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

[User]
Write a SDP section on change control and trend analysis for problems for BalanceBoard Vestibular Trainer, a Class B Balance Training Platform Firmware. Reference IEC 62304 Clauses 9.4, 9.6.
Force plate firmware measuring center-of-pressure excursions during balance exercises. Provides real-time visual biofeedback.

[Assistant] Content: All BalanceBoard Vestibular Trainer problem corrections enter the change control process per Clause 9.4 before integration into the baseline. Trend analysis per Clause 9.6 tracks defect density, time-to-resolution, and defect category distribution across the Balance Training Platform Firmware development lifecycle to drive process improvement.


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

[User]
Expand requirement SRS-DATA-002: "measurement data lifecycle" (Category: data)
Project: RenalDose Renal Adjustment Calculator | Renal Dose Adjustment Calculator | Class B
Calculating renal-adjusted medication doses based on estimated glomerular filtration rate. Calculator adjusting medication doses for patients with impaired renal function based on eGFR.

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 RenalDose Renal Adjustment Calculator 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 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):

"The RadBeam Planner development follows IEC 62304-4 for the software lifecycle."

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


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

[User]
Write a SRS section on purpose of the SRS document for PulmoCheck Spirometry Analyzer, a Class B Spirometry Analysis Software. Reference IEC 62304 Clause 5.2.1.
Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

[Assistant] Content: The SRS for the PulmoCheck Spirometry Analyzer documents every functional, performance, interface, and safety requirement governing the Spirometry Analysis Software. Requirements originate from the system specification, the ISO 14971 risk analysis, and regulatory requirements. Traceability per Clause 5.2.1 links each requirement to its source and forward to its verification activity.


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

[User]
Write a SAD section on SOUP component integration and requirements for DermaLens Teledermatology Platform, a Class B Cloud Teledermatology SaMD. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Cloud platform enabling dermatologists to review patient-submitted skin images with AI-assisted triage scoring. Images uploaded from mobile app to cloud pipeline.

[Assistant] Content: The DermaLens Teledermatology Platform Cloud Teledermatology SaMD 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 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] List all valid IEC 62304 sub-clauses under Clause 7.3 and their subjects.

[Assistant]
IEC 62304 Clause 7.3 (Verification of risk control measures) contains the following sub-clauses:

- Clause 7.3: Verification of risk control measures
- Clause 7.3.1: Verify risk control measures
- Clause 7.3.2: Document traceability
- Clause 7.3.3: Document risk control measure verification

These are the only valid sub-clauses under 7.3. No additional sub-clauses exist.


[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 tool qualification for Class B and C for BreathSync ICU Ventilator Controller, a Class C ICU Ventilator Controller Software. Reference IEC 62304 Clause 5.1.4.
Software controlling an ICU mechanical ventilator with multiple ventilation modes (volume, pressure, SIMV). Failure could result in patient death.

[Assistant] Content: Tools used in verification of the BreathSync ICU Ventilator Controller undergo qualification per IEC 62304 Clause 5.1.4. This includes the C (embedded, MISRA C, IEC 62304 Class C) compiler, static analysis tools, and test execution frameworks. Qualification evidence demonstrates that each tool produces correct and repeatable results for the verification activities it supports.


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

[User]
Write a SDP section on scope boundaries of the software system for StrokeAlert CT Perfusion Analyzer, a Class C AI Stroke Triage CT Perfusion SaMD. Reference IEC 62304 Clauses 5.1.1, 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: This plan applies to all software executing within the StrokeAlert CT Perfusion Analyzer AI Stroke Triage CT Perfusion SaMD and its supporting build and verification infrastructure. External systems that exchange data with the AI Stroke Triage CT Perfusion SaMD via DICOM push from CT scanner are covered only at the interface boundary; their internal implementation is outside the scope of this SDP.


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

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

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

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


[System] You are a regulatory 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):

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

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


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

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

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

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


[System] You are 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):

"SOUP is identified for the MedInventory. SOUP anomaly lists are evaluated. SOUP is managed per the configuration management plan. SOUP items are documented. SOUP management follows IEC 62304."

[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 MedInventory.


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

[User]
Write a SDP section on scope boundaries of the software system for PathCloud AI Histology Analyzer, a Class B Cloud SaMD Histopathology Analysis Platform. Reference IEC 62304 Clauses 5.1.1, 5.1.2.
Cloud-hosted SaMD analyzing whole-slide histology images with deep learning to flag suspicious regions for pathologist review. Runs as a multi-tenant SaaS.

[Assistant] Content: This plan applies to all software executing within the PathCloud AI Histology Analyzer Cloud SaMD Histopathology Analysis Platform and its supporting build and verification infrastructure. External systems that exchange data with the Cloud SaMD Histopathology Analysis Platform via REST API are covered only at the interface boundary; their internal implementation is outside the scope of this SDP.


[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 ClinTrial EDC Platform, a Class A Clinical Trial EDC Web Platform. Reference IEC 62304 Clause 5.1.4.
Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

[Assistant] Content: The ClinTrial EDC Platform is developed in Python (Django) + TypeScript (React) targeting the AWS ECS + RDS PostgreSQL + S3 platform. Source code is maintained under version control with branching and tagging conventions defined in SOP-012. Build automation ensures reproducible compilation, and all toolchain versions are recorded as part of the configuration management baseline.


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

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

"As Class A software, the CaloriePal follows a streamlined verification approach. System tests are traced to software requirements and executed in the intended operating environment. Test records include pass/fail status, date, and tester identity per Clause 5.7.5. No code coverage metrics are mandated."

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

[User] Is IEC 62304:2015 the correct citation?

[Assistant] No. The correct citation is IEC 62304:2006+AMD1:2015. The base standard (IEC 62304:2006) was published in 2006. Amendment 1 was published in 2015, but it did not replace the base standard — it amended it. Citing 'IEC 62304:2015' alone is incorrect because it implies a standalone 2015 edition, which does not exist.


[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 DoseCalc Medication Calculator, a Class B Medication Dose Calculator App. Reference IEC 62304 Clauses 8.2, 8.2.1.
Mobile app calculating medication doses based on patient weight, age, and renal function. Incorrect calculations could cause underdosing or adverse effects.

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


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

[User]
Write a SDP section on verification strategy for Class C -- unit, integration, and system with coverage for CardioLoop Cardiac Resync Controller, a Class C CRT Optimization Firmware. Reference IEC 62304 Clauses 5.5, 5.5.2, 5.6, 5.7.
Firmware for cardiac resynchronization therapy devices optimizing biventricular pacing based on hemodynamic feedback.

[Assistant] Content: Class C verification of the CardioLoop Cardiac Resync Controller requires unit testing with statement coverage of at least 90%, branch coverage of at least 80%, and MC/DC coverage of at least 80% for safety-critical modules. Integration testing per Clause 5.6 verifies all inter-unit interfaces including RF telemetry, programmer interface. System-level verification per Clause 5.7 is performed by independent personnel not directly responsible for development.


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

[User]
Write a SAD section on architecture verification scope for NutriCalc TPN Formulation Tool, a Class B TPN Formulation Calculator. Reference IEC 62304 Clauses 5.3.1, 5.3.6.
Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

[Assistant] Content: The architecture described in this document is verified per Clause 5.3.6, confirming that all software requirements are addressed by at least one software item. Verification also confirms that the NutriCalc TPN Formulation Tool TPN Formulation Calculator architecture supports the defined interfaces and does not introduce new hazards.


[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 DialyFlow Dialysis Fluid Controller, a Class C Hemodialysis Fluid Controller Firmware. Reference IEC 62304 Clause 4.3.
Firmware controlling dialysate flow rates and composition in a hemodialysis machine. Fluid balance errors could be fatal.

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


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

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

"Software requirements for the LabView Portal are defined per Clause 5.2.1 and documented with the content required by Clause 5.2.2. Risk control measures are included in requirements per Clause 5.2.3. Requirements are verified per Clause 5.2.6."

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


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

[User]
Write a SAD section on purpose of the architecture document for RetinaStim Visual Prosthesis Controller, a Class C Retinal Prosthesis Controller Firmware. Reference IEC 62304 Clause 5.3.1.
Firmware driving a retinal implant electrode array based on camera input processing. Stimulation errors could cause retinal damage.

[Assistant] Content: The RetinaStim Visual Prosthesis Controller Software Architecture Document establishes the high-level design structure of the Retinal Prosthesis Controller Firmware per Clause 5.3.1. It defines the decomposition into software items, their interfaces, and the rationale for design decisions including technology choices and architectural patterns on Custom FPGA + ARM Cortex-M7.


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

[User]
Write a SDP section on milestones and phase transition criteria for DreamLog Sleep Monitor, a Class A Sleep Tracking Display App. Reference IEC 62304 Clause 5.1.1.
Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

[Assistant] Content: Transition between lifecycle phases requires completion of all phase-gate deliverables and sign-off by the designated reviewers. For the DreamLog Sleep Monitor project, key milestones include the Software Requirements Baseline (all requirements reviewed and traced to system requirements), the Design Freeze (architecture and interfaces finalized), and the Release Readiness Review (all verification complete and anomalies dispositioned).


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

[User]
Expand requirement SRS-FUNC-006: "user-configurable operating parameters" (Category: functional)
Project: AIDose Chemotherapy Decision Support | Cloud AI Chemotherapy Dosing SaMD | Class C
AI-generated chemotherapy dose adjustment recommendations based on patient-specific pharmacogenomic and clinical data. Cloud SaMD providing AI-driven chemotherapy dosing recommendations based on patient genomics, lab values, and treatment response data.

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

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


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

[User]
Expand requirement SRS-PERF-003: "output precision and accuracy" (Category: performance)
Project: ChestAI Pulmonary Nodule Detector | AI Pulmonary Nodule Detection SaMD | Class B
Computer-aided detection and measurement of pulmonary nodules on chest CT for radiologist review. Cloud AI SaMD analyzing chest CT scans to detect and measure pulmonary nodules, providing CAD overlay for radiologist review. FDA De Novo pathway.

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

[Assistant]
Description: Computational results produced by the ChestAI Pulmonary Nodule Detector shall be accurate to within the specified tolerance, validated against reference calculations.
Rationale: Inaccurate output from the AI Pulmonary Nodule Detection SaMD could lead to incorrect clinical actions, making accuracy a safety-critical requirement.
Priority: Mandatory
Acceptance Criterion: Statistical analysis of 500 measurements shows mean error within tolerance and standard deviation within specified limits.
Source: Regulatory


[System] You are 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 SleepScore Apnea Screening Tool, a Class B Sleep Apnea Screening App. Reference IEC 62304 Clause 5.1.2.
Mobile app analyzing overnight audio recordings to screen for obstructive sleep apnea indicators. Screening only, not diagnostic.

[Assistant] Content: Work instructions for the SleepScore Apnea Screening Tool 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 Sleep Apnea Screening 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 PillRemind (medication reminder app, Class A):

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

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "relevant standards", "established organizational procedures" provide no project-specific information about the PillRemind medication reminder app. 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 TRACE section on gap identification and coverage analysis for RetinaStim Visual Prosthesis Controller, a Class C Retinal Prosthesis Controller Firmware. Reference IEC 62304 Clause 5.7.4.
Firmware driving a retinal implant electrode array based on camera input processing. Stimulation errors could cause retinal damage.

[Assistant] Content: Gap analysis for the RetinaStim Visual Prosthesis Controller per Clause 5.7.4 examines the traceability matrix for completeness. Requirements without verification are flagged as critical gaps. Design elements without requirements are evaluated for removal or requirement creation. The Retinal Prosthesis Controller Firmware cannot be released until all gaps are resolved.


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

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

[Assistant] Content: The GlucoEdge Continuous Glucose Platform Hybrid CGM Edge-Cloud Platform implements security-in-depth: secure boot, runtime integrity monitoring, encrypted communications, and input validation on all external interfaces per IEC 81001-5-1:2021. Security testing covers penetration testing, fuzz testing of BLE 5.0 to phone, and vulnerability scanning.


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

[User]
Review this documentation excerpt for the HeartLink (cardiac telemetry system, Class B):

"Software release for the HeartLink follows Clause 5.8. Completeness is ensured per Clause 5.8.1, version identification per Clause 5.8.2, and known residual anomalies are documented per Clause 5.8.4 and evaluated per Clause 5.8.5."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the HeartLink (cardiac telemetry system, Class B). Standards references are accurate.


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

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

"The HydroLog addresses IEC 62304 Clause 5.10 (deployment validation) through formal review."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.10 which does not exist. Clause 5 ends at 5.8. The reference must be corrected to a valid clause number.


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

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

"Verification activities follow IEC 62304 Clause 5.4.5 for user acceptance testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.4.5 which does not exist. Clause 5.4 has 5.4.1 through 5.4.4 only. 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 SRS section on user interaction requirements for PulseRing Smart Ring Monitor, a Class B Wearable Smart Ring Firmware + Companion App. Reference IEC 62304 Clause 5.2.2.
Wearable smart ring firmware measuring continuous PPG for heart rate and SpO2 with BLE streaming to companion mobile app for trend display.

[Assistant] Content: The PulseRing Smart Ring Monitor user interaction requirements define the observable behavior of the Wearable Smart Ring Firmware + Companion App from the user's perspective. Requirements are organized by use scenario and specify the information displayed, the timing of updates, and the user actions supported during Continuous photoplethysmography-based heart rate and SpO2 monitoring via wearable ring with mobile companion.


[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 BeamPlan Radiation Treatment Planner, a Class C Radiation Treatment Planning Software. Reference IEC 62304 Clause 8.1.2.
Desktop software calculating radiation treatment plans including beam angles, dose distribution, and organ-at-risk constraints.

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


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

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

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

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


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

[User]
Expand requirement SRS-FUNC-005: "display update rate for Fall Risk Assessment App" (Category: functional)
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: Output presentation on the web form shall refresh at the configured interval, reflecting the most recent processed data from the Fall Risk Assessment App pipeline.
Rationale: Display freshness is critical for the Fall Risk Assessment App to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: End-to-end latency from data acquisition to display update does not exceed the specified limit for 99.9% of samples.
Source: User need


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

[User]
Write a SDP section on change control and trend analysis for problems for GlucoEdge Continuous Glucose Platform, a Class B Hybrid CGM Edge-Cloud Platform. Reference IEC 62304 Clauses 9.4, 9.6.
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: Problem resolution for the GlucoEdge Continuous Glucose Platform integrates with change control per Clause 9.4 -- every correction is implemented as a controlled change with impact assessment and regression testing. Trends per Clause 9.6 are evaluated quarterly and at release readiness to identify systemic quality issues in the Hybrid CGM Edge-Cloud Platform.


[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 lightweight review process for Class A for VitalBoard Patient Summary, a Class A Patient Summary Dashboard. Reference IEC 62304 Clause 5.1.1.
Dashboard displaying patient vital signs history retrieved from the EMR. View-only with no alerting or trend analysis.

[Assistant] Content: The VitalBoard Patient Summary SDP and its associated deliverables are reviewed by the project lead and quality assurance representative. Given the Class A classification, a lightweight review process is appropriate: the reviewer confirms that all required sections are addressed, requirements are traceable, and system-level verification is planned. No independent technical reviewer is required.


[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 AquaGuard Water Quality Monitor, a Class A Water Quality Monitoring Firmware. Reference IEC 62304 Clause 5.1.2.
Firmware for a multi-parameter water quality probe measuring pH, dissolved oxygen, conductivity, and turbidity in rivers and lakes.

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


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

[User]
Write a TRACE section on traceability scope including risk controls for NutriCalc TPN Formulation Tool, a Class B TPN Formulation Calculator. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

[Assistant] Content: Traceability scope for the NutriCalc TPN Formulation Tool includes both functional requirements and risk control measures. Risk control traceability per Clause 7.3.2 links each hazard cause to the software control, the SRS requirement, the implementation, and the verification evidence for the TPN Formulation Calculator.


[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 PaceSet Pacemaker Programmer, a Class C Cardiac Pacemaker Programmer Software. Reference IEC 62304 Clause 5.2.2.
Desktop software for interrogating and programming cardiac pacemakers via telemetry wand. Incorrect programming could cause pacing failure.

[Assistant] Content: The PaceSet Pacemaker Programmer data format requirements ensure interoperability with external systems connected via proprietary RF, USB. Data structures, encoding schemes, and byte ordering are fully specified. The Cardiac Pacemaker Programmer Software handles version mismatches in data formats gracefully.


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

[User]
Expand requirement SRS-SEC-001: "authentication for configuration access" (Category: security)
Project: WaterPure Quality Logger | Water Quality Data Logger | Class A
Continuous logging of purified water parameters for GMP compliance. Embedded system logging purified water system parameters (conductivity, TOC, flow rate) for pharmaceutical manufacturing compliance.

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

[Assistant]
Description: Access to configuration and administrative functions of the Water Quality Data Logger shall be restricted to authenticated and authorized users.
Rationale: Unauthorized configuration changes to the Water Quality Data Logger could compromise its intended function or patient safety.
Priority: Mandatory
Acceptance Criterion: Brute-force protection activates after the specified number of failed authentication attempts.
Source: Risk control


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

[User]
Write a FMEA section on risk control verification for NutriView Food Diary, a Class A Nutritional Tracking Display App. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Mobile app for manual food logging with nutritional summary display. No dietary recommendations or medical nutrition therapy.

[Assistant] Content: Verification of NutriView Food Diary 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 Nutritional Tracking Display App meets the risk acceptability criteria.


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

[User]
Expand requirement SRS-PERF-002: "data processing timing constraint" (Category: performance)
Project: CardioRhythm ECG Analyzer | Single-Lead ECG Device Firmware | Class B
Acquisition and preliminary rhythm classification of single-lead ECG for clinical screening. Portable ECG device firmware acquiring single-lead ECG and classifying basic rhythm types. Incorrect classification could delay diagnosis.

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

[Assistant]
Description: Processing latency of the Single-Lead ECG Device Firmware shall be bounded to ensure timely output that reflects current input conditions.
Rationale: Bounded processing latency ensures the Single-Lead ECG Device Firmware 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 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):

"The PacePilot addresses IEC 62304 Clause 6.4 (performance benchmarking) through formal review."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 6.4 which does not exist. Clause 6 has 6.1, 6.2, 6.3 only. The reference must be corrected to a valid clause number.


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

[User]
Write a TRACE section on traceability scope including risk controls for PedDose Pediatric Dosing App, a Class B Pediatric Dosing Calculator App. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Mobile reference app for pediatric drug dosing with weight-based calculations and age-specific ranges.

[Assistant] Content: The PedDose Pediatric Dosing App traceability matrix extends beyond functional requirements to include risk control traceability per Clause 7.3.2. Each risk control measure implemented in the Pediatric Dosing Calculator App software is traced from the ISO 14971 hazard through the software requirement to the verification test confirming its effectiveness.


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

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

"Risk management is performed. Risk analysis is conducted. Risk evaluation is completed. Risk control measures are implemented. Risk management activities are documented. The risk management process is followed."

[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 PacePilot.


[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 and trend analysis for problems for DialyFlow Dialysis Fluid Controller, a Class C Hemodialysis Fluid Controller Firmware. Reference IEC 62304 Clauses 9.4, 9.6.
Firmware controlling dialysate flow rates and composition in a hemodialysis machine. Fluid balance errors could be fatal.

[Assistant] Content: Corrections to the DialyFlow Dialysis Fluid Controller follow the change control process per Clause 9.4, with regression testing proportional to the scope of the change. Problem reports are periodically analyzed for trends per Clause 9.6 to identify systemic issues in the development process that might affect the quality of the Hemodialysis Fluid Controller Firmware.


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

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

"All verification for the hemodialysis machine controller follows IEC 62304:2020 requirements."

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

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

"Software safety classification is performed per IEC 62304-3 Clause 4.3."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304-3" which is incorrect. IEC 62304 has no Part 3. 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-DATA-002: "measurement record integrity" (Category: data)
Project: ChestAI Pulmonary Nodule Detector | AI Pulmonary Nodule Detection SaMD | Class B
Computer-aided detection and measurement of pulmonary nodules on chest CT for radiologist review. Cloud AI SaMD analyzing chest CT scans to detect and measure pulmonary nodules, providing CAD overlay for radiologist review. FDA De Novo pathway.

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

[Assistant]
Description: The ChestAI Pulmonary Nodule Detector shall validate the integrity of stored data using checksums, detecting and reporting any corruption of measurement records.
Rationale: Corrupted data must be identified to prevent clinical decisions based on unreliable measurements.
Priority: Mandatory
Acceptance Criterion: Integrity check correctly identifies all corrupted records with zero false positives on uncorrupted data.
Source: System requirement


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

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

"The LabView Portal integration plan defines incremental integration of all software units with interface testing at each step per Clause 5.6."

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


[System] You are 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] List all valid IEC 62304 sub-clauses under Clause 8.2 and their subjects.

[Assistant]
IEC 62304 Clause 8.2 (Change control) contains the following sub-clauses:

- Clause 8.2: Change control
- Clause 8.2.1: Approve change requests
- Clause 8.2.2: Implement change
- Clause 8.2.3: Verify change
- Clause 8.2.4: Provide means for traceability of change

These are the only valid sub-clauses under 8.2. No additional sub-clauses exist.


[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 external interface architecture for ThermoWatch Core Temperature Monitor, a Class B Core Temperature Monitor Firmware. Reference IEC 62304 Clause 5.3.2.
Continuous core temperature monitoring firmware using an ingestible sensor pill. Displays temperature trend with configurable alerts.

[Assistant] Content: The ThermoWatch Core Temperature Monitor architecture isolates external dependencies behind abstraction interfaces per Clause 5.3.2. The 433 MHz RF and LCD communication interfaces are accessed through adapter modules that translate protocol-specific details into the internal data model of the Core Temperature Monitor Firmware.


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

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

[Assistant] Content: System boundaries for the HandGrip Strength Dynamometer are defined at the software interface level. The Hand Dynamometer Firmware receives input from strain gauge load cell and produces output via BLE 5.0. Components beyond these interfaces are outside the scope of this SRS and are addressed in system-level documentation.


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

[User]
Write a SDP section on milestones and phase transition criteria for SurgLog Procedure Documentation App, a Class A Surgical Documentation App. Reference IEC 62304 Clause 5.1.1.
Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

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


[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):

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

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


[System] You are a regulatory 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):

"Integration testing validates the interaction between all NurseCall Hub software components."

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


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

[User]
Write a SRS section on data retention and integrity requirements for IncidentReport Clinical Event Logger, a Class A Incident Reporting System. Reference IEC 62304 Clause 5.2.2.
Web form for staff to submit clinical incident reports. Data entry and routing only, no analysis.

[Assistant] Content: Data requirements for the IncidentReport Clinical Event Logger specify retention periods, storage formats, and integrity controls for all persistent data managed by the Incident Reporting System. Data integrity is ensured through checksums or cryptographic hashes, and corrupted data is detected before use in any processing function.


[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 SunGuard UV Index Display, a Class A UV Exposure Display Firmware. Reference IEC 62304 Clauses 7.1, 7.1.1.
Wearable UV index monitor with an OLED display showing current UV exposure level. Informational only, no sunburn prevention claims.

[Assistant] Content: The SunGuard UV Index Display 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 UV Exposure Display Firmware.


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

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

"The PillRemind addresses IEC 62304 Clause 5.7.6 for data archival and Clause 5.1.12 for automated regression testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.7.6 and 5.1.12, neither of which exists. Clause 5.7 has 5.7.1 through 5.7.5 only. Clause 5.1 has 5.1.1 through 5.1.11 only. 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 SRS section on baseline security requirements for AutoHUD Heads-Up Display Controller, a Class A Automotive HUD Controller Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware rendering vehicle speed, navigation, and ADAS warnings on a windshield-projected heads-up display.

[Assistant] Content: The AutoHUD Heads-Up Display Controller Automotive HUD Controller Firmware implements security controls per IEC 81001-5-1:2021: user authentication, role-based access control, encrypted storage, encrypted communications, and event logging. Security requirements are verified through system testing and documented in the security test report.


[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 purpose of the architecture document for PaceSet Pacemaker Programmer, a Class C Cardiac Pacemaker Programmer Software. Reference IEC 62304 Clause 5.3.1.
Desktop software for interrogating and programming cardiac pacemakers via telemetry wand. Incorrect programming could cause pacing failure.

[Assistant] Content: This SAD transforms the PaceSet Pacemaker Programmer software requirements into a design architecture per Clause 5.3.1. The Cardiac Pacemaker Programmer Software is decomposed into software items with clearly defined boundaries, interfaces, and data flows, supporting both implementation and verification activities.


[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 PostureGuard Desk Monitor, a Class A Posture Wellness Display Software. Reference IEC 62304 Clause 5.2.2.
USB webcam software that estimates sitting posture and displays a wellness score. No ergonomic prescriptions or clinical assessments.

[Assistant] Content: Processing requirements for the PostureGuard Desk Monitor Posture Wellness Display Software cover data acquisition, filtering, computation, and presentation. Each processing step has specified input ranges, output tolerances, and error conditions. Data integrity is maintained throughout the processing pipeline.


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

[User]
Write a FMEA section on FMEA scope for Class A -- simplified analysis for SupplyChain Procurement Portal, a Class A Supply Chain Procurement System. Reference IEC 62304 Clause 7.1.1.
Web portal for ordering medical supplies with approval workflows. Procurement and logistics only.

[Assistant] Content: This simplified FMEA for the SupplyChain Procurement Portal Supply Chain Procurement System addresses Clause 7.1.1 by identifying software items that could contribute to hazardous situations. The analysis concludes that the Class A system has no failure modes leading to patient harm -- all failure effects are limited to degraded or absent informational display.


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

[User]
Write a SDP section on requirements elicitation and documentation for PharmaSafe CDSS, a Class B Clinical Decision Support System. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Clinical decision support system integrated into hospital EMR providing real-time drug-drug interaction alerts, allergy checking, and dosing guidance.

[Assistant] Content: Elicitation of requirements for the PharmaSafe CDSS follows Clause 5.2.1, drawing on system requirements, stakeholder interviews, and the risk management file. Requirements are documented with unique identifiers and classified by type: functional, performance, interface, or safety for the Clinical Decision Support System.


[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 GasMonitor Anesthetic Gas Logger, a Class A Anesthetic Gas Concentration Logger. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Software logging waste anesthetic gas concentrations in operating rooms for occupational safety compliance. Recording only.

[Assistant] Content: Risk control verification for the GasMonitor Anesthetic Gas Logger per Clause 7.3.1 confirms that each control is correctly implemented and effective. Test cases exercise the control under normal and boundary conditions. Verification evidence per Clause 7.3.3 links the test result to the risk control measure and the originating hazard in the Anesthetic Gas Concentration Logger risk management file.


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

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

"The DialysisGuard risk management file documents all identified hazards, estimated risks, implemented controls, and residual risk evaluations. Software-implemented controls are verified through targeted test cases. Verification records per Clause 7.3.3 confirm each control measure functions as intended."

[Assistant]
Verdict: PASS
Note: Content risk management content follows ISO 14971 framework. 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 RadView DICOM (DICOM image viewer, Class A):

"Verification for the RadView DICOM DICOM image viewer follows Clause 5.7 only. System tests exercise the software in its target configuration. Clause 5.5 unit verification and Clause 5.6 integration testing are explicitly excluded for Class A."

[Assistant]
Verdict: PASS
Note: Content correctly limits Class A to system-level verification; includes all required verification levels. 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 purpose of the SRS document for WasteTrack Biohazard Logger, a Class A Biohazard Waste Tracking App. Reference IEC 62304 Clause 5.2.1.
Mobile app scanning and logging biohazard waste container pickups. Tracks chain of custody for environmental compliance.

[Assistant] Content: This document specifies the software requirements for the WasteTrack Biohazard Logger Biohazard Waste Tracking App as required by IEC 62304 Clause 5.2.1. It serves as the primary input to design and the primary reference for verification test case derivation. All requirements are verifiable, traceable, and configuration-controlled.


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

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

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

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


[System] You are 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 ClinTrial EDC Platform, a Class A Clinical Trial EDC Web Platform. Reference IEC 62304 Clause 5.1.2.
Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

[Assistant] Content: Security controls for the ClinTrial EDC Platform 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 Clinical Trial EDC Web Platform runs on general-purpose computing platforms outside the manufacturer's direct hardware control.


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

[User]
Write a FMEA section on risk control verification for BalanceBoard Vestibular Trainer, a Class B Balance Training Platform Firmware. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Force plate firmware measuring center-of-pressure excursions during balance exercises. Provides real-time visual biofeedback.

[Assistant] Content: Verification of BalanceBoard Vestibular Trainer 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 Balance Training Platform Firmware meets the risk acceptability 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 VentAssist Pro (ICU ventilator controller, Class C):

"System testing for the VentAssist Pro establishes tests per Clause 5.7.1. The software problem resolution process is used per Clause 5.7.2. Retesting after changes follows Clause 5.7.3. Test records conform to Clause 5.7.5."

[Assistant]
Verdict: PASS
Note: Content limits verification to system testing per Clause 5.7. 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 lightweight review process for Class A for LabStream LIS Middleware, a Class A Laboratory Information Middleware. Reference IEC 62304 Clause 5.1.1.
Middleware software connecting laboratory analyzers to the hospital LIS. Routes results, applies auto-validation rules, and flags critical values.

[Assistant] Content: Review of LabStream LIS Middleware Class A deliverables consists of a peer review by the project lead and a quality check by the QA representative. The review confirms completeness of the SDP, traceability of requirements, and adequacy of the system test plan. Independent technical review is not required for the Laboratory Information Middleware at this classification level.


[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):

"Configuration management for the DialysisGuard 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 DialysisGuard (hemodialysis machine controller, 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 ThermoGuard (body temperature logger, Class A):

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

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the ThermoGuard (body temperature logger, Class A). 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 change control and trend analysis for problems for WoundTrack Healing Analyzer, a Class B Wound Assessment App. Reference IEC 62304 Clauses 9.4, 9.6.
Mobile app photographing wounds and measuring area/perimeter over time to track healing progress for clinician review.

[Assistant] Content: Problem resolution for the WoundTrack Healing Analyzer integrates with change control per Clause 9.4 -- every correction is implemented as a controlled change with impact assessment and regression testing. Trends per Clause 9.6 are evaluated quarterly and at release readiness to identify systemic quality issues in the Wound Assessment App.


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

[User]
Write a TRACE section on traceability scope including risk controls for HydroRemind Hydration Tracker, a Class A Hydration Tracking Firmware. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

[Assistant] Content: Traceability scope for the HydroRemind Hydration Tracker includes both functional requirements and risk control measures. Risk control traceability per Clause 7.3.2 links each hazard cause to the software control, the SRS requirement, the implementation, and the verification evidence for the Hydration Tracking Firmware.


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

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

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

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


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

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

"In accordance with ISO 14971-2, verification activities include system testing."

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


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

[User]
Write a SAD section on architectural overview for Class C with segregation for BrachyDose HDR Afterloader Controller, a Class C HDR Brachytherapy Afterloader Firmware. Reference IEC 62304 Clauses 5.3.1, 5.3.2, 5.3.5.
Firmware controlling high-dose-rate brachytherapy source positioning and dwell times. Source positioning errors cause lethal local radiation.

[Assistant] Content: The BrachyDose HDR Afterloader Controller HDR Brachytherapy Afterloader Firmware architecture implements segregation per Clause 5.3.5 to isolate safety-critical software items from non-safety items. The safety-critical path -- from source position encoder 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 a regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a THREAT section on threat model data flow decomposition for CardioLoop Cardiac Resync Controller, a Class C CRT Optimization Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware for cardiac resynchronization therapy devices optimizing biventricular pacing based on hemodynamic feedback.

[Assistant] Content: The CardioLoop Cardiac Resync Controller threat model decomposes the CRT Optimization Firmware into data flow diagrams showing all external entities, processes, data stores, and data flows. Each data flow crossing a trust boundary is analyzed for threats. The decomposition covers intracardiac impedance input, internal processing, and output via RF telemetry.


[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):

"The FetaSound risk management file documents all identified hazards, estimated risks, implemented controls, and residual risk evaluations. Software-implemented controls are verified through targeted test cases. Verification records per Clause 7.3.3 confirm each control measure functions as intended."

[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-INTF-002: "external system data exchange" (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: Interoperability enables integration of Automotive HUD Controller Firmware data into the clinical workflow and patient record.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


[System] You are a 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: "power-on self-test sequence" (Category: functional)
Project: AnesBot Automated Anesthesia Controller | Automated Anesthesia Delivery Software | Class C
Target-controlled propofol infusion guided by processed EEG depth-of-anesthesia monitoring. Software controlling target-controlled infusion of propofol based on BIS monitoring. Overdose could cause respiratory arrest.

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

[Assistant]
Description: A power-on self-test shall validate BIS module communication, memory integrity, and serial to BIS monitor connectivity before the Automated Anesthesia Delivery Software transitions to its operational state.
Rationale: Startup verification prevents the Automated Anesthesia Delivery Software from operating with undetected faults that could affect output accuracy.
Priority: Mandatory
Acceptance Criterion: Self-test completes within the specified startup time and correctly detects each of the following injected faults: sensor disconnection, memory corruption, and display failure.
Source: System requirement


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

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

"Software safety classification is performed per IEC 62304-1 Clause 4.3."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304-1" which is incorrect. IEC 62304 is a single-part standard. The correct citation is IEC 62304:2006+AMD1:2015. All references must be corrected.


[System] You are 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 InfuSafe Controller (insulin infusion pump controller, Class C):

"Software release for the InfuSafe Controller follows Clause 5.8. Completeness is ensured per Clause 5.8.1, version identification per Clause 5.8.2, and known residual anomalies are documented per Clause 5.8.4 and evaluated per Clause 5.8.5."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the InfuSafe Controller (insulin infusion pump controller, Class C). Standards references are accurate.


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

[User]
Expand requirement SRS-PERF-003: "real-time performance requirement" (Category: performance)
Project: GlucoEdge Continuous Glucose Platform | Hybrid CGM Edge-Cloud Platform | Class B
Continuous glucose monitoring with edge processing on wearable and cloud-based trend analysis for clinician review. Hybrid system: embedded BLE firmware on a wearable CGM patch streams readings to a phone app, which uploads to cloud for trend analysis and physician dashboard.

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

[Assistant]
Description: End-to-end latency from enzymatic glucose sensor data acquisition to output presentation shall not exceed the specified limit under normal operating conditions.
Rationale: Real-time performance is critical for the Hybrid CGM Edge-Cloud Platform to support timely clinical decisions based on current data.
Priority: Mandatory
Acceptance Criterion: End-to-end latency is within the specified limit for 99.9% of samples over a 24-hour test period.
Source: System requirement


[System] You are 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: FetalGuard Heart Rate Monitor | Fetal Heart Rate Monitor Firmware | Class B
Continuous external fetal heart rate monitoring during labor with clinical display. External fetal heart rate monitor firmware using Doppler ultrasound. Displays fetal heart rate and variability during labor.

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

[Assistant]
Description: Patient-identifiable data stored by the FetalGuard Heart Rate Monitor shall be encrypted at rest using a validated cryptographic algorithm with a key length of at least 256 bits.
Rationale: Data-at-rest encryption is required to meet privacy regulations and protect patient confidentiality.
Priority: Mandatory
Acceptance Criterion: Encrypted storage verified by reading raw storage media and confirming no patient-identifiable data is visible without the decryption key.
Source: Regulatory


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

[User]
Write a SRS section on data retention and integrity requirements for PulseRing Smart Ring Monitor, a Class B Wearable Smart Ring Firmware + Companion App. Reference IEC 62304 Clause 5.2.2.
Wearable smart ring firmware measuring continuous PPG for heart rate and SpO2 with BLE streaming to companion mobile app for trend display.

[Assistant] Content: Persistent data managed by the PulseRing Smart Ring Monitor includes configuration parameters, acquired measurements from PPG LED array (green + red + IR), and operational logs. Data integrity requirements specify error detection mechanisms and the Wearable Smart Ring Firmware + Companion App response to data corruption events.


[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-002: "execution monitoring and recovery" (Category: safety)
Project: AIDose Chemotherapy Decision Support | Cloud AI Chemotherapy Dosing SaMD | Class C
AI-generated chemotherapy dose adjustment recommendations based on patient-specific pharmacogenomic and clinical data. Cloud SaMD providing AI-driven chemotherapy dosing recommendations based on patient genomics, lab values, and treatment response data.

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

[Assistant]
Description: A dedicated watchdog timer shall monitor the AIDose Chemotherapy Decision Support execution and initiate a controlled restart if the main loop fails to complete within its timing window.
Rationale: Hardware-independent monitoring ensures that a frozen main processor cannot leave the Cloud AI Chemotherapy Dosing SaMD in an unsafe operating state.
Priority: Mandatory
Acceptance Criterion: Watchdog independence verified: main processor halt results in watchdog-initiated recovery within timing specification.
Source: Risk control


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

[User]
Expand requirement SRS-INTF-001: "primary sensor interface protocol" (Category: interface)
Project: PowerTrack UPS Monitor | UPS Monitoring Software | Class A
Logging and displaying UPS status for facility infrastructure monitoring. Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

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 PowerTrack UPS Monitor shall communicate with the primary sensor via SNMP, implementing error detection and recovery for communication failures.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the UPS Monitoring Software output.
Priority: Mandatory
Acceptance Criterion: Error injection tests confirm 100% detection rate for corrupted frames and recovery within specified timeout.
Source: System requirement


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

[User]
Expand requirement SRS-INTF-002: "data export and interoperability" (Category: interface)
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 Sterilization Cycle Data Logger shall support bidirectional data exchange with external systems over RS-232 serial.
Rationale: External system connectivity is required for the Sterilization Cycle Data Logger to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Format validation passes for all message types with correct field encoding verified.
Source: User need


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

[User]
Write a SRS section on functional requirements overview for WeightAlert Neonatal Scale, a Class B Neonatal Scale Firmware. Reference IEC 62304 Clause 5.2.2.
Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

[Assistant] Content: Functional requirements for the WeightAlert Neonatal Scale specify the data processing, user interaction, and output generation capabilities of the Neonatal Scale Firmware. Each requirement describes a discrete function the software shall perform during Precision weight measurement for neonatal patients with change-rate alerting, with acceptance criteria sufficient to derive verification test cases.


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

[User]
Write a SDP section on risk control requirements traceability for NeoVent Neonatal Ventilator, a Class C Neonatal Ventilator Firmware. Reference IEC 62304 Clause 5.2.3.
Neonatal ventilator firmware supporting CPAP, NIPPV, and conventional ventilation for extremely premature infants. Tidal volumes as low as 2 mL.

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


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

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

"In accordance with IEC 62304:2020, verification activities include system testing."

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


[System] You are a regulatory 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 purpose of the architecture document for GaitSense Walking Analysis, a Class B Gait Analysis Insole Firmware. Reference IEC 62304 Clause 5.3.1.
Instrumented insole firmware analyzing gait patterns and detecting asymmetries. Reports generated for orthopedic assessment.

[Assistant] Content: This Software Architecture Document describes the structural design of the GaitSense Walking Analysis, decomposing the Gait Analysis Insole Firmware into software items with defined interfaces and responsibilities per IEC 62304 Clause 5.3.1. The architecture addresses safety requirements, performance constraints, and integration needs identified in the SRS.


[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 FridgeGuard Temperature Logger, a Class A Cold Chain Temperature Logger. Reference IEC 62304 Clause 5.1.8.
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 documentation set is limited to the deliverables required for Class A: the SDP, SRS, system test records, software release record, and the risk management file. No architecture document, detailed design specification, unit test report, or integration test report is produced for this Cold Chain Temperature Logger.


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

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

"The CaloriePal development follows ISO 13485-2 for the software lifecycle."

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


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

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

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

[Assistant]
Description: Data integrity of all stored records in the Dosimetry Data Logger shall be verified using CRC or equivalent checksums upon read-back.
Rationale: Data integrity mechanisms ensure measurement records retrieved from the Dosimetry Data Logger are trustworthy for clinical review.
Priority: Mandatory
Acceptance Criterion: Integrity check correctly identifies all corrupted records with zero false positives on uncorrupted data.
Source: System requirement