh period.
Rationale: Timely display updates ensure the user observes current readings without perceiving lag.
Priority: Mandatory
Acceptance Criterion: End-to-end latency from data acquisition to display update does not exceed the specified limit for 99.9% of samples.
Source: User need


[System] You are 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 NeuroStim Programmer (neurostimulator programmer, Class C):

"Verification activities follow IEC 62304 Clause 10.1 for data archival."

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

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

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

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


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

[User]
Write a SRS section on data retention and integrity requirements for WasteTrack Biohazard Logger, a Class A Biohazard Waste Tracking App. Reference IEC 62304 Clause 5.2.2.
Mobile app scanning and logging biohazard waste container pickups. Tracks chain of custody for environmental compliance.

[Assistant] Content: Persistent data managed by the WasteTrack Biohazard Logger includes configuration parameters, acquired measurements from camera barcode scanner, and operational logs. Data integrity requirements specify error detection mechanisms and the Biohazard Waste Tracking App response to data corruption events.


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

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

"The HydroLog test plan covers system-level tests only. Each requirement in the SRS maps to one or more system test cases. No unit or integration testing is planned for this Class A hydration tracking wellness app. Test execution is documented per Clause 5.7.5."

[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-FUNC-006: "continuous data sampling from primary sensor" (Category: functional)
Project: ClinTrial EDC Platform | Clinical Trial EDC Web Platform | Class A
Electronic capture and management of clinical trial data across multiple investigator sites. Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

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 ClinTrial EDC Platform software shall acquire primary sensor data at the specified sampling rate and store values in a circular buffer for processing by the Clinical Trial EDC Web Platform signal pipeline.
Rationale: Continuous data acquisition from the primary sensor is the fundamental input for Electronic capture and management of clinical trial data across multiple investigator sites.
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 an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on cybersecurity and health IT standards for AutoPancreas Closed-Loop Glucose Controller, a Class C Artificial Pancreas Controller Firmware. Reference IEC 62304 Clause 5.1.2.
Artificial pancreas firmware integrating CGM readings with insulin pump delivery using a PID control algorithm. Life-sustaining closed-loop system.

[Assistant] Content: The AutoPancreas Closed-Loop Glucose Controller cybersecurity posture is defined per IEC 81001-5-1:2021, covering threat modeling, secure design, vulnerability management, and incident response for the Artificial Pancreas Controller Firmware. Health software product safety requirements from IEC 82304-1:2016 supplement the IEC 62304 lifecycle where applicable.


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

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

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

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


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

[User]
Write a SDP section on problem reporting and investigation for SunGuard UV Index Display, a Class A UV Exposure Display Firmware. Reference IEC 62304 Clauses 9.1, 9.2.
Wearable UV index monitor with an OLED display showing current UV exposure level. Informational only, no sunburn prevention claims.

[Assistant] Content: Software problems discovered during SunGuard UV Index Display development are documented as problem reports per Clause 9.1, including a description of the anomaly, steps to reproduce, and the affected configuration item. Investigation per Clause 9.2 determines the root cause, assesses the impact on previously verified items, and identifies whether the problem affects the safety or effectiveness of the UV Exposure Display Firmware.


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

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

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

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


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

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

"The SleepWell addresses IEC 62304 Clause 5.7.6 (detailed design verification) through formal review."

[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 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):

"IEC 62304 Clause 5.8.9 requires the DermaScan AI to implement performance benchmarking."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.8.9 which does not exist. Clause 5.8 has 5.8.1 through 5.8.8 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-INTF-001: "external system data exchange" (Category: interface)
Project: SeismicWatch Earthquake Early Warning | Seismic Early Warning Firmware | Class A
Detecting seismic P-waves and providing early warning of potentially damaging earthquakes. Firmware for a network of MEMS accelerometers providing earthquake early warning by detecting P-waves and estimating magnitude.

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

[Assistant]
Description: Data interoperability with clinical information systems shall be provided through Ethernet, supporting standard message formats.
Rationale: Interoperability enables integration of Seismic Early Warning Firmware data into the clinical workflow and patient record.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


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

[User]
Write a SRS section on system boundaries and external dependencies for LinacControl Beam Delivery System, a Class C Linear Accelerator Control Software. Reference IEC 62304 Clause 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 system overview identifies all external entities interacting with the Linear Accelerator Control Software: input sources (ionization chamber (x2)), output destinations (operator console), and the VxWorks RTOS on PowerPC execution environment. Requirements for each external interface are documented in the interface requirements section.


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

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

"Software safety classification is performed per IEC 62304:2015 Clause 4.3."

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


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

[User]
Review this documentation excerpt for the VentAssist Pro (ICU ventilator controller, Class C):

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

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


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

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

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

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


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

[User]
Write a SDP section on development tools and tool qualification for Class A for ConsentView Informed Consent Archive, a Class A Consent Document Viewer. Reference IEC 62304 Clause 5.1.4.
Web portal for patients and staff to view signed informed consent documents. Read-only document viewer.

[Assistant] Content: The ConsentView Informed Consent Archive is developed in TypeScript/React targeting the Web SPA platform. Source code is maintained under version control with branching and tagging conventions defined in SOP-012. For the Class A Consent Document Viewer, 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. Generate precise, class-appropriate content for medical device software documentation.

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

[Assistant] Content: Processing requirements for the DermaLens Teledermatology Platform Cloud Teledermatology SaMD cover data acquisition, filtering, computation, and presentation. Each processing step has specified input ranges, output tolerances, and error conditions. Data integrity is maintained throughout the processing pipeline.


[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 SeismicWatch Earthquake Early Warning, a Class A Seismic Early Warning Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware for a network of MEMS accelerometers providing earthquake early warning by detecting P-waves and estimating magnitude.

[Assistant] Content: The SeismicWatch Earthquake Early Warning communicates with external systems via alarm relay. Requirements specify authentication, data encryption, message integrity verification, and timeout handling. The Seismic Early Warning Firmware must continue safe operation if the external system is unavailable.


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

[User]
Write a SDP section on internal SOPs and procedures for RoomBoard Digital Signage, a Class A Patient Room Digital Signage. Reference IEC 62304 Clause 5.1.2.
Hospital room digital signage displaying patient name, care team, and daily schedule. Display-only, no clinical data entry.

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


[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):

"Class C verification for the InfuSafe Controller includes 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 verifies all inter-unit interfaces. System-level verification is performed by independent personnel."

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


[System] You are a regulatory 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):

"Verification activities follow IEC 62304 Clause 7.5 for automated regression testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 7.5 which does not exist. Clause 7 ends at 7.4. The reference must be corrected to a valid clause number.


[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 primary international standards applicable to development for PulseRing Smart Ring Monitor, a Class B Wearable Smart Ring Firmware + Companion App. Reference IEC 62304 Clause 5.1.2.
Wearable smart ring firmware measuring continuous PPG for heart rate and SpO2 with BLE streaming to companion mobile app for trend display.

[Assistant] Content: The software lifecycle for the PulseRing Smart Ring Monitor is executed under IEC 62304:2006+AMD1:2015, with risk management per ISO 14971:2019 integrated at each phase gate. Quality system requirements follow ISO 13485:2016, and usability validation of the Wearable Smart Ring Firmware + Companion App follows IEC 62366-1:2015+AMD1:2020.


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

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

"All verification for the surgical navigation system follows ISO 13485-1 requirements."

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

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

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

[Assistant]
Description: The PulmoCheck Spirometry Analyzer shall generate audible and visual alarms within the specified response time when a monitored parameter exceeds its configured threshold.
Rationale: Timely alarm generation is essential for the Spirometry Analysis Software to alert clinicians to abnormal conditions requiring intervention.
Priority: Mandatory
Acceptance Criterion: Alarm triggers within the specified response time of a threshold crossing, measured over 50 test crossings with no false negatives.
Source: Risk control


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

[User]
Write a SDP section on safety classification process and documentation for RoomBoard Digital Signage, a Class A Patient Room Digital Signage. Reference IEC 62304 Clause 4.3.
Hospital room digital signage displaying patient name, care team, and daily schedule. Display-only, no clinical data entry.

[Assistant] Content: Clause 4.3 of IEC 62304 requires classification of the RoomBoard Digital Signage based on the severity of harm that could result from software malfunction. The classification was performed in conjunction with the ISO 14971 risk analysis for the Patient Room Digital Signage and is subject to re-evaluation if the intended use or risk profile changes per Clause 5.2.4.


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

[User]
Write a SDP section on configuration identification approach for OBDView Diagnostic Display, a Class A Vehicle Diagnostic Display App. Reference IEC 62304 Clauses 8.1, 8.1.1.
Mobile app connecting to vehicle OBD-II port to display engine parameters, fault codes, and emissions data.

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


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

[User]
Write a SDP section on hazard identification for the specific device for LinacControl Beam Delivery System, a Class C Linear Accelerator Control Software. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Software controlling linear accelerator beam delivery during radiation therapy. Beam-on errors could deliver lethal radiation doses.

[Assistant] Content: Hazard identification for the LinacControl Beam Delivery System per Clause 7.1.2 considers all software functions that could contribute to patient harm. Identified causes include incorrect ionization chamber (x2) processing, loss of communication on real-time fieldbus, and failure to detect out-of-range conditions during Controlling radiation beam delivery including gantry position, collimator settings, and dose monitoring.


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

[User]
Write a SRS section on data retention and integrity requirements for NutriCalc TPN Formulation Tool, a Class B TPN Formulation Calculator. Reference IEC 62304 Clause 5.2.2.
Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

[Assistant] Content: The NutriCalc TPN Formulation Tool TPN Formulation Calculator data requirements address storage, integrity, and lifecycle management. All persistent data is validated on read, and write operations use atomic commit mechanisms to prevent partial updates during Calculating TPN component concentrations and volumes based on nutritional requirements.


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

[User]
Expand requirement SRS-FUNC-003: "display update rate for Cognitive Assessment Application" (Category: functional)
Project: CogniTest Cognitive Assessment App | Cognitive Assessment Application | Class B
Administering and scoring standardized cognitive screening tests for clinical neuropsychological assessment. Tablet app administering standardized cognitive screening tests and scoring results. Used by neuropsychologists in clinical settings.

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

[Assistant]
Description: Output presentation on the local database shall refresh at the configured interval, reflecting the most recent processed data from the Cognitive Assessment Application pipeline.
Rationale: Display freshness is critical for the Cognitive Assessment Application to provide actionable information to the user.
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 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 DialyFlow Dialysis Fluid Controller, a Class C Hemodialysis Fluid Controller Firmware. Reference IEC 62304 Clause 5.2.3.
Firmware controlling dialysate flow rates and composition in a hemodialysis machine. Fluid balance errors could be fatal.

[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 DialyFlow Dialysis Fluid Controller, this includes controls addressing conductivity sensors (x2) failure modes, communication integrity on CAN bus, and data validation.


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

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

"The CardioPulse Monitor addresses IEC 62304 Clause 6.4 for performance benchmarking and Clause 4.5 for deployment validation."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 6.4 and 4.5, neither of which exists. Clause 6 has 6.1, 6.2, 6.3 only. Clause 4 only has 4.1, 4.2, 4.3. All clause references must be corrected.


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

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

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

[Assistant]
Description: The NeoFeed Neonatal Feeding Pump shall exchange data with external systems via stepper motor driver using the specified message format with error handling.
Rationale: External system connectivity is required for the Neonatal Feeding Pump Firmware to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


[System] You are 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):

"Problem resolution for the AutoDose TPN follows Clause 9. Problem reports capture severity, affected version, and steps to reproduce (Clause 9.1). Investigation per Clause 9.2 determines root cause. Trends are analyzed per Clause 9.6 at each milestone review."

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


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

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

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

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


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

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

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

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


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

[User]
Write a SRS section on sensor and communication protocol 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: Interface requirements for the VibeCheck Vibration Analyzer specify the communication protocols, data formats, and timing constraints for each external interface of the Vibration Analysis Instrument Firmware. The primary data acquisition interface uses BNC input with specified data rates and error detection mechanisms.


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

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

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

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


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

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

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

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


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

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

"Compliance with IEC 62304 Clause 5.0 is demonstrated through performance benchmarking."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.0 which does not exist. Clause 5 starts at 5.1. The reference must be corrected to a valid clause number.


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

[User]
Write a SDP section on hazard identification for the specific device for SurgLog Procedure Documentation App, a Class A Surgical Documentation App. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

[Assistant] Content: Software-related hazard causes for the SurgLog Procedure Documentation App Surgical Documentation App are documented per Clause 7.1.2 and Clause 7.1.4. Risk control measures per Clause 7.2.1 address each identified cause through input validation, range checking, communication integrity verification, and fail-safe defaults.


[System] You are 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 CalibrationTracker Equipment Logger, a Class A Calibration Record System. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Web application tracking calibration dates and results for medical test equipment. Administrative record keeping.

[Assistant] Content: Software requirements for the CalibrationTracker Equipment Logger are derived from system requirements, the risk management file, and stakeholder inputs per Clause 5.2.1. Each requirement specifies functional behavior, performance criteria, or interface constraints relevant to the Calibration Record System and its use in Tracking calibration schedules and recording calibration results for compliance.


[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 SOUP risk evaluation examines published anomaly lists per Clause 7.1.3. Known anomalies in third-party libraries are assessed for potential contribution to hazardous situations. Mitigations include version pinning, input validation, and fallback behavior when SOUP components fail."

[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-004: "configuration persistence and validation" (Category: functional)
Project: PainRelief PCA Pump Controller | PCA Pump Controller Firmware | Class C
Patient-controlled analgesic delivery with lockout intervals and cumulative dose limits. Patient-controlled analgesia pump firmware allowing patient-initiated doses within physician-set limits. Overdose prevention is safety-critical.

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

[Assistant]
Description: Operating parameters of the PCA Pump Controller Firmware shall be user-configurable within validated ranges and stored in non-volatile memory.
Rationale: Parameter flexibility is essential for the PCA Pump Controller Firmware to meet varying clinical requirements across deployment sites.
Priority: Mandatory
Acceptance Criterion: All configurable parameters persist correctly across power cycles and reject out-of-range values with appropriate error messages.
Source: User need


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

[User]
Write a TRACE section on purpose and scope of the traceability matrix for MedRef Clinical Reference App, a Class A Clinical Drug Reference App. Reference IEC 62304 Clause 5.7.1.
Standalone mobile app providing searchable drug reference database with interaction checker. Display-only — no prescription or dosing decisions.

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


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

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

"The GlucoTrack CGM software development conforms to IEC 14971, with risk management per ISO 14971:2019."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 14971" which is incorrect. Wrong prefix. The correct standard is ISO 14971, not IEC 14971. All references must be corrected.


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

[User]
Expand requirement SRS-INTF-002: "sensor data link requirements" (Category: interface)
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: Communication with the primary sensor over FHIR MedicationDispense API shall include CRC-based error detection, automatic retry, and graceful degradation on persistent failure.
Rationale: Reliable sensor communication is the foundation of the Medication History Viewer data acquisition pipeline.
Priority: Mandatory
Acceptance Criterion: Error injection tests confirm 100% detection rate for corrupted frames and recovery within specified timeout.
Source: System requirement


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

[User]
Write a SRS section on latency and throughput requirements for NutriView Food Diary, a Class A Nutritional Tracking Display App. Reference IEC 62304 Clause 5.2.2.
Mobile app for manual food logging with nutritional summary display. No dietary recommendations or medical nutrition therapy.

[Assistant] Content: Timing requirements for the NutriView Food Diary include end-to-end latency from sensor acquisition to display update, processing throughput for sustained data streams, and startup time. Each timing requirement has a specific numeric bound and is verified through system testing of the Nutritional Tracking Display App.