[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] Can I cite IEC 62366-1:2015+AMD1:2020 in my documentation?

[Assistant] Yes. IEC 62366-1:2015+AMD1:2020 is the current edition of the usability engineering standard for medical devices. Note: this standard does have a Part 1, and IEC 62366-2 exists as a technical report with guidance.


[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: "display update rate for Surgical Documentation App" (Category: functional)
Project: SurgLog Procedure Documentation App | Surgical Documentation App | Class A
Documentation and review of surgical procedure notes. Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

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

[Assistant]
Description: The SurgLog Procedure Documentation App shall update the displayed values on the REST API at intervals no greater than the specified refresh period.
Rationale: Timely display updates ensure the user observes current readings without perceiving lag.
Priority: Mandatory
Acceptance Criterion: Measured display update interval is within 10% of the specified refresh period across 100 consecutive update cycles.
Source: User need


[System] You are a regulatory 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):

"ISO 62304 Section 8.1 requires all software units to be verified."

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


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

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

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

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


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

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

"All verification for the neurostimulator programmer follows ISO 14971-1 requirements."

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


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

[User]
Expand requirement SRS-SAFE-002: "fault response and safe shutdown" (Category: safety)
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 AI Stroke Triage CT Perfusion SaMD shall enter a defined safe state within the maximum allowable transition time when a critical fault is detected, ensuring no hazardous output persists.
Rationale: Fail-safe behavior is essential to prevent the AI Stroke Triage CT Perfusion SaMD from causing harm when its software detects an unrecoverable error.
Priority: Mandatory
Acceptance Criterion: Safe state transition completes within the specified time limit for each defined critical fault, verified by fault injection during operation.
Source: Risk control


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

[User]
Write a SRS section on requirements conventions and identification scheme for VitalPulse SpO2 Monitor, a Class B Pulse Oximeter Firmware. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

[Assistant] Content: Requirements for the VitalPulse SpO2 Monitor Pulse Oximeter Firmware are documented per Clause 5.2.2 with clear acceptance criteria enabling direct derivation of test cases. Each requirement traces backward to its source and forward to its verification activity in the traceability matrix.


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

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

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

[Assistant]
Description: Data retention in the HemaCount Digital Cell Counter shall meet the specified minimum duration, with oldest records overwritten only after the retention period expires.
Rationale: Regulatory compliance requires that measurement records be available for the specified retention period.
Priority: Mandatory
Acceptance Criterion: Retention period validation: records created at time T are still accessible at T + retention period.
Source: Regulatory


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

[User]
Write a SDP section on scope boundaries of the software system for RadView DICOM Viewer, a Class A Medical Image Viewer. Reference IEC 62304 Clauses 5.1.1, 5.1.2.
Desktop application for viewing DICOM medical images. Display-only with standard windowing controls. No CAD or diagnostic measurement tools.

[Assistant] Content: Scope is limited to the RadView DICOM Viewer software items developed under this plan and released as a single configuration baseline. Peripherals, test jigs, and cloud infrastructure used during Read-only display of medical images for reference viewing are addressed by separate system-level documentation and are not governed by IEC 62304 Clause 5.1.1 activities described herein.


[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: "absence of safety-critical functions" (Category: safety)
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: The Hydration Tracking Firmware software functions are limited to informational display and data presentation, with no capability to influence clinical decisions or therapeutic actions.
Rationale: Confirming the absence of safety-relevant functions validates the Class A classification under IEC 62304 Clause 4.3.
Priority: Mandatory
Acceptance Criterion: Architecture review demonstrates complete absence of safety-critical software functions in the Hydration Tracking Firmware.
Source: Regulatory


[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 RespiRate Respiratory Monitor, a Class B Respiratory Rate Monitor Firmware. Reference IEC 62304 Clause 5.2.2.
Wearable firmware monitoring respiratory rate via chest impedance. Displays rate and alerts on bradypnea/tachypnea.

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


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

[User]
Expand requirement SRS-SAFE-001: "fault response and safe shutdown" (Category: safety)
Project: FallRisk Inpatient Assessment Tool | Fall Risk Assessment App | Class B
Calculating fall risk scores for hospitalized patients to guide nursing interventions. Web app calculating fall risk scores for inpatients based on mobility, medication, and cognitive assessments.

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

[Assistant]
Description: Upon detection of a critical software fault, the FallRisk Inpatient Assessment Tool shall transition to its defined safe state within the specified time, disabling any active output that could contribute to harm.
Rationale: A deterministic safe-state transition prevents the Fall Risk Assessment App from operating in an unknown or hazardous state after a detected fault.
Priority: Mandatory
Acceptance Criterion: All 20 defined fault scenarios result in correct safe-state entry within timing limits across 10 iterations each.
Source: Risk control


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

[User]
Write a SDP section on risk control requirements traceability for RetinaScan Diabetic Retinopathy Screener, a Class B Retinal Screening Software. Reference IEC 62304 Clause 5.2.3.
Desktop software analyzing retinal fundus images to detect signs of diabetic retinopathy for ophthalmologist review.

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


[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):

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

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


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

[User]
Expand requirement SRS-FUNC-005: "initialization integrity checks" (Category: functional)
Project: SupplyChain Procurement Portal | Supply Chain Procurement System | Class A
Managing procurement of medical supplies with approval tracking. Web portal for ordering medical supplies with approval workflows. Procurement and logistics only.

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

[Assistant]
Description: Upon power-up, the SupplyChain Procurement Portal shall execute a self-test sequence verifying the integrity of the primary sensor interface, internal memory, and output subsystem before entering operational mode.
Rationale: Startup verification prevents the Supply Chain Procurement System from operating with undetected faults that could affect output accuracy.
Priority: Mandatory
Acceptance Criterion: All fault injection scenarios are detected with 100% reliability across 50 test iterations.
Source: System requirement


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

[User]
Write a SDP section on requirements verification approach for RoomBoard Digital Signage, a Class A Patient Room Digital Signage. Reference IEC 62304 Clause 5.2.6.
Hospital room digital signage displaying patient name, care team, and daily schedule. Display-only, no clinical data entry.

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


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

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

[Assistant] Content: System boundaries for the AutoclaveLog Cycle Recorder are defined at the software interface level. The Sterilization Cycle Data Logger receives input from external sensors and produces output via RS-232 serial. Components beyond these interfaces are outside the scope of this SRS and are addressed in system-level documentation.


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

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

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

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


[System] You are a 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-002: "data-at-rest encryption" (Category: security)
Project: CogniTest Cognitive Assessment App | Cognitive Assessment Application | Class B
Administering and scoring standardized cognitive screening tests for clinical neuropsychological assessment. Tablet app administering standardized cognitive screening tests and scoring results. Used by neuropsychologists in clinical settings.

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

[Assistant]
Description: The CogniTest Cognitive Assessment App shall encrypt patient-identifiable data at rest, ensuring that raw storage access cannot reveal protected health information.
Rationale: Encryption of stored patient data protects against unauthorized disclosure if the Cognitive Assessment Application storage media is accessed outside the intended context.
Priority: Mandatory
Acceptance Criterion: Cryptographic implementation validated against NIST standards with no known vulnerabilities in the selected algorithm.
Source: Regulatory


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

[User]
Expand requirement SRS-INTF-002: "clinical system integration interface" (Category: interface)
Project: MedRef Clinical Reference App | Clinical Drug Reference App | Class A
Providing searchable drug information and interaction warnings for clinical reference without making prescribing decisions. Standalone mobile app providing searchable drug reference database with interaction checker. Display-only — no prescription or dosing decisions.

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

[Assistant]
Description: Data interoperability with clinical information systems shall be provided through REST API for DB sync, supporting standard message formats.
Rationale: Interoperability enables integration of Clinical Drug Reference App data into the clinical workflow and patient record.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


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

[User]
Write a SDP section on internal SOPs and procedures for StrokeAlert CT Perfusion Analyzer, a Class C AI Stroke Triage CT Perfusion SaMD. Reference IEC 62304 Clause 5.1.2.
Time-critical cloud SaMD processing CT perfusion scans to generate ischemic core and penumbra maps for acute stroke triage. Results pushed to mobile app within 5 minutes.

[Assistant] Content: Work instructions for the StrokeAlert CT Perfusion Analyzer are codified in SOPs maintained within the ISO 13485 quality management system. SOP-010 (development planning), SOP-011 (risk management), SOP-012 (configuration management), and SOP-013 (verification) define step-by-step procedures for each IEC 62304 lifecycle activity applicable to the AI Stroke Triage CT Perfusion SaMD.


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

[User]
Write a SDP section on hazard identification for the specific device for BillingBridge Claims Processor, a Class A Claims Processing Service. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Backend service processing insurance claims from the hospital billing system. Financial processing only, no clinical data.

[Assistant] Content: Hazard identification for the BillingBridge Claims Processor per Clause 7.1.2 considers all software functions that could contribute to patient harm. Identified causes include incorrect sensor data processing, loss of communication on X12 EDI, and failure to detect out-of-range conditions during Automated processing and submission of insurance claims.


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

[User]
Write a SAD section on architecture verification scope for GlucoEdge Continuous Glucose Platform, a Class B Hybrid CGM Edge-Cloud Platform. Reference IEC 62304 Clauses 5.3.1, 5.3.6.
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: This architecture is subject to verification per Clause 5.3.6 before the GlucoEdge Continuous Glucose Platform proceeds to implementation. Reviewers confirm that the architecture addresses all SRS requirements, interfaces are fully specified, and SOUP items are integrated per Clause 5.3.3.


[System] You are 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):

"ISO 14971-1 Section 4.3 requires all software units to be verified."

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


[System] You are a regulatory 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 FridgeGuard Temperature Logger, a Class A Cold Chain Temperature Logger. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Firmware logging refrigerator temperatures for vaccine and medication cold chain compliance. Records and displays data, no alerts that drive clinical decisions.

[Assistant] Content: The FridgeGuard Temperature Logger SOUP risk assessment per Clause 7.1.3 documents all known SOUP defects relevant to the Cold Chain Temperature Logger operational context. Where a SOUP defect could contribute to a hazardous situation, the architecture implements a software-level mitigation or the affected SOUP component is replaced.


[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 StepSync Activity Tracker, a Class A Wellness Activity Display App. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Mobile app displaying daily step count, distance, and calories from a wrist-worn accelerometer. Read-only display with no clinical interpretation.

[Assistant] Content: The StepSync Activity Tracker Wellness Activity Display App integrates SOUP components per Clause 5.3.3 with specified functional requirements and per Clause 5.3.4 with documented hardware/software prerequisites. Each SOUP item's known anomaly list has been evaluated per Clause 7.1.3 and documented in the risk management file.


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

[User]
Write a SAD section on architectural overview for Class C with segregation for LinacControl Beam Delivery System, a Class C Linear Accelerator Control Software. Reference IEC 62304 Clauses 5.3.1, 5.3.2, 5.3.5.
Software controlling linear accelerator beam delivery during radiation therapy. Beam-on errors could deliver lethal radiation doses.

[Assistant] Content: The LinacControl Beam Delivery System Linear Accelerator Control Software architecture implements segregation per Clause 5.3.5 to isolate safety-critical software items from non-safety items. The safety-critical path -- from ionization chamber (x2) acquisition through processing to safety output -- is architecturally independent from auxiliary functions. This segregation supports the Class C verification strategy including independent 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 SOUP identification and management for WeatherNode Microclimate Station, a Class A Weather Station Firmware. Reference IEC 62304 Clause 8.1.2.
Solar-powered weather station firmware measuring temperature, humidity, wind, rainfall, and barometric pressure.

[Assistant] Content: SOUP components in the WeatherNode Microclimate Station are catalogued per Clause 8.1.2 with title, version, supplier, and license terms. The risk management process evaluates each SOUP item's known anomaly list per Clause 7.1.3 to determine whether any published defect could contribute to a hazardous situation in the 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 SRS section on external system communication requirements for DoseLog Radiation Badge Reader, a Class A Dosimetry Data Logger. Reference IEC 62304 Clause 5.2.2.
Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

[Assistant] Content: Requirements for external system integration with the DoseLog Radiation Badge Reader specify the API contracts, data formats, and error handling behavior for all outbound communication from the Dosimetry Data Logger. The software must handle connection timeouts, malformed responses, and authentication failures without affecting safety-relevant functions.


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

[User]
Write a SDP section on requirements verification approach for AuditTrail QMS Event Logger, a Class A QMS Audit Trail Service. Reference IEC 62304 Clause 5.2.6.
Microservice capturing and storing quality management system audit events. Logging and reporting only.

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


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

[User]
Write a SDP section on safety classification process and documentation for TransVent Transport Ventilator, a Class C Transport Ventilator Firmware. Reference IEC 62304 Clause 4.3.
Portable transport ventilator firmware for ambulance and helicopter use. Must maintain ventilation under vibration and altitude changes.

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


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

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

"The GlucoTrack CGM development plan specifies Class B rigor: architectural design with interface documentation, integration testing of all inter-component interfaces, and system-level verification. Unit testing is recommended and will be performed for safety-related modules."

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


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

[User]
Write a SDP section on test records and acceptance criteria for Class B for RetinaScan Diabetic Retinopathy Screener, a Class B Retinal Screening Software. Reference IEC 62304 Clauses 5.6.7, 5.7.5.
Desktop software analyzing retinal fundus images to detect signs of diabetic retinopathy for ophthalmologist review.

[Assistant] Content: Test deliverables for the RetinaScan Diabetic Retinopathy Screener at Class B include the integration test report per Clause 5.6.7 and the system test report per Clause 5.7.5. Each report documents the test configuration, test procedures, results, and any deviations. The Retinal Screening Software is accepted when all test cases pass and the traceability matrix shows complete coverage.


[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):

"Verification of the SleepWell consists exclusively of system-level testing per IEC 62304 Clause 5.7. Test cases derive from the software requirements specification and execute against the sleep quality display app in its target environment. Unit-level and integration testing are not required for Class A and are not performed."

[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 StepTrack (wellness pedometer app, Class A):

"The StepTrack verification approach includes system testing per Clause 5.7 with test cases documented in the software test plan. The developer may perform verification activities. Independent review is not required for Class A. No integration or unit testing is mandated for this wellness pedometer app."

[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 verification strategy for Class B -- integration and system testing for HandGrip Strength Dynamometer, a Class B Hand Dynamometer Firmware. Reference IEC 62304 Clauses 5.6, 5.6.3, 5.7.
Digital hand dynamometer firmware measuring grip strength and fatigue over repeated trials for rehabilitation assessment.

[Assistant] Content: Class B verification for the HandGrip Strength Dynamometer requires integration testing (Clause 5.6) and system testing (Clause 5.7). Integration test cases are derived from the software architecture interfaces. System test cases are derived from the SRS. Unit testing of individual modules is performed where risk analysis identifies safety-relevant code, but is not mandated by the Class B classification.


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

[User]
Write a SDP section on internal SOPs and procedures for ConveyorGuard Safety Interlock System, a Class A Conveyor Safety Interlock Software. Reference IEC 62304 Clause 5.1.2.
Safety PLC program monitoring conveyor belt guard positions, emergency stops, and light curtains. Functional safety application.

[Assistant] Content: Company-internal standard operating procedures supplement the international standards for the ConveyorGuard Safety Interlock System 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 Conveyor Safety Interlock Software development team.


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

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

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

[Assistant]
Description: A deterministic safe-state transition shall be triggered by any detected critical fault condition in the PainScale Digital Assessment Tool, with all active outputs brought to a known safe configuration.
Rationale: A deterministic safe-state transition prevents the Pain Assessment Tool from operating in an unknown or hazardous state after a detected fault.
Priority: Mandatory
Acceptance Criterion: Safe state transition completes within the specified time limit for each defined critical fault, verified by fault injection during operation.
Source: Risk control


[System] You are an IEC 62304 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 VentAssist Pro (ICU ventilator controller, Class C):

"Software development follows IEC 62304 Clause 7.5 requirements for continuous monitoring."

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


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

[User]
Write a FMEA section on risk control verification for MindCalm Meditation Timer, a Class A Meditation Wellness App. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Mobile app providing guided meditation timers with optional heart rate display during sessions. Heart rate shown for interest only, not diagnostic.

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


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

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

"Maintenance activities follow IEC 62304:2020 Clause 6."

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

[User]
Expand requirement SRS-PERF-001: "end-to-end processing latency" (Category: performance)
Project: FridgeGuard Temperature Logger | Cold Chain Temperature Logger | Class A
Continuous logging and display of storage temperatures for compliance documentation. Firmware logging refrigerator temperatures for vaccine and medication cold chain compliance. Records and displays data, no alerts that drive clinical decisions.

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

[Assistant]
Description: End-to-end latency from DS18B20 temperature sensor data acquisition to output presentation shall not exceed the specified limit under normal operating conditions.
Rationale: Bounded processing latency ensures the Cold Chain Temperature Logger provides readings reflecting the current state without clinically significant delay.
Priority: Mandatory
Acceptance Criterion: Worst-case latency measured under maximum load conditions does not exceed the specified absolute maximum.
Source: System requirement


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

[User]
Write a SDP section on cybersecurity and health IT standards for GlucoSpot Continuous Glucose Display, a Class B CGM Display App. Reference IEC 62304 Clause 5.1.2.
Mobile app receiving and displaying continuous glucose monitor readings via BLE. Shows trends, time-in-range, and configurable glucose alerts.

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


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

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

"The lifecycle processes for the NeuroStim Programmer comply with IEC 62304-6."

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


[System] You are 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 data paths and processing pipeline for BalanceBoard Vestibular Trainer, a Class B Balance Training Platform Firmware. Reference IEC 62304 Clauses 5.3.1, 5.3.2.
Force plate firmware measuring center-of-pressure excursions during balance exercises. Provides real-time visual biofeedback.

[Assistant] Content: Data flows through the BalanceBoard Vestibular Trainer in a defined pipeline: 4x load cells data is acquired, validated, processed through the algorithm chain, and presented via USB. Each data transformation step has defined input and output formats per Clause 5.3.2, forming the basis for integration test cases.


[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 ConveyorGuard Safety Interlock System, a Class A Conveyor Safety Interlock Software. Reference IEC 62304 Clause 5.2.2.
Safety PLC program monitoring conveyor belt guard positions, emergency stops, and light curtains. Functional safety application.

[Assistant] Content: Data processing requirements for the ConveyorGuard Safety Interlock System define the transformations applied to raw input from guard position switches to produce the output presented to the user. Each transformation has defined accuracy bounds and error handling behavior specific to the Conveyor Safety Interlock Software operational context.


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

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

"Verification planning for the MedInventory scopes testing to system level only, consistent with Class A requirements. The verification plan references Clause 5.7 and defines acceptance criteria for each software requirement. Code coverage analysis is not required and is not included in the plan."

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


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

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

"The NurseCall Hub software development conforms to IEC 62304:2022, with risk management per ISO 14971:2019."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304:2022" which is incorrect. No 2022 edition exists. Current: IEC 62304:2006+AMD1:2015. All references must be corrected.


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

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

"The NurseCall Hub addresses IEC 62304 Clause 9.9 for continuous monitoring and Clause 10.1 for deployment validation."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 9.9 and 10.1, neither of which exists. Clause 9 has 9.1 through 9.8 only. IEC 62304 has no Clause 10. Standard ends at Clause 9. All clause references must be corrected.


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

[User]
Expand requirement SRS-PERF-001: "measurement accuracy specification" (Category: performance)
Project: VitalPulse SpO2 Monitor | Pulse Oximeter Firmware | Class B
Continuous monitoring of blood oxygen saturation and pulse rate with clinical alarms. Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

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

[Assistant]
Description: Output accuracy of the Pulse Oximeter Firmware shall meet or exceed the specified tolerance for all measurement parameters across operating conditions.
Rationale: Inaccurate output from the Pulse Oximeter Firmware could lead to incorrect clinical actions, making accuracy a safety-critical requirement.
Priority: Mandatory
Acceptance Criterion: Accuracy verified against a calibrated reference across the full measurement range, with all readings within tolerance for 200+ test points.
Source: Regulatory


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

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

"Configuration management for the NeuroStim Programmer follows Clause 8. Configuration items are identified per Clause 8.1.1, SOUP is identified per Clause 8.1.2, and change control is managed per Clause 8.2. Status accounting is maintained per Clause 8.3."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the NeuroStim Programmer (neurostimulator programmer, Class C). Standards references are accurate.


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

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

"Architectural design follows IEC 62304:2022 Clause 5.3 for Class B devices."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304:2022" which is incorrect. No 2022 edition exists. Current: IEC 62304:2006+AMD1:2015. All references must be corrected.


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

[User]
Write a SRS section on resource constraints and scalability for AirSentry Urban Air Quality Station, a Class A Air Quality Monitoring Station Firmware. Reference IEC 62304 Clause 5.2.2.
IoT firmware for urban air quality monitoring stations measuring PM2.5, NO2, O3, and CO. Publishes data to public API.

[Assistant] Content: The AirSentry Urban Air Quality Station resource constraints are derived from the ESP32 + Raspberry Pi hardware capabilities. Requirements specify headroom margins for memory and processing to ensure the Air Quality Monitoring Station Firmware remains stable under sustained operation during Continuous measurement and public reporting of urban air quality parameters.


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

[User]
Write a SDP section on development tools and tool qualification for Class A for VitalBoard Patient Summary, a Class A Patient Summary Dashboard. Reference IEC 62304 Clause 5.1.4.
Dashboard displaying patient vital signs history retrieved from the EMR. View-only with no alerting or trend analysis.

[Assistant] Content: The VitalBoard Patient Summary is developed in TypeScript/Angular targeting the Web SPA platform. Source code is maintained under version control with branching and tagging conventions defined in SOP-012. For the Class A Patient Summary Dashboard, formal tool qualification is not required per IEC 62304; however, the development toolchain is verified to function correctly through routine build-and-test cycles.


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

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

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

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


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

[User]
Expand requirement SRS-PERF-002: "resource utilization limits" (Category: performance)
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 shall operate within the specified RAM and flash memory budget on the Web SPA platform, including all runtime allocations.
Rationale: Memory constraints are fixed by the Web SPA hardware and must be respected to prevent resource exhaustion during operation.
Priority: Mandatory
Acceptance Criterion: Peak RAM usage during worst-case scenario does not exceed the specified limit, with minimum margin remaining.
Source: System requirement


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

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

"System testing for the SleepWell 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 sleep quality display app."

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


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

[User]
Write a SDP section on risk control verification and traceability for LabView Results Portal, a Class A Laboratory Results Viewer. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Web application displaying laboratory test results retrieved from the hospital LIS. Read-only viewer with no result interpretation or flagging.

[Assistant] Content: Verification of risk controls for the LabView Results Portal follows Clause 7.3.1. Each control implemented in software has a corresponding test case that demonstrates the hazardous condition is mitigated. Traceability records per Clause 7.3.2 document the chain from hazard through requirement to verification evidence.


[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 FetalGuard Heart Rate Monitor, a Class B Fetal Heart Rate Monitor Firmware. Reference IEC 62304 Clauses 7.1, 7.1.1.
External fetal heart rate monitor firmware using Doppler ultrasound. Displays fetal heart rate and variability during labor.

[Assistant] Content: The FetalGuard Heart Rate Monitor risk management process is concurrent with development, not sequential. Software causes of hazardous situations are identified per Clause 7.1 and documented per Clause 7.1.4. Risk controls are implemented as software requirements and verified through the applicable testing levels for the Fetal Heart Rate Monitor Firmware.


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

[User]
Write a SDP section on SOUP identification and management for MindCalm Meditation Timer, a Class A Meditation Wellness App. Reference IEC 62304 Clause 8.1.2.
Mobile app providing guided meditation timers with optional heart rate display during sessions. Heart rate shown for interest only, not diagnostic.

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


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

[User]
Write a SRS section on external system communication requirements 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: The TriageAI Emergency Triage Assistant communicates with external systems via EMR integration via FHIR. Requirements specify authentication, data encryption, message integrity verification, and timeout handling. The ED Triage Decision Support App must continue safe operation if the external system is unavailable.


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

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

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

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

"Software safety classification is performed per applicable regulatory requirements. The classification drives appropriate lifecycle activities and documentation."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "generic phrasing" 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 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

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

"SOUP management follows applicable guidance and industry conventions. Third-party components are evaluated per best practices for the pacemaker programmer."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "best practices", "applicable guidance", "industry conventions" provide no project-specific information about the PacePilot pacemaker programmer. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


[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] Does IEC 62304-3 exist?

[Assistant] No. IEC 62304 has no Part 3 or any sub-parts. It is a single-part standard.


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

[User]
Write a SRS section on data processing and transformation requirements for RespiRate Respiratory Monitor, a Class B Respiratory Rate Monitor Firmware. Reference IEC 62304 Clause 5.2.2.
Wearable firmware monitoring respiratory rate via chest impedance. Displays rate and alerts on bradypnea/tachypnea.

[Assistant] Content: The RespiRate Respiratory Monitor data pipeline requirements specify end-to-end data flow from bio-impedance electrodes through processing to output on I2C AFE. Requirements include input validation, range checking, unit conversion, and output formatting for Continuous respiratory rate monitoring with alarm generation for abnormal rates.


[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 failure mode identification approach for AirSentry Urban Air Quality Station, a Class A Air Quality Monitoring Station Firmware. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
IoT firmware for urban air quality monitoring stations measuring PM2.5, NO2, O3, and CO. Publishes data to public API.

[Assistant] Content: The AirSentry Urban Air Quality Station failure mode identification per Clause 7.1.2 uses a function-by-function analysis of the Air Quality Monitoring Station Firmware. Each software function is examined for potential failure modes: omission, commission, early, late, and value errors. Potential causes per Clause 7.1.2 include design defects, SOUP anomalies per Clause 7.1.3, and environmental factors.


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

[User]
Expand requirement SRS-FUNC-005: "device configuration management" (Category: functional)
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 allow authorized users to configure operating parameters via WebRTC and persist settings across power cycles.
Rationale: Configurable parameters allow the Remote Rehabilitation Platform to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: All configurable parameters persist correctly across power cycles and reject out-of-range values with appropriate error messages.
Source: User need


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

[User]
Write a SAD section on architecture verification scope for SleepScore Apnea Screening Tool, a Class B Sleep Apnea Screening App. Reference IEC 62304 Clauses 5.3.1, 5.3.6.
Mobile app analyzing overnight audio recordings to screen for obstructive sleep apnea indicators. Screening only, not diagnostic.

[Assistant] Content: Verification of the SleepScore Apnea Screening Tool architecture per Clause 5.3.6 is a phase gate requirement. The review confirms completeness of requirements coverage, correctness of interface definitions, and adequate risk control implementation in the Sleep Apnea Screening App design.


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

[User]
Expand requirement SRS-PERF-001: "memory usage budget" (Category: performance)
Project: TrainCert Staff Certification Tracker | Training Certification System | Class A
Tracking and reporting on staff training certifications and renewals. Web app tracking staff training certifications and renewal dates. Administrative HR tool for compliance tracking.

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: Peak memory consumption of the Training Certification System shall not exceed the allocated budget, with sufficient margin for stack overflow protection.
Rationale: Memory constraints are fixed by the Web application hardware and must be respected to prevent resource exhaustion during operation.
Priority: Mandatory
Acceptance Criterion: Memory profiling under stress conditions shows stable allocation with no leaks over a 72-hour test period.
Source: System requirement


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

[User]
Write a SDP section on primary international standards applicable to development for DreamLog Sleep Monitor, a Class A Sleep Tracking Display App. Reference IEC 62304 Clause 5.1.2.
Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

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


[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):

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

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


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

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

"The software is released. The release is documented. The release is verified. The release package is prepared. The release is approved. The AutoDose TPN software release follows the process."

[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 AutoDose TPN.


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

[User]
Expand requirement SRS-INTF-004: "clinical system integration interface" (Category: interface)
Project: AutoHUD Heads-Up Display Controller | Automotive HUD Controller Firmware | Class A
Rendering critical driving information on a windshield heads-up display. Firmware rendering vehicle speed, navigation, and ADAS warnings on a windshield-projected heads-up 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: The AutoHUD Heads-Up Display Controller shall exchange data with external systems via CAN bus using the specified message format with error handling.
Rationale: External system connectivity is required for the Automotive HUD Controller Firmware to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


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

[User]
Write a SDP section on problem reporting and investigation for WeatherNode Microclimate Station, a Class A Weather Station Firmware. Reference IEC 62304 Clauses 9.1, 9.2.
Solar-powered weather station firmware measuring temperature, humidity, wind, rainfall, and barometric pressure.

[Assistant] Content: The WeatherNode Microclimate Station problem reporting process per Clause 9.1 captures all software anomalies with sufficient detail for reproduction and root cause investigation. Clause 9.2 investigation assesses whether the problem represents a safety risk, determines the affected scope within the Weather Station Firmware, and identifies the corrective action required.


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

[User]
Write a SDP section on change control process for FallRisk Inpatient Assessment Tool, a Class B Fall Risk Assessment App. Reference IEC 62304 Clauses 8.2, 8.2.1.
Web app calculating fall risk scores for inpatients based on mobility, medication, and cognitive assessments.

[Assistant] Content: Change control for the FallRisk Inpatient Assessment Tool Fall Risk Assessment App follows Clause 8.2. Each change request is assessed for safety impact, assigned a priority, and tracked to closure. Changes to safety-related requirements or risk control measures require re-evaluation of the ISO 14971 risk analysis before implementation.


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

[User]
Write a SDP section on safety classification process and documentation for ScreenFlow Population Health Screener, a Class A Serverless Population Health Screening SaMD. Reference IEC 62304 Clause 4.3.
Serverless cloud application processing population-level health screening questionnaires and flagging individuals for follow-up based on risk scoring algorithms.

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


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

[User]
Expand requirement SRS-FUNC-003: "measurement data archival" (Category: functional)
Project: PostureGuard Desk Monitor | Posture Wellness Display Software | Class A
Visual feedback on desk posture for personal wellness awareness. USB webcam software that estimates sitting posture and displays a wellness score. No ergonomic prescriptions or clinical assessments.

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 PostureGuard Desk Monitor shall log measurement data with timestamps to non-volatile storage and provide a mechanism to retrieve logged data via USB 2.0.
Rationale: Persistent measurement records enable post-hoc analysis and meet regulatory requirements for data retention.
Priority: Desirable
Acceptance Criterion: Logged data is retrievable after power cycle, with all timestamps accurate to within 1 second of the reference clock.
Source: User need


[System] You are 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):

"Compliance with IEC 62304 Clause Annex A.1 (operational qualification) and Clause 5.5.2.1 (deployment validation) is demonstrated."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses Annex A.1 and 5.5.2.1, neither of which exists. IEC 62304 annexes are informative, not cited as requirements. IEC 62304 has no four-level numbering. All clause 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 configuration identification approach for SunGuard UV Index Display, a Class A UV Exposure Display Firmware. Reference IEC 62304 Clauses 8.1, 8.1.1.
Wearable UV index monitor with an OLED display showing current UV exposure level. Informational only, no sunburn prevention claims.

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


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

[User]
Write a SDP section on development methodology for Class A for FleetTrack GPS Tracking Module, a Class A Fleet GPS Tracking Firmware. Reference IEC 62304 Clause 5.1.1.
Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

[Assistant] Content: Development of the FleetTrack GPS Tracking Module 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 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):

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

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


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

[User]
Write a SDP section on hazard identification for the specific device for FallRisk Inpatient Assessment Tool, a Class B Fall Risk Assessment App. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Web app calculating fall risk scores for inpatients based on mobility, medication, and cognitive assessments.

[Assistant] Content: The FallRisk Inpatient Assessment Tool risk analysis per Clause 7.1.2 identifies software causes of hazardous situations specific to the Fall Risk Assessment App: data path corruption, timing violations, resource exhaustion, and incorrect state transitions. Each cause is linked to a risk control measure per Clause 7.2.1 and implemented as a verifiable software requirement.


[System] You are 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 AssetTrack Equipment Inventory, a Class A Equipment Inventory System. Reference IEC 62304 Clauses 7.1, 7.1.1.
Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management only.

[Assistant] Content: The AssetTrack Equipment Inventory risk management process is concurrent with development, not sequential. Software causes of hazardous situations are identified per Clause 7.1 and documented per Clause 7.1.4. Risk controls are implemented as software requirements and verified through the applicable testing levels for the Equipment Inventory 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 FetaSound (fetal heart rate monitor, Class B):

"This plan is prepared in compliance with IEC 62304-5 and ISO 13485:2016."

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


[System] You are 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-001: "continuous data sampling from primary sensor" (Category: functional)
Project: AutoclaveLog Cycle Recorder | Sterilization Cycle Data Logger | Class A
Recording and reporting autoclave sterilization cycle parameters. PC software recording autoclave cycle data (time, temperature, pressure) and generating compliance reports.

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

[Assistant]
Description: The AutoclaveLog Cycle Recorder shall continuously sample primary sensor data, buffer readings in memory, and pass validated samples to the processing module without data loss.
Rationale: Continuous data acquisition from the primary sensor is the fundamental input for Recording and reporting autoclave sterilization cycle parameters.
Priority: Mandatory
Acceptance Criterion: Verified by test: software acquires sensor data continuously for 60 minutes without data loss, confirmed by comparing acquisition count against expected count at the configured sampling rate.
Source: System requirement


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

[User]
Write a SDP section on cybersecurity and health IT standards for WasteTrack Biohazard Logger, a Class A Biohazard Waste Tracking App. Reference IEC 62304 Clause 5.1.2.
Mobile app scanning and logging biohazard waste container pickups. Tracks chain of custody for environmental compliance.

[Assistant] Content: Security controls for the WasteTrack Biohazard Logger are derived from IEC 81001-5-1:2021, which mandates a security risk management process parallel to the ISO 14971 safety risk process. IEC 82304-1:2016 is applied where the Biohazard Waste Tracking App runs on general-purpose computing platforms outside the manufacturer's direct hardware 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 OxyPure Controller (oxygen concentrator controller, Class C):

"The software architecture is designed following best engineering practices. Modules are structured to support maintainability and extensibility as needed."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as needed" provide no project-specific information about the OxyPure Controller oxygen concentrator controller. 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 purpose and scope for Class A with minimal documentation for CleanRoom Particle Counter Logger, a Class A Cleanroom Environmental Logger. Reference IEC 62304 Clause 5.1.1.
Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

[Assistant] Content: The scope of this plan covers the full software lifecycle of the CleanRoom Particle Counter Logger, a Cleanroom Environmental Logger classified as Safety Class A under IEC 62304 Clause 4.3. Because the software cannot contribute to a hazardous situation, the plan omits detailed design documentation (Clause 5.4), unit verification (Clause 5.5), and integration testing (Clause 5.6), concentrating instead on system-level activities that confirm the Cleanroom Environmental Logger meets its specified requirements.


[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 platform and build infrastructure for CardioRhythm ECG Analyzer, a Class B Single-Lead ECG Device Firmware. Reference IEC 62304 Clause 5.1.4.
Portable ECG device firmware acquiring single-lead ECG and classifying basic rhythm types. Incorrect classification could delay diagnosis.

[Assistant] Content: The CardioRhythm ECG Analyzer build environment uses C (embedded) on STM32L4+. Continuous integration builds execute on every commit, ensuring early detection of compilation errors and regression failures. Toolchain versions are locked to the configuration baseline and recorded in the Software Configuration Management Plan.


[System] You are a regulatory 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 ConsentView Informed Consent Archive, a Class A Consent Document Viewer. Reference IEC 62304 Clause 5.1.1.
Web portal for patients and staff to view signed informed consent documents. Read-only document viewer.

[Assistant] Content: Development of the ConsentView Informed Consent Archive 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 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):

"Post-market activities are conducted as required by applicable regulations. Feedback mechanisms are established per best practices for the BloodBank Manager."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "best practices", "as required by" 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. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-FUNC-005: "initialization integrity checks" (Category: functional)
Project: BreathEasy Air Quality Display | Environmental Air Quality Display | Class A
Informational display of indoor air quality metrics for general awareness. Indoor air quality monitor displaying PM2.5, CO2, and temperature on an LCD. Informational display only with no clinical guidance.

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

[Assistant]
Description: A power-on self-test shall validate SCD41 CO2 sensor communication, memory integrity, and I2C connectivity before the Environmental Air Quality Display transitions to its operational state.
Rationale: A power-on self-test confirms hardware and software readiness before the Environmental Air Quality Display 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 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):

"Formal design reviews with independent reviewers are conducted at each phase gate for the PillRemind. Review findings are tracked to closure."

[Assistant]
Verdict: FAIL
Note: Content mandates formal design reviews with independent reviewers for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Independent review is required only for Class C.


[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):

"REQ-SRS-056: Upon detecting a communication timeout with the sensor module, the OxyPure Controller shall display a warning indicator within 1 second and log the event. Acceptance criterion: simulate timeout and verify warning display timing and log entry. Priority: Mandatory. Source: Risk control."

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


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

[User]
Write a SRS section on user interaction requirements for FridgeGuard Temperature Logger, a Class A Cold Chain Temperature Logger. Reference IEC 62304 Clause 5.2.2.
Firmware logging refrigerator temperatures for vaccine and medication cold chain compliance. Records and displays data, no alerts that drive clinical decisions.

[Assistant] Content: The FridgeGuard Temperature Logger Cold Chain Temperature Logger presents information to the user via 1-Wire 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 minimal deliverables list for Class A for FleetTrack GPS Tracking Module, a Class A Fleet GPS Tracking Firmware. Reference IEC 62304 Clause 5.1.8.
Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

[Assistant] Content: Documentation planning per Clause 5.1.8 for the FleetTrack GPS Tracking Module yields a minimal Class A deliverable set: SDP, SRS, system test plan, system test report, software release record, and risk management file. Deliverables associated with architectural design, detailed design, unit testing, and integration testing are excluded.