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

[User]
Write a SDP section on development methodology for Class B for WoundTrack Healing Analyzer, a Class B Wound Assessment App. Reference IEC 62304 Clause 5.1.1.
Mobile app photographing wounds and measuring area/perimeter over time to track healing progress for clinician review.

[Assistant] Content: The WoundTrack Healing Analyzer 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 PhysioTrack Rehab (rehabilitation tracking system, Class B):

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

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


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

[User]
Expand requirement SRS-DATA-002: "stored data corruption detection" (Category: data)
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 DermaAssist Skin Lesion Classifier shall detect corrupted measurement records through integrity checking and flag affected entries for review.
Rationale: Data integrity mechanisms ensure measurement records retrieved from the Skin Lesion Classification App are trustworthy for clinical review.
Priority: Mandatory
Acceptance Criterion: Intentionally corrupted records are detected and flagged with 100% detection rate across 100 injected corruption events.
Source: System requirement


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

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

"For the MedInventory, verification consists of executing system tests against the software requirements. Class A software does not require formal unit testing, integration testing, or independent verification. Test results are recorded per Clause 5.7.5 and any anomalies are handled through the problem resolution process per Clause 9."

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


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

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

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

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


[System] You are an IEC 62304 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 lifecycle processes for the OxyPure Controller comply with IEC 62304-4."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304-4" which is incorrect. IEC 62304 has no Part 4. All references must be corrected.


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

[User]
Write a FMEA section on risk control verification for ClinTrial EDC Platform, a Class A Clinical Trial EDC Web Platform. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

[Assistant] Content: The ClinTrial EDC Platform risk control verification per Clause 7.3.1 exercises each control measure in isolation and in the context of the complete Clinical Trial EDC Web Platform. Clause 7.3.3 documentation records the verification method, the test result, and the conclusion regarding the control's effectiveness.


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

[User]
Write a SRS section on functional requirements overview 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: Functional requirements for the NutriView Food Diary are derived from the system requirements for Personal food logging and nutritional data visualization and from risk control measures identified in the ISO 14971 analysis. Each requirement specifies a single function of the Nutritional Tracking Display App with measurable acceptance criteria.


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

[User]
Expand requirement SRS-SEC-001: "access control and authorization" (Category: security)
Project: VibeCheck Vibration Analyzer | Vibration Analysis Instrument Firmware | Class A
Vibration spectrum analysis of industrial machinery for predictive maintenance. Portable vibration analysis firmware for predictive maintenance of industrial rotating machinery. FFT analysis of accelerometer data.

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

[Assistant]
Description: The VibeCheck Vibration Analyzer shall require authentication before allowing modification of device configuration parameters via BNC input.
Rationale: Access control prevents unauthorized modification of the Vibration Analysis Instrument Firmware operating parameters.
Priority: Mandatory
Acceptance Criterion: Configuration modification is rejected when attempted without valid credentials, verified across all configurable parameters.
Source: Risk control


[System] You are 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):

"IEC 62304-2 Section 7.1 requires all software units to be verified."

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


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

[User]
Write a TRACE section on purpose and scope of the traceability matrix for RadOnco Cloud Treatment Planner, a Class C Cloud Radiation Treatment Planning SaMD. Reference IEC 62304 Clause 5.7.1.
Cloud-based radiation oncology treatment planning system using GPU clusters for Monte Carlo dose calculation. Treatment plans directly drive linear accelerator delivery.

[Assistant] Content: The RadOnco Cloud Treatment Planner traceability matrix provides end-to-end requirement coverage evidence per Clause 5.7.1. Every SRS requirement for the Cloud Radiation Treatment Planning SaMD is traced to its implementing software item and to the verification test case(s) confirming correct implementation. Orphaned requirements and untested implementations are flagged for resolution.


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

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

"Compliance with IEC 62304 Clause 6.4 (post-market surveillance) and Clause 5.7.6 (performance benchmarking) is demonstrated."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 6.4 and 5.7.6, neither of which exists. Clause 6 has 6.1, 6.2, 6.3 only. Clause 5.7 has 5.7.1 through 5.7.5 only. All clause references must be corrected.


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

[User]
Write a THREAT section on system description for threat modeling for RespiRate Respiratory Monitor, a Class B Respiratory Rate Monitor Firmware. Reference IEC 62304 Clause 5.2.1.
Wearable firmware monitoring respiratory rate via chest impedance. Displays rate and alerts on bradypnea/tachypnea.

[Assistant] Content: The RespiRate Respiratory Monitor threat model scope encompasses the Respiratory Rate Monitor Firmware, its communication interfaces (I2C AFE, BLE 5.0), stored data, and the operational environment. Data flows between the bio-impedance electrodes and the application logic, and between the application and BLE 5.0 are analyzed for potential security threats.


[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):

"Configuration management is established. Configuration items are identified. Configuration items are controlled. Configuration status is reported. Configuration management is performed. Configuration is managed."

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


[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):

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

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


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

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

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

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


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

[User]
Expand requirement SRS-INTF-001: "IMU wearable communication specification" (Category: interface)
Project: TeleRehab Remote Patient Monitor | Remote Rehabilitation Platform | Class B
Remote physiotherapy monitoring with exercise tracking and therapist-patient video sessions. Platform enabling remote physiotherapy with video consultations and wearable sensor data streaming. Generates exercise adherence reports.

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

[Assistant]
Description: The TeleRehab Remote Patient Monitor shall communicate with the IMU wearable via WebRTC, implementing error detection and recovery for communication failures.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Remote Rehabilitation Platform output.
Priority: Mandatory
Acceptance Criterion: Error injection tests confirm 100% detection rate for corrupted frames and recovery within specified timeout.
Source: System requirement


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

[User]
Expand requirement SRS-FUNC-003: "power-on self-test sequence" (Category: functional)
Project: CleanRoom Particle Counter Logger | Cleanroom Environmental Logger | Class A
Logging and displaying airborne particle counts for cleanroom compliance. Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

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

[Assistant]
Description: A power-on self-test shall validate optical particle counter communication, memory integrity, and RS-485 Modbus connectivity before the Cleanroom Environmental Logger transitions to its operational state.
Rationale: A power-on self-test confirms hardware and software readiness before the Cleanroom Environmental Logger begins use.
Priority: Mandatory
Acceptance Criterion: All fault injection scenarios are detected with 100% reliability across 50 test iterations.
Source: System requirement


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

[User]
Write a FMEA section on risk control measures and implementation for RoomBoard Digital Signage, a Class A Patient Room Digital Signage. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Hospital room digital signage displaying patient name, care team, and daily schedule. Display-only, no clinical data entry.

[Assistant] Content: Risk control measures for the RoomBoard Digital Signage Patient Room Digital Signage are prioritized per Clause 7.2.1: inherently safe design first, then protective measures in software, then information for safety. Software-implemented controls per Clause 7.2.2 are expressed as verifiable requirements and traced to their originating hazard.


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

[User]
Expand requirement SRS-FUNC-006: "real-time data presentation on BLE 5.0" (Category: functional)
Project: HydroRemind Hydration Tracker | Hydration Tracking Firmware | Class A
Passive display of daily water consumption for wellness. Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

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

[Assistant]
Description: Output presentation on the BLE 5.0 shall refresh at the configured interval, reflecting the most recent processed data from the Hydration Tracking Firmware 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 RadView DICOM (DICOM image viewer, Class A):

"Each RadView DICOM 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 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: "alarm generation and notification" (Category: functional)
Project: ChestAI Pulmonary Nodule Detector | AI Pulmonary Nodule Detection SaMD | Class B
Computer-aided detection and measurement of pulmonary nodules on chest CT for radiologist review. Cloud AI SaMD analyzing chest CT scans to detect and measure pulmonary nodules, providing CAD overlay for radiologist review. FDA De Novo pathway.

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: Alarm thresholds shall be configurable per clinical protocol. The ChestAI Pulmonary Nodule Detector shall trigger alerts within the maximum allowable latency of a threshold crossing.
Rationale: Timely alarm generation is essential for the AI Pulmonary Nodule Detection SaMD 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 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 CleanRoom Particle Counter Logger, a Class A Cleanroom Environmental Logger. Reference IEC 62304 Clause 5.2.6.
Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

[Assistant] Content: Requirements verification for the CleanRoom Particle Counter Logger 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 Cleanroom Environmental Logger 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 system test execution and acceptance for Class A for PowerTrack UPS Monitor, a Class A UPS Monitoring Software. Reference IEC 62304 Clauses 5.7, 5.7.4.
Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

[Assistant] Content: System tests for the PowerTrack UPS Monitor are executed on the Linux server target with the UPS Monitoring Software operating in its intended configuration. Test results are recorded per Clause 5.7.5, and the system test is verified complete per Clause 5.7.4 when all requirements have a linked passing test. No unit tests or integration tests are produced, as Class A does not require these verification levels.


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

[User]
Write a SAD section on SOUP component integration and requirements for SleepScore Apnea Screening Tool, a Class B Sleep Apnea Screening App. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Mobile app analyzing overnight audio recordings to screen for obstructive sleep apnea indicators. Screening only, not diagnostic.

[Assistant] Content: Third-party software components used in the SleepScore Apnea Screening Tool are documented per Clause 5.3.3, including functional and performance requirements imposed on each SOUP item. Hardware and software dependencies per Clause 5.3.4 are recorded to ensure that the iOS + cloud environment satisfies all SOUP prerequisites.


[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 does IEC 62304 Class A require?

[Assistant]
IEC 62304 Class A is the least stringent safety class, for software that cannot contribute to a hazardous situation. Requirements include:

**Required:**
- Software development planning (Clause 5.1)
- Software requirements analysis (Clause 5.2)
- System testing (Clause 5.7)
- Software release (Clause 5.8)
- Risk management (Clause 7)
- Configuration management (Clause 8)
- Problem resolution (Clause 9)

**NOT required for Class A:**
- Software architectural design documentation (Clause 5.3)
- Software detailed design (Clause 5.4)
- Unit-level verification / unit testing (Clause 5.5)
- Integration testing (Clause 5.6)

Verification consists exclusively of system-level testing per Clause 5.7.


[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: "initialization integrity checks" (Category: functional)
Project: PulseRing Smart Ring Monitor | Wearable Smart Ring Firmware + Companion App | Class B
Continuous photoplethysmography-based heart rate and SpO2 monitoring via wearable ring with mobile companion. Wearable smart ring firmware measuring continuous PPG for heart rate and SpO2 with BLE streaming to companion mobile app for trend display.

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

[Assistant]
Description: Upon power-up, the PulseRing Smart Ring Monitor shall execute a self-test sequence verifying the integrity of the PPG LED array (green + red + IR) interface, internal memory, and output subsystem before entering operational mode.
Rationale: Startup verification prevents the Wearable Smart Ring Firmware + Companion App from operating with undetected faults that could affect output accuracy.
Priority: Mandatory
Acceptance Criterion: Self-test completes within the specified startup time and correctly detects each of the following injected faults: sensor disconnection, memory corruption, and display failure.
Source: System requirement


[System] You are an IEC 62304 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 ScheduleSync Appointment Manager, a Class A Appointment Scheduling System. Reference IEC 62304 Clause 5.2.2.
Web application for scheduling patient appointments across multiple clinics. Administrative scheduling only, no clinical workflow.

[Assistant] Content: The ScheduleSync Appointment Manager interfaces with external hardware via REST API. Interface requirements specify the physical layer, data format, sampling rate, and error handling for each connection. All interface requirements are verifiable through integration or system testing.


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

[User]
Write a SDP section on cybersecurity and health IT standards for BreathSync ICU Ventilator Controller, a Class C ICU Ventilator Controller Software. Reference IEC 62304 Clause 5.1.2.
Software controlling an ICU mechanical ventilator with multiple ventilation modes (volume, pressure, SIMV). Failure could result in patient death.

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


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

[User]
Expand requirement SRS-SEC-001: "authentication for configuration access" (Category: security)
Project: BreathSync ICU Ventilator Controller | ICU Ventilator Controller Software | Class C
Automated mechanical ventilation with multiple modes, alarm management, and patient synchronization. Software controlling an ICU mechanical ventilator with multiple ventilation modes (volume, pressure, SIMV). Failure could result in patient death.

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

[Assistant]
Description: Access to configuration and administrative functions of the ICU Ventilator Controller Software shall be restricted to authenticated and authorized users.
Rationale: Access control prevents unauthorized modification of the ICU Ventilator Controller Software operating parameters.
Priority: Mandatory
Acceptance Criterion: Brute-force protection activates after the specified number of failed authentication attempts.
Source: Risk control


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

[User]
Write a SAD section on SOUP risk evaluation and anomaly management for PhysioTrack Rehabilitation Monitor, a Class B Physical Therapy Tracking System. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

[Assistant] Content: Risk evaluation of SOUP in the PhysioTrack Rehabilitation Monitor follows Clause 7.1.3. Published anomaly lists are reviewed for each SOUP item deployed in the Physical Therapy Tracking System. Anomalies relevant to Tracking exercise performance and range of motion during physical therapy for therapist review are entered into the risk management file, and mitigations are implemented where the residual risk is unacceptable.


[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 FMEA scope for Class A -- simplified analysis for RadView DICOM Viewer, a Class A Medical Image Viewer. Reference IEC 62304 Clause 7.1.1.
Desktop application for viewing DICOM medical images. Display-only with standard windowing controls. No CAD or diagnostic measurement tools.

[Assistant] Content: Failure mode analysis for the Class A RadView DICOM Viewer is a confirmatory exercise documenting that no identified failure mode of the Medical Image Viewer creates a hazardous situation. The analysis systematically considers data loss, incorrect computation, and display errors, confirming that Read-only display of medical images for reference viewing remains safe even under worst-case software failure.


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

[User]
Write a SRS section on data format and interoperability requirements for LabView Results Portal, a Class A Laboratory Results Viewer. Reference IEC 62304 Clause 5.2.2.
Web application displaying laboratory test results retrieved from the hospital LIS. Read-only viewer with no result interpretation or flagging.

[Assistant] Content: The LabView Results Portal data format requirements ensure interoperability with external systems connected via HL7 FHIR API, HTTPS. Data structures, encoding schemes, and byte ordering are fully specified. The Laboratory Results Viewer handles version mismatches in data formats gracefully.


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

[User]
Write a SRS section on resource constraints and scalability for PhysioTrack Rehabilitation Monitor, a Class B Physical Therapy Tracking System. Reference IEC 62304 Clause 5.2.2.
Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

[Assistant] Content: The PhysioTrack Rehabilitation Monitor resource constraints are derived from the nRF52840 + web dashboard hardware capabilities. Requirements specify headroom margins for memory and processing to ensure the Physical Therapy Tracking System remains stable under sustained operation during Tracking exercise performance and range of motion during physical therapy for therapist review.


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

[User]
Write a SDP section on milestones and phase transition criteria for WeatherNode Microclimate Station, a Class A Weather Station Firmware. Reference IEC 62304 Clause 5.1.1.
Solar-powered weather station firmware measuring temperature, humidity, wind, rainfall, and barometric pressure.

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


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

[User]
Expand requirement SRS-INTF-002: "data export and interoperability" (Category: interface)
Project: DoseLog Radiation Badge Reader | Dosimetry Data Logger | Class A
Reading and archiving personal radiation exposure data from dosimeter badges. Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

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

[Assistant]
Description: The DoseLog Radiation Badge Reader shall exchange data with external systems via USB using the specified message format with error handling.
Rationale: External system connectivity is required for the Dosimetry Data Logger 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 HydroLog (hydration tracking wellness app, Class A):

"Cybersecurity considerations are addressed as applicable to the hydration tracking wellness app. Controls are implemented following industry best practices and guidance."

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


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

[User]
Write a SRS section on data format and interoperability requirements for HandGrip Strength Dynamometer, a Class B Hand Dynamometer Firmware. Reference IEC 62304 Clause 5.2.2.
Digital hand dynamometer firmware measuring grip strength and fatigue over repeated trials for rehabilitation assessment.

[Assistant] Content: The HandGrip Strength Dynamometer Hand Dynamometer Firmware data exchange formats are specified in this SRS with field-level definitions, data types, units, and valid ranges. The software performs schema validation on all incoming data from BLE 5.0 before processing.


[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 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: The RoomBoard Digital Signage cybersecurity posture is defined per IEC 81001-5-1:2021, covering threat modeling, secure design, vulnerability management, and incident response for the Patient Room Digital Signage. Health software product safety requirements from IEC 82304-1:2016 supplement the IEC 62304 lifecycle where applicable.


[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):

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

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

"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 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):

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

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


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

[User]
Write a SDP section on hazard identification for the specific device for StrokeAlert CT Perfusion Analyzer, a Class C AI Stroke Triage CT Perfusion SaMD. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Time-critical cloud SaMD processing CT perfusion scans to generate ischemic core and penumbra maps for acute stroke triage. Results pushed to mobile app within 5 minutes.

[Assistant] Content: Software-related hazard causes for the StrokeAlert CT Perfusion Analyzer AI Stroke Triage CT Perfusion SaMD are documented per Clause 7.1.2 and Clause 7.1.4. Risk control measures per Clause 7.2.1 address each identified cause through input validation, range checking, communication integrity verification, and fail-safe defaults.


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

[User]
Write a SRS section on requirements conventions and identification scheme for HeartView Resting HR Display, a Class A Heart Rate Display Firmware. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Wearable firmware that shows resting heart rate on a small OLED screen. Read-only display with no arrhythmia detection or clinical alerts.

[Assistant] Content: Requirements in this SRS are identified using the format SRS-HEA-NNN, where NNN is a sequential number. Each requirement states a single testable capability per Clause 5.2.2 and is classified as functional, performance, interface, or safety. Derived requirements that do not trace to a system requirement are flagged for separate review.


[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: "user-configurable operating parameters" (Category: functional)
Project: FactoryTemp Industrial Temperature Monitor | Industrial Temperature Monitoring Firmware | Class A
Continuous monitoring and logging of factory floor temperatures for process control. Firmware monitoring factory floor temperatures from distributed thermocouple arrays. Logs data for process control compliance.

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

[Assistant]
Description: Operating parameters of the Industrial Temperature Monitoring Firmware shall be user-configurable within validated ranges and stored in non-volatile memory.
Rationale: Parameter flexibility is essential for the Industrial Temperature Monitoring 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 a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SDP section on development methodology for Class A for ConveyorGuard Safety Interlock System, a Class A Conveyor Safety Interlock Software. Reference IEC 62304 Clause 5.1.1.
Safety PLC program monitoring conveyor belt guard positions, emergency stops, and light curtains. Functional safety application.

[Assistant] Content: Development of the ConveyorGuard Safety Interlock System uses an incremental build approach with three formal gates: requirements agreement, code complete, and release readiness. The Class A designation means verification focuses on system testing (Clause 5.7) and no separate architecture or unit verification phases are scheduled.


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

[User]
Write a SDP section on risk management integration into the lifecycle for WeightAlert Neonatal Scale, a Class B Neonatal Scale Firmware. Reference IEC 62304 Clauses 7.1, 7.1.1.
Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

[Assistant] Content: Risk management for the WeightAlert Neonatal Scale follows IEC 62304 Clause 7 and ISO 14971:2019. Hazard identification per Clause 7.1.1 is performed during requirements analysis and updated as the Neonatal Scale Firmware design evolves. Risk control measures are traced to software requirements and verified through the testing activities defined in this plan.


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

[User]
Write a SDP section on lightweight review process for Class A for HeartView Resting HR Display, a Class A Heart Rate Display Firmware. Reference IEC 62304 Clause 5.1.1.
Wearable firmware that shows resting heart rate on a small OLED screen. Read-only display with no arrhythmia detection or clinical alerts.

[Assistant] Content: For the Class A HeartView Resting HR Display, deliverable reviews are conducted by the project lead, who confirms technical completeness, and the quality representative, who confirms process compliance. Reviews are documented with sign-off records. No independent reviewer external to the project team is mandated.


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

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

[Assistant] Content: The SleepScore Apnea Screening Tool Sleep Apnea Screening App presents information to the user via audio API and accepts user input through defined interaction patterns. User interaction requirements are traceable to the usability engineering file per IEC 62366-1:2015+AMD1:2020.


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

[User]
Write a SDP section on requirements verification approach for WeatherNode Microclimate Station, a Class A Weather Station Firmware. Reference IEC 62304 Clause 5.2.6.
Solar-powered weather station firmware measuring temperature, humidity, wind, rainfall, and barometric pressure.

[Assistant] Content: Verification of WeatherNode Microclimate Station software requirements follows Clause 5.2.6. Reviewers confirm that every requirement is complete, consistent, testable, and traceable. Requirements that implement risk controls are additionally verified against the ISO 14971 risk management file for the Weather Station Firmware.


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

[User]
Write a TRACE section on purpose and scope of the traceability matrix for DoseCalc Medication Calculator, a Class B Medication Dose Calculator App. Reference IEC 62304 Clause 5.7.1.
Mobile app calculating medication doses based on patient weight, age, and renal function. Incorrect calculations could cause underdosing or adverse effects.

[Assistant] Content: The DoseCalc Medication Calculator traceability matrix provides end-to-end requirement coverage evidence per Clause 5.7.1. Every SRS requirement for the Medication Dose Calculator 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 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):

"Verification activities follow IEC 62304 Clause 6.4 for operational qualification."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 6.4 which does not exist. Clause 6 has 6.1, 6.2, 6.3 only. 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 SRS section on resource constraints and scalability for InfuRate IV Flow Calculator, a Class B Infusion Rate Calculator. Reference IEC 62304 Clause 5.2.2.
Desktop calculator for IV infusion rates based on drug concentration, patient weight, and ordered dose. Clinical decision support tool.

[Assistant] Content: The InfuRate IV Flow Calculator shall operate within the memory, storage, and processing constraints of the Windows/macOS desktop platform. Resource usage requirements are specified with numerical bounds and verified through profiling during system testing of the Infusion Rate Calculator.


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

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

[Assistant]
Description: The FetalGuard Heart Rate Monitor shall exchange data with external systems via analog signal conditioning using the specified message format with error handling.
Rationale: External system connectivity is required for the Fetal Heart Rate Monitor Firmware to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


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

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

"The CardioPulse Monitor addresses IEC 62304 Clause Annex B.3 for data archival and Clause Annex A.1 for user acceptance testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses Annex B.3 and Annex A.1, neither of which exists. IEC 62304 annexes are not cited as requirements. IEC 62304 annexes are informative, not cited as requirements. All clause references must be corrected.


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

[User]
Write a SRS section on enhanced security for Class B and C for CardioCloud ECG Analysis Service, a Class B Cloud ECG Analysis SaMD. Reference IEC 62304 Clause 5.2.2.
Cloud SaaS platform receiving 12-lead ECG recordings from clinics, running automated arrhythmia detection, and returning annotated results via FHIR API.

[Assistant] Content: The CardioCloud ECG Analysis Service Cloud ECG Analysis SaMD implements security-in-depth: secure boot, runtime integrity monitoring, encrypted communications, and input validation on all external interfaces per IEC 81001-5-1:2021. Security testing covers penetration testing, fuzz testing of REST API, and vulnerability scanning.


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

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

"Compliance with IEC 62304 Clause 5.5.2.1 (detailed design verification) and Clause 5.0 (deployment validation) is demonstrated."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.5.2.1 and 5.0, neither of which exists. IEC 62304 has no four-level numbering. Clause 5 starts at 5.1. All clause references must be corrected.


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

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

[Assistant] Content: Resource requirements for the SleepScore Apnea Screening Tool specify maximum memory utilization, persistent storage consumption, and processor loading on iOS + cloud. The Sleep Apnea Screening App must operate within these constraints under worst-case conditions without degradation of safety-relevant functions.


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

[User]
Expand requirement SRS-SAFE-001: "safe state transition on critical failure" (Category: safety)
Project: PedDose Pediatric Dosing App | Pediatric Dosing Calculator App | Class B
Weight-based pediatric dose calculations with age-appropriate range checking. Mobile reference app for pediatric drug dosing with weight-based calculations and age-specific ranges.

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

[Assistant]
Description: The Pediatric Dosing Calculator App shall enter a defined safe state within the maximum allowable transition time when a critical fault is detected, ensuring no hazardous output persists.
Rationale: A deterministic safe-state transition prevents the Pediatric Dosing Calculator App from operating in an unknown or hazardous state after a detected fault.
Priority: Mandatory
Acceptance Criterion: Safe state transition completes within the specified time limit for each defined critical fault, verified by fault injection during operation.
Source: Risk control


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

[User]
Write a SDP section on development methodology for Class B for VitalPulse SpO2 Monitor, a Class B Pulse Oximeter Firmware. Reference IEC 62304 Clause 5.1.1.
Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

[Assistant] Content: The VitalPulse SpO2 Monitor 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 an IEC 62304 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

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

"Architectural design follows ISO 14971-2 Clause 5.3 for Class C devices."

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


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

[User]
Write a SDP section on change control and trend analysis for problems for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clauses 9.4, 9.6.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: All CochleaMap CI Fitting Software problem corrections enter the change control process per Clause 9.4 before integration into the baseline. Trend analysis per Clause 9.6 tracks defect density, time-to-resolution, and defect category distribution across the Cochlear Implant Fitting Software development lifecycle to drive process improvement.


[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 threat model data flow decomposition 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 threat model decomposes the Linear Accelerator Control Software into data flow diagrams showing all external entities, processes, data stores, and data flows. Each data flow crossing a trust boundary is analyzed for threats. The decomposition covers ionization chamber (x2) input, internal processing, and output via real-time fieldbus.


[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 CardioCloud ECG Analysis Service, a Class B Cloud ECG Analysis SaMD. Reference IEC 62304 Clause 5.3.2.
Cloud SaaS platform receiving 12-lead ECG recordings from clinics, running automated arrhythmia detection, and returning annotated results via FHIR API.

[Assistant] Content: The CardioCloud ECG Analysis Service architecture defines error propagation rules at each interface per Clause 5.3.2. Invalid data from input sources is detected at the acquisition boundary and does not propagate into processing stages. Each software item validates its inputs and reports errors through a defined error channel in the Cloud ECG Analysis SaMD.


[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):

"Risk control measures are implemented per IEC 62304:2015 Clause 7."

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

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

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

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


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

[User]
Write a SDP section on requirements elicitation and documentation for GlucoEdge Continuous Glucose Platform, a Class B Hybrid CGM Edge-Cloud Platform. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Hybrid system: embedded BLE firmware on a wearable CGM patch streams readings to a phone app, which uploads to cloud for trend analysis and physician dashboard.

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


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

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

"The StepTrack verification approach is commensurate with Class A risk. System tests validate end-to-end functionality. No formal code coverage metrics are required. The developer may self-verify test results."

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


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

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

"An independent verification and validation (IV&V) team reviews all SleepWell development artifacts and test results before release approval."

[Assistant]
Verdict: FAIL
Note: Content mandates independent verification and validation (IV&V) for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Independent verification is required only for Class C.


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

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

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

[Assistant]
Verdict: FAIL
Note: The documentation section exhibits repeated project name. The project name 'RetinaScan Pro' appears excessively. Sentences repeat the same assertion about the diabetic retinopathy screening AI in different words. Content should be consolidated and each sentence should contribute unique, specific information about the RetinaScan Pro.


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

[User]
Expand requirement SRS-DATA-002: "record keeping duration" (Category: data)
Project: StrokeAlert CT Perfusion Analyzer | AI Stroke Triage CT Perfusion SaMD | Class C
Rapid automated CT perfusion analysis generating ischemic core and penumbra maps for acute stroke treatment decisions. Time-critical cloud SaMD processing CT perfusion scans to generate ischemic core and penumbra maps for acute stroke triage. Results pushed to mobile app within 5 minutes.

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

[Assistant]
Description: The StrokeAlert CT Perfusion Analyzer shall retain measurement data in non-volatile storage for the specified minimum retention period, after which data may be overwritten.
Rationale: Data retention supports clinical trend analysis and regulatory requirements for record keeping associated with the AI Stroke Triage CT Perfusion SaMD.
Priority: Mandatory
Acceptance Criterion: Oldest data record remains retrievable after continuous operation for the specified retention period.
Source: Regulatory


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

[User]
Write a SAD section on SOUP risk evaluation and anomaly management for NutriCalc TPN Formulation Tool, a Class B TPN Formulation Calculator. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

[Assistant] Content: Risk evaluation of SOUP in the NutriCalc TPN Formulation Tool follows Clause 7.1.3. Published anomaly lists are reviewed for each SOUP item deployed in the TPN Formulation Calculator. Anomalies relevant to Calculating TPN component concentrations and volumes based on nutritional requirements are entered into the risk management file, and mitigations are implemented where the residual risk is unacceptable.


[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):

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

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


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

[User]
Write a SRS section on data processing and transformation requirements for PhysioTrack Rehabilitation Monitor, a Class B Physical Therapy Tracking System. Reference IEC 62304 Clause 5.2.2.
Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

[Assistant] Content: The PhysioTrack Rehabilitation Monitor shall process data from IMU (accelerometer + gyroscope) and transform it into clinically meaningful output for Tracking exercise performance and range of motion during physical therapy for therapist review. Data processing requirements specify input validation rules, algorithm accuracy tolerances, and output format constraints for the Physical Therapy Tracking System.


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

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

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

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the EchoAssist (echocardiogram analysis aid, Class B). Standards references are accurate.


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

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

"The PillRemind shall undergo static code analysis with all warnings treated as errors, followed by unit testing with decision coverage of at least 75%."

[Assistant]
Verdict: FAIL
Note: Content mandates static analysis and unit testing with decision coverage for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Unit verification (Clause 5.5) and static analysis requirements are not mandated for Class A.


[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: "force-sensitive resistors (FSR array) communication specification" (Category: interface)
Project: GaitSense Walking Analysis | Gait Analysis Insole Firmware | Class B
Quantitative gait analysis using instrumented insoles for orthopedic and rehabilitation assessment. Instrumented insole firmware analyzing gait patterns and detecting asymmetries. Reports generated for orthopedic 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 Gait Analysis Insole Firmware sensor interface shall establish and maintain reliable communication with the force-sensitive resistors (FSR array) via BLE 5.0.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Gait Analysis Insole Firmware output.
Priority: Mandatory
Acceptance Criterion: Error injection tests confirm 100% detection rate for corrupted frames and recovery within specified timeout.
Source: System requirement


[System] You are a 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):

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

[User]
Write a SDP section on Class A classification justification and implications for AutoHUD Heads-Up Display Controller, a Class A Automotive HUD Controller Firmware. Reference IEC 62304 Clause 4.3.
Firmware rendering vehicle speed, navigation, and ADAS warnings on a windshield-projected heads-up display.

[Assistant] Content: The AutoHUD Heads-Up Display Controller Automotive HUD Controller Firmware receives a Class A safety classification because its failure modes result exclusively in loss of non-critical functionality. The software performs Rendering critical driving information on a windshield heads-up display without affecting clinical decisions, therapeutic delivery, or patient monitoring that requires fail-safe behavior. This classification means detailed design (Clause 5.4), unit verification (Clause 5.5), and integration testing (Clause 5.6) are 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 SRS section on purpose of the SRS document for FleetTrack GPS Tracking Module, a Class A Fleet GPS Tracking Firmware. Reference IEC 62304 Clause 5.2.1.
Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

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


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

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

"The RetinaScan Pro Class B verification includes integration testing per Clause 5.6 and system testing per Clause 5.7. Integration tests verify inter-module interfaces. Statement coverage of at least 80% is targeted for unit tests where performed. The development team performs verification activities."

[Assistant]
Verdict: PASS
Note: Content correctly specifies Class B requirements. Standards references are accurate.


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

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

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

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as appropriate", "applicable requirements" provide no project-specific information about the LabView Portal read-only lab results viewer. 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 DialysisGuard (hemodialysis machine controller, Class C):

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

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


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

[User]
Write a SDP section on scope boundaries of the software system for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clauses 5.1.1, 5.1.2.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: The software system boundary for CochleaMap CI Fitting Software encompasses the Cochlear Implant Fitting Software application and its direct interfaces: USB programming cable, desktop GUI. Components outside this boundary -- including electrode impedance measurement hardware, manufacturing test fixtures, and third-party cloud services -- are addressed in the system-level risk analysis but are not governed by this plan.


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

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

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

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


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

[User]
Write a THREAT section on system description for threat modeling for PedDose Pediatric Dosing App, a Class B Pediatric Dosing Calculator App. Reference IEC 62304 Clause 5.2.1.
Mobile reference app for pediatric drug dosing with weight-based calculations and age-specific ranges.

[Assistant] Content: The system description for the PedDose Pediatric Dosing App threat model identifies all assets requiring protection: patient data, device configuration, firmware integrity, and the availability of the Pediatric Dosing Calculator App for Weight-based pediatric dose calculations with age-appropriate range checking. Trust boundaries are drawn at each external interface: local drug database, manual input.


[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 GaitSense Walking Analysis, a Class B Gait Analysis Insole Firmware. Reference IEC 62304 Clause 5.2.2.
Instrumented insole firmware analyzing gait patterns and detecting asymmetries. Reports generated for orthopedic assessment.

[Assistant] Content: Computational resource requirements for the GaitSense Walking Analysis define the maximum CPU utilization, RAM consumption, and flash/disk usage permitted on nRF52832. The Gait Analysis Insole Firmware must meet all functional and timing requirements within these resource envelopes.


[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 software architecture defines three software items with documented interfaces per Clause 5.3.2. Data formats, protocols, and error handling are specified for each interface. SOUP components are identified per Clause 5.3.3."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the CardioPulse Monitor (cardiac rhythm monitor, Class B). Standards references are accurate.


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

[User]
Expand requirement SRS-PERF-003: "end-to-end processing latency" (Category: performance)
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: Processing latency of the Skin Lesion Classification App shall be bounded to ensure timely output that reflects current input conditions.
Rationale: Bounded processing latency ensures the Skin Lesion Classification App 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 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

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

"Compliance with IEC 62304 Clause 6.4 (user acceptance testing) and Clause 5.8.9 (post-market surveillance) is demonstrated."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 6.4 and 5.8.9, neither of which exists. Clause 6 has 6.1, 6.2, 6.3 only. Clause 5.8 has 5.8.1 through 5.8.8 only. All clause references must be corrected.


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

[User]
Write a SDP section on internal SOPs and procedures for RetinaScan Diabetic Retinopathy Screener, a Class B Retinal Screening Software. Reference IEC 62304 Clause 5.1.2.
Desktop software analyzing retinal fundus images to detect signs of diabetic retinopathy for ophthalmologist review.

[Assistant] Content: Company-internal standard operating procedures supplement the international standards for the RetinaScan Diabetic Retinopathy Screener project. SOP-010 through SOP-013 address development planning, risk management, configuration management, and verification planning. All SOPs are part of the ISO 13485 quality management system and are binding on the Retinal Screening Software development team.


[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 management integration into the lifecycle for LabView Results Portal, a Class A Laboratory Results Viewer. Reference IEC 62304 Clauses 7.1, 7.1.1.
Web application displaying laboratory test results retrieved from the hospital LIS. Read-only viewer with no result interpretation or flagging.

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


[System] You are 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 TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clause 5.2.2.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

[Assistant] Content: Resource requirements for the TriageAI Emergency Triage Assistant specify maximum memory utilization, persistent storage consumption, and processor loading on iPad web app. The ED Triage Decision Support App must operate within these constraints under worst-case conditions without degradation of safety-relevant functions.


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

[User]
Expand requirement SRS-SAFE-001: "safety classification confirmation for Class A" (Category: safety)
Project: ConsentView Informed Consent Archive | Consent Document Viewer | Class A
Read-only viewing of archived informed consent documents. Web portal for patients and staff to view signed informed consent documents. Read-only document viewer.

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 ConsentView Informed Consent Archive software shall not implement any function that could directly control a therapeutic output, modify a diagnostic conclusion, or trigger a clinical alert, consistent with its Class A classification.
Rationale: The Class A classification of the Consent Document Viewer depends on the software having no path to contribute to a hazardous situation.
Priority: Mandatory
Acceptance Criterion: Code review confirms no software path exists that controls therapeutic outputs, modifies diagnostic results, or generates clinical alerts.
Source: Regulatory


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

[User]
Write a FMEA section on risk control verification for SurgiPlan 3D Surgical Planner, a Class B 3D Surgical Planning SaMD. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Desktop SaMD for orthopedic surgeons to plan joint replacement procedures on 3D CT reconstructions. Outputs implant sizing and positioning specifications.

[Assistant] Content: The SurgiPlan 3D Surgical Planner risk control verification per Clause 7.3.1 exercises each control measure in isolation and in the context of the complete 3D Surgical Planning SaMD. Clause 7.3.3 documentation records the verification method, the test result, and the conclusion regarding the control's effectiveness.


[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):

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

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


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

[User]
Write a SRS section on data retention and integrity requirements for BrachyDose HDR Afterloader Controller, a Class C HDR Brachytherapy Afterloader Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware controlling high-dose-rate brachytherapy source positioning and dwell times. Source positioning errors cause lethal local radiation.

[Assistant] Content: Persistent data managed by the BrachyDose HDR Afterloader Controller includes configuration parameters, acquired measurements from source position encoder, and operational logs. Data integrity requirements specify error detection mechanisms and the HDR Brachytherapy Afterloader Firmware response to data corruption events.