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

[User]
Expand requirement SRS-FUNC-003: "data acquisition from primary sensor" (Category: functional)
Project: TriagePro Emergency Scoring App | Emergency Department Triage SaMD | Class B
Guiding emergency department triage scoring using the Manchester Triage System protocol. Standalone tablet app implementing Manchester Triage System scoring. Guides clinicians through triage flowchart and records patient acuity level.

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

[Assistant]
Description: Data from the primary sensor shall be acquired by the TriagePro Emergency Scoring App at the configured rate, with each sample timestamped and queued for processing.
Rationale: Reliable sensor data capture underpins all downstream processing and clinical output of the Emergency Department Triage SaMD.
Priority: Mandatory
Acceptance Criterion: Verified by test: software acquires sensor data continuously for 60 minutes without data loss, confirmed by comparing acquisition count against expected count at the configured sampling rate.
Source: System requirement


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

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

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

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


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

[User]
Write a SRS section on resource constraints and scalability for WaterPure Quality Logger, a Class A Water Quality Data Logger. Reference IEC 62304 Clause 5.2.2.
Embedded system logging purified water system parameters (conductivity, TOC, flow rate) for pharmaceutical manufacturing compliance.

[Assistant] Content: Computational resource requirements for the WaterPure Quality Logger define the maximum CPU utilization, RAM consumption, and flash/disk usage permitted on PLC with HMI. The Water Quality Data Logger must meet all functional and timing requirements within these resource envelopes.


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

[User]
Write a FMEA section on risk control verification for HomeVent BiPAP Controller, a Class C BiPAP Device Firmware. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Home bilevel positive airway pressure device firmware. Manages inspiratory/expiratory pressure, leak compensation, and patient triggering.

[Assistant] Content: The HomeVent BiPAP Controller risk control verification per Clause 7.3.1 exercises each control measure in isolation and in the context of the complete BiPAP Device Firmware. Clause 7.3.3 documentation records the verification method, the test result, and the conclusion regarding the control's effectiveness.


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

[User]
Expand requirement SRS-DATA-002: "record keeping duration" (Category: data)
Project: CogniTest Cognitive Assessment App | Cognitive Assessment Application | Class B
Administering and scoring standardized cognitive screening tests for clinical neuropsychological assessment. Tablet app administering standardized cognitive screening tests and scoring results. Used by neuropsychologists in clinical settings.

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

[Assistant]
Description: Measurement records stored by the Cognitive Assessment Application shall be maintained for the configured retention period before eligible for overwrite.
Rationale: Data retention supports clinical trend analysis and regulatory requirements for record keeping associated with the Cognitive Assessment Application.
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 ArthroNav (surgical navigation system, Class C):

"All verification for the surgical navigation system follows IEC 62304-5 requirements."

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


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

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

"Release activities follow standard practices to ensure quality and traceability. The release package is prepared as needed for regulatory submission."

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


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

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

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

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


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

[User]
Write a SDP section on development methodology for Class A for MedImage PACS Viewer, a Class A Web PACS Image Viewer. Reference IEC 62304 Clause 5.1.1.
Web-based PACS viewer enabling radiologists to review DICOM images with standard tools (windowing, measurement, MPR). View-only, no AI or diagnostic processing.

[Assistant] Content: The MedImage PACS Viewer follows an agile-inspired iterative lifecycle with lightweight phase gates suited to Class A software. Milestones are Requirements Baseline, Implementation Freeze, and System Test Complete. No architecture review or detailed design review gate is required, as these artifacts are not mandated 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 SDP section on risk control requirements traceability for PulmoCheck Spirometry Analyzer, a Class B Spirometry Analysis Software. Reference IEC 62304 Clause 5.2.3.
Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

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


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

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

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

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


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

[User]
Write a SDP section on development tools and tool qualification for Class A for FactoryTemp Industrial Temperature Monitor, a Class A Industrial Temperature Monitoring Firmware. Reference IEC 62304 Clause 5.1.4.
Firmware monitoring factory floor temperatures from distributed thermocouple arrays. Logs data for process control compliance.

[Assistant] Content: Development of the FactoryTemp Industrial Temperature Monitor uses C (embedded) on PLC (Allen-Bradley). Build automation ensures reproducible compilation, and all toolchain versions are recorded as part of the configuration management baseline. Given the Class A classification, no formal tool qualification report is produced; tool defects are handled through the standard problem resolution process.


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

[User]
Write a THREAT section on threat model data flow decomposition for BSACalc Body Surface Area Tool, a Class B BSA Calculator Web App. Reference IEC 62304 Clause 5.2.2.
Web calculator for body surface area using Mosteller and DuBois formulas. Used for chemotherapy dose calculations.

[Assistant] Content: Data flow decomposition for the BSACalc Body Surface Area Tool threat model identifies all pathways where data crosses trust boundaries in the BSA Calculator Web App. Each crossing point -- input from external sensors, output to display systems, and communication with remote services via REST API -- is analyzed for security threats.


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

[User]
Write a SDP section on development tools and tool qualification for Class A for DreamLog Sleep Monitor, a Class A Sleep Tracking Display App. Reference IEC 62304 Clause 5.1.4.
Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

[Assistant] Content: Development of the DreamLog Sleep Monitor uses React Native on iOS/Android. Build automation ensures reproducible compilation, and all toolchain versions are recorded as part of the configuration management baseline. Given the Class A classification, no formal tool qualification report is produced; tool defects are handled through the standard problem resolution process.


[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 safety requirements for Class B for WeightAlert Neonatal Scale, a Class B Neonatal Scale Firmware. Reference IEC 62304 Clauses 5.2.2, 5.2.3.
Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

[Assistant] Content: The WeightAlert Neonatal Scale Class B safety requirements include controls for data integrity, range validation, and fail-safe behavior when external system communication is lost. Each requirement traces to a hazard identified in the risk analysis and is verified during integration or system testing of the Neonatal Scale Firmware.


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

[User]
Write a SDP section on risk control verification and traceability for FleetTrack GPS Tracking Module, a Class A Fleet GPS Tracking Firmware. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

[Assistant] Content: Risk control verification for the FleetTrack GPS Tracking Module per Clause 7.3.1 is performed as part of the applicable testing levels. Each risk control measure is traced per Clause 7.3.2 from the ISO 14971 risk analysis through the SRS to the test result confirming its implementation in the Fleet GPS Tracking 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 SDP section on internal SOPs and procedures for GasMonitor Anesthetic Gas Logger, a Class A Anesthetic Gas Concentration Logger. Reference IEC 62304 Clause 5.1.2.
Software logging waste anesthetic gas concentrations in operating rooms for occupational safety compliance. Recording only.

[Assistant] Content: Work instructions for the GasMonitor Anesthetic Gas Logger 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 Anesthetic Gas Concentration Logger.


[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 BeamPlan Radiation Treatment Planner, a Class C Radiation Treatment Planning Software. Reference IEC 62304 Clauses 5.3.1, 5.3.6.
Desktop software calculating radiation treatment plans including beam angles, dose distribution, and organ-at-risk constraints.

[Assistant] Content: Architecture verification for the BeamPlan Radiation Treatment Planner per Clause 5.3.6 confirms traceability from requirements to architectural elements, adequacy of interface definitions, and correct implementation of risk control measures in the Radiation Treatment Planning Software design.


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

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

"The NeuroStim Programmer configuration management plan identifies all configuration items per Clause 8.1.1. SOUP items are tracked per Clause 8.1.2. Change control follows Clause 8.2 with traceability per Clause 8.2.4. Configuration status accounting is maintained per Clause 8.3."

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


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

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

"The StepTrack 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 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 DoseLog Radiation Badge Reader, a Class A Dosimetry Data Logger. Reference IEC 62304 Clause 5.2.2.
Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

[Assistant] Content: Baseline security requirements for the DoseLog Radiation Badge Reader ensure the Dosimetry Data Logger protects user data, resists unauthorized access, and maintains audit trails. Data communicated via database is encrypted. Access is controlled through authentication mechanisms appropriate to the deployment environment.


[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):

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

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


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

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

"Documentation is prepared in accordance with standard templates and guidelines. Review cycles are established at appropriate intervals for the wellness pedometer app."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "appropriate intervals" provide no project-specific information about the StepTrack wellness pedometer app. Content must reference specific IEC 62304 clauses, concrete activities, and measurable 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-SAFE-001: "Class A scope validation" (Category: safety)
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: The Water Quality Data Logger software functions are limited to informational display and data presentation, with no capability to influence clinical decisions or therapeutic actions.
Rationale: The Class A classification of the Water Quality Data Logger depends on the software having no path to contribute to a hazardous situation.
Priority: Mandatory
Acceptance Criterion: Code review confirms no software path exists that controls therapeutic outputs, modifies diagnostic results, or generates clinical alerts.
Source: Regulatory


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

[User]
Write a SDP section on scope boundaries of the software system for RetinaScan Diabetic Retinopathy Screener, a Class B Retinal Screening Software. Reference IEC 62304 Clauses 5.1.1, 5.1.2.
Desktop software analyzing retinal fundus images to detect signs of diabetic retinopathy for ophthalmologist review.

[Assistant] Content: The RetinaScan Diabetic Retinopathy Screener software boundary includes the application firmware, configuration data, and all SOUP components deployed on Windows desktop with GPU. Hardware components, operating system kernels supplied by the platform vendor, and remote services accessed via desktop GUI are excluded from the software lifecycle activities defined here, though their influence on software behavior is addressed in the risk analysis.


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

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

"The BloodBank Manager addresses IEC 62304 Clause 11.1 for continuous monitoring and Clause 5.0 for post-market surveillance."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 11.1 and 5.0, neither of which exists. IEC 62304 has no Clause 11. Clause 5 starts at 5.1. All clause references must be corrected.


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

[User]
Write a SDP section on development platform and build infrastructure for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clause 5.1.4.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: Development infrastructure for the CochleaMap CI Fitting Software includes a C++/Qt toolchain, automated build and test pipelines, and version control for all source and configuration files. The Cochlear Implant Fitting Software targets Windows desktop, and the build system produces identical outputs for a given source revision, supporting the reproducibility requirements of Clause 5.8.3.


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

[User]
Write a THREAT section on system description for threat modeling for InsuPrecise Insulin Pump Controller, a Class C Insulin Pump Controller Firmware. Reference IEC 62304 Clause 5.2.1.
Embedded firmware controlling insulin delivery in a patch-type insulin pump. Incorrect dosing could cause severe hypoglycemia or diabetic ketoacidosis.

[Assistant] Content: Threat modeling for the InsuPrecise Insulin Pump Controller begins with a system description identifying entry points, data stores, and trust boundaries of the Insulin Pump Controller Firmware. The model covers the ARM Cortex-M33 (TrustZone) execution environment, all BLE 5.0 to companion app, motor driver SPI interfaces, and persistent data stores.


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

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


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

[User]
Review this documentation excerpt for the InfuSafe Controller (insulin infusion pump controller, Class C):

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

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


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

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

"Software problem resolution follows ISO 14971-2 Clause 9."

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

[User]
Write a FMEA section on documenting failure modes and their effects for SunGuard UV Index Display, a Class A UV Exposure Display Firmware. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
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 FMEA documents each failure mode per Clause 7.1.4, providing sufficient detail for risk evaluation: the software function affected, the failure mode, the cause(s), the effect on the UV Exposure Display Firmware output, and the resulting hazard severity. This documentation is maintained in the 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 ThermoGuard (body temperature logger, Class A):

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

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


[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 external system communication requirements 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 communicates with external systems via physician web portal. Requirements specify authentication, data encryption, message integrity verification, and timeout handling. The Hybrid CGM Edge-Cloud Platform must continue safe operation if the external system is unavailable.


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

[User]
Write a SDP section on milestones and phase transition criteria for PharmLog Medication History Viewer, a Class A Medication History Viewer. Reference IEC 62304 Clause 5.1.1.
Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

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


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

[User]
Write a TRACE section on traceability scope including risk controls for PulmoCheck Spirometry Analyzer, a Class B Spirometry Analysis Software. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

[Assistant] Content: Traceability scope for the PulmoCheck Spirometry Analyzer 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 Spirometry Analysis Software.


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

[User]
Expand requirement SRS-FUNC-003: "differential pressure flow sensor data capture and buffering" (Category: functional)
Project: BreathSync ICU Ventilator Controller | ICU Ventilator Controller Software | Class C
Automated mechanical ventilation with multiple modes, alarm management, and patient synchronization. Software controlling an ICU mechanical ventilator with multiple ventilation modes (volume, pressure, SIMV). Failure could result in patient death.

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

[Assistant]
Description: The BreathSync ICU Ventilator Controller software shall acquire differential pressure flow sensor data at the specified sampling rate and store values in a circular buffer for processing by the ICU Ventilator Controller Software signal pipeline.
Rationale: Reliable sensor data capture underpins all downstream processing and clinical output of the ICU Ventilator Controller Software.
Priority: Mandatory
Acceptance Criterion: Verified by test: software acquires sensor data continuously for 60 minutes without data loss, confirmed by comparing acquisition count against expected count at the configured sampling rate.
Source: System requirement


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

[User]
Expand requirement SRS-FUNC-001: "continuous data sampling from primary sensor" (Category: functional)
Project: PharmaSafe CDSS | Clinical Decision Support System | Class B
Real-time clinical decision support for medication safety including interaction checking and dose validation. Clinical decision support system integrated into hospital EMR providing real-time drug-drug interaction alerts, allergy checking, and dosing guidance.

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

[Assistant]
Description: The PharmaSafe CDSS shall continuously sample primary sensor data, buffer readings in memory, and pass validated samples to the processing module without data loss.
Rationale: Reliable sensor data capture underpins all downstream processing and clinical output of the Clinical Decision Support System.
Priority: Mandatory
Acceptance Criterion: Verified by test: software acquires sensor data continuously for 60 minutes without data loss, confirmed by comparing acquisition count against expected count at the configured sampling rate.
Source: System requirement


[System] You are an IEC 62304 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 HeartLink (cardiac telemetry system, Class B):

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

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


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

[Assistant] Content: Baseline security requirements for the AnticoagCalc INR Dose Adjuster ensure the Anticoagulation Dosing Support Tool protects user data, resists unauthorized access, and maintains audit trails. Data communicated via web form is encrypted. Access is controlled through authentication mechanisms appropriate to the deployment environment.


[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 interface design between software items for DoseVerify In-Vivo Dosimetry System, a Class C In-Vivo Dosimetry Verification Software. Reference IEC 62304 Clause 5.3.2.
Software calculating real-time delivered dose from in-vivo dosimeter readings during radiation therapy. Dose verification for patient safety.

[Assistant] Content: Interfaces between DoseVerify In-Vivo Dosimetry System software items are specified per Clause 5.3.2 with defined data types, calling conventions, error return values, and thread safety requirements. The In-Vivo Dosimetry Verification Software internal interfaces include the MOSFET dosimeters abstraction layer, the processing API, and the presentation layer interface.


[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 AnticoagCalc INR Dose Adjuster, a Class B Anticoagulation Dosing Support Tool. Reference IEC 62304 Clause 5.1.2.
Web tool suggesting warfarin dose adjustments based on INR readings and patient history. Clinical decision support requiring physician review.

[Assistant] Content: The AnticoagCalc INR Dose Adjuster cybersecurity posture is defined per IEC 81001-5-1:2021, covering threat modeling, secure design, vulnerability management, and incident response for the Anticoagulation Dosing Support Tool. Health software product safety requirements from IEC 82304-1:2016 supplement the IEC 62304 lifecycle where applicable.


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

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

"The test strategy for the RadView DICOM is limited to system-level verification. All requirements from the SRS are covered by system test cases per Clause 5.7.1. Test failures are managed through the software problem resolution process (Clause 9). Unit and integration testing are out of scope for this Class A DICOM image viewer."

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


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

[User]
Write a SDP section on internal SOPs and procedures for AuditTrail QMS Event Logger, a Class A QMS Audit Trail Service. Reference IEC 62304 Clause 5.1.2.
Microservice capturing and storing quality management system audit events. Logging and reporting only.

[Assistant] Content: Work instructions for the AuditTrail QMS Event Logger 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 QMS Audit Trail Service.


[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):

"Software safety classification is performed per IEC 62304:2020 Clause 4.3."

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


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

[User]
Expand requirement SRS-SEC-001: "user identity verification" (Category: security)
Project: PulseRing Smart Ring Monitor | Wearable Smart Ring Firmware + Companion App | Class B
Continuous photoplethysmography-based heart rate and SpO2 monitoring via wearable ring with mobile companion. Wearable smart ring firmware measuring continuous PPG for heart rate and SpO2 with BLE streaming to companion mobile app for trend display.

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

[Assistant]
Description: The PulseRing Smart Ring Monitor shall require authentication before allowing modification of device configuration parameters via BLE 5.3.
Rationale: Access control prevents unauthorized modification of the Wearable Smart Ring Firmware + Companion App operating parameters.
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 THREAT section on STRIDE mitigations traced to requirements for GlucoSpot Continuous Glucose Display, a Class B CGM Display App. Reference IEC 62304 Clause 5.2.3.
Mobile app receiving and displaying continuous glucose monitor readings via BLE. Shows trends, time-in-range, and configurable glucose alerts.

[Assistant] Content: Threat-to-mitigation traceability for the GlucoSpot Continuous Glucose Display CGM Display App is maintained per Clause 5.2.3. Each STRIDE threat is mapped to a security requirement, an implementation, and a verification test. This traceability ensures no identified threat lacks a corresponding software control.


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

[User]
Review this documentation excerpt for the InfuSafe Controller (insulin infusion pump controller, Class C):

"The InfuSafe Controller detailed design per Clause 5.4 subdivides each software item into software units (Clause 5.4.1). Detailed design documents interfaces (Clause 5.4.3) and is verified per Clause 5.4.4 by reviewers independent of the author."

[Assistant]
Verdict: PASS
Note: Content includes detailed design per Clause 5.4 as required for Class C; correctly specifies independent review for Class C. Standards references are accurate.


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

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

"The LabView Portal 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 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):

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

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


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

[User]
Expand requirement SRS-FUNC-004: "startup diagnostic verification" (Category: functional)
Project: ChemoFlow Infusion Controller | Chemotherapy Infusion Pump Firmware | Class C
Precision-controlled chemotherapy drug infusion with dose-error detection and safety interlocks. Firmware for a chemotherapy infusion pump controlling precise drug delivery rates. Dosing errors could be life-threatening.

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

[Assistant]
Description: Upon power-up, the ChemoFlow Infusion Controller shall execute a self-test sequence verifying the integrity of the drop counting sensor interface, internal memory, and output subsystem before entering operational mode.
Rationale: A power-on self-test confirms hardware and software readiness before the Chemotherapy Infusion Pump Firmware begins use.
Priority: Mandatory
Acceptance Criterion: All fault injection scenarios are detected with 100% reliability across 50 test iterations.
Source: System requirement


[System] You are 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 SurgiPlan 3D Surgical Planner, a Class B 3D Surgical Planning SaMD. Reference IEC 62304 Clause 5.1.4.
Desktop SaMD for orthopedic surgeons to plan joint replacement procedures on 3D CT reconstructions. Outputs implant sizing and positioning specifications.

[Assistant] Content: Source code for the SurgiPlan 3D Surgical Planner 3D Surgical Planning SaMD is written in C++ (3D engine) + Python (UI) and compiled for Windows/macOS desktop with GPU. The build pipeline is automated and deterministic -- identical source revisions produce identical binaries. All build tool versions are captured in the configuration baseline per Clause 5.1.4.


[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: "audit trail and data export" (Category: functional)
Project: AllergyCard Patient Allergy Viewer | Patient Allergy Display | Class A
Read-only display of patient allergy information at point of care. Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

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 AllergyCard Patient Allergy Viewer shall log measurement data with timestamps to non-volatile storage and provide a mechanism to retrieve logged data via HL7 FHIR AllergyIntolerance API.
Rationale: Persistent measurement records enable post-hoc analysis and meet regulatory requirements for data retention.
Priority: Desirable
Acceptance Criterion: Logged data is retrievable after power cycle, with all timestamps accurate to within 1 second of the reference clock.
Source: User need


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

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

"REQ-SRS-045: The CardioPulse Monitor software shall provide a mechanism to export all configuration parameters to a structured file format. The export shall include version metadata. Acceptance criterion: exported file can be parsed and all parameters match the current configuration. Priority: Desirable. Source: User need."

[Assistant]
Verdict: PASS
Note: Content requirement is properly structured with measurable acceptance criteria. 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 ISO 14971-1 the correct reference for medical device compliance?

[Assistant] No. ISO 14971 is a single-part standard. There is no Part 1 designation. The correct citation is ISO 14971:2019.


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

[User]
Write a SRS section on data format and interoperability requirements for SurgLog Procedure Documentation App, a Class A Surgical Documentation App. Reference IEC 62304 Clause 5.2.2.
Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

[Assistant] Content: Data exchanged by the SurgLog Procedure Documentation App via REST API conforms to defined formats documented in this SRS. The Surgical Documentation App validates incoming data against the format specification and rejects malformed messages with a logged error. Output data formats are deterministic and reproducible.


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

[User]
Write a SDP section on Class C classification justification and implications for StrokeAlert CT Perfusion Analyzer, a Class C AI Stroke Triage CT Perfusion SaMD. Reference IEC 62304 Clause 4.3.
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: The StrokeAlert CT Perfusion Analyzer is classified as IEC 62304 Safety Class C per Clause 4.3, as malfunction of the AI Stroke Triage CT Perfusion SaMD could directly contribute to serious injury or death. The software controls critical therapeutic parameters and has no independent hardware safety mechanism that fully mitigates the risk. This classification mandates the most rigorous lifecycle activities including detailed design, unit verification with MC/DC coverage, integration testing, and independent review.


[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):

"The DialysisGuard software development plan addresses Clause 5.1 requirements. Planning includes risk management (Clause 5.1.7), documentation (Clause 5.1.8), and configuration management (Clause 5.1.9). The plan is kept updated per Clause 5.1.2."

[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 FetaSound (fetal heart rate monitor, Class B):

"Release activities follow standard practices to ensure quality and traceability. The release package is prepared as needed for regulatory submission."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as needed", "standard practices" provide no project-specific information about the FetaSound fetal heart rate monitor. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

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

"Compliance with IEC 62304 Clause 9.9 (deployment validation) and Clause 5.3.7 (automated regression testing) is demonstrated."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 9.9 and 5.3.7, neither of which exists. Clause 9 has 9.1 through 9.8 only. Clause 5.3 has 5.3.1 through 5.3.6 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 operational context and user population for DoseVerify In-Vivo Dosimetry System, a Class C In-Vivo Dosimetry Verification Software. Reference IEC 62304 Clause 5.2.2.
Software calculating real-time delivered dose from in-vivo dosimeter readings during radiation therapy. Dose verification for patient safety.

[Assistant] Content: This section describes the operational context of the DoseVerify In-Vivo Dosimetry System In-Vivo Dosimetry Verification Software. The system is intended for Real-time verification of delivered radiation dose using in-vivo dosimeter measurements during treatment, operating on Windows workstation. Key interfaces include electrometer readout, DICOM RT plan comparison, alarm output. These contextual factors drive the functional and non-functional requirements specified in subsequent sections.


[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):

"The ThermoGuard verification strategy addresses only system testing as mandated for Class A software per IEC 62304. Each software requirement has at least one corresponding system test case. No unit or integration testing is specified because Class A software cannot contribute to a hazardous situation."

[Assistant]
Verdict: PASS
Note: Content correctly limits Class A to system-level verification; risk management content follows ISO 14971 framework. Standards references are accurate.


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

[User]
Write a SRS section on requirements conventions and identification scheme for HydroRemind Hydration Tracker, a Class A Hydration Tracking Firmware. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

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


[System] You are 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 PacePilot (pacemaker programmer, Class C):

"The PacePilot development follows full Class C rigor: detailed design documentation, unit testing with coverage targets (statement 90%, branch 80%, MC/DC 80%), integration testing of all interfaces, system testing, and independent verification. All activities are traceable to requirements."

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


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

[User]
Write a SDP section on scope boundaries of the software system for InhaleSense Smart Inhaler Tracker, a Class A Smart Inhaler Adherence Tracker. Reference IEC 62304 Clauses 5.1.1, 5.1.2.
Firmware for a smart inhaler attachment detecting actuation events, tracking medication adherence, and syncing data to a mobile app and clinician portal.

[Assistant] Content: Scope is limited to the InhaleSense Smart Inhaler Tracker software items developed under this plan and released as a single configuration baseline. Peripherals, test jigs, and cloud infrastructure used during Detecting inhaler actuation events and tracking medication adherence for asthma management are addressed by separate system-level documentation and are not governed by IEC 62304 Clause 5.1.1 activities described herein.


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

[User]
Write a SDP section on problem reporting and investigation for RadView DICOM Viewer, a Class A Medical Image Viewer. Reference IEC 62304 Clauses 9.1, 9.2.
Desktop application for viewing DICOM medical images. Display-only with standard windowing controls. No CAD or diagnostic measurement tools.

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


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

[User]
Write a SRS section on resource constraints and scalability for SurgiPlan 3D Surgical Planner, a Class B 3D Surgical Planning SaMD. Reference IEC 62304 Clause 5.2.2.
Desktop SaMD for orthopedic surgeons to plan joint replacement procedures on 3D CT reconstructions. Outputs implant sizing and positioning specifications.

[Assistant] Content: Computational resource requirements for the SurgiPlan 3D Surgical Planner define the maximum CPU utilization, RAM consumption, and flash/disk usage permitted on Windows/macOS desktop with GPU. The 3D Surgical Planning SaMD must meet all functional and timing requirements within these resource envelopes.


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

[User]
Write a FMEA section on documenting failure modes and their effects for TeleRehab Remote Patient Monitor, a Class B Remote Rehabilitation Platform. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Platform enabling remote physiotherapy with video consultations and wearable sensor data streaming. Generates exercise adherence reports.

[Assistant] Content: The TeleRehab Remote Patient Monitor FMEA documents each failure mode per Clause 7.1.4, providing sufficient detail for risk evaluation: the software function affected, the failure mode, the cause(s), the effect on the Remote Rehabilitation Platform output, and the resulting hazard severity. This documentation is maintained in the 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 CaloriePal (nutrition tracking app, Class A):

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

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


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

[User]
Write a SDP section on development tools and tool qualification for Class A for WeatherNode Microclimate Station, a Class A Weather Station Firmware. Reference IEC 62304 Clause 5.1.4.
Solar-powered weather station firmware measuring temperature, humidity, wind, rainfall, and barometric pressure.

[Assistant] Content: For the Class A WeatherNode Microclimate Station, the development environment comprises C (embedded) with standard build tooling on STM32WL (LoRa SoC). All source artifacts are version-controlled. Formal tool validation is not required at this classification level; tool versions are recorded in the configuration baseline for reproducibility.


[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 documenting failure modes and their effects for WaveReview EEG Archive Viewer, a Class A EEG Archive Viewer. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Desktop application for reviewing archived EEG recordings. Playback and waveform display only, no seizure detection.

[Assistant] Content: The WaveReview EEG Archive Viewer FMEA documents each failure mode per Clause 7.1.4, providing sufficient detail for risk evaluation: the software function affected, the failure mode, the cause(s), the effect on the EEG Archive Viewer output, and the resulting hazard severity. This documentation is maintained in the risk management file.


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

[User]
Write a SRS section on system boundaries and external dependencies for MindCalm Meditation Timer, a Class A Meditation Wellness App. Reference IEC 62304 Clause 5.2.2.
Mobile app providing guided meditation timers with optional heart rate display during sessions. Heart rate shown for interest only, not diagnostic.

[Assistant] Content: The MindCalm Meditation Timer system overview identifies all external entities interacting with the Meditation Wellness App: input sources (external data), output destinations (HealthKit/Google Fit API), and the iOS/Android execution environment. Requirements for each external interface are documented in the interface requirements section.


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

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

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

[Assistant]
Verdict: PASS
Note: Content correctly limits Class A to system-level verification. 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 FetaSound (fetal heart rate monitor, Class B):

"The FetaSound conforms to IEC 62304:2006+AMD1:2015. Safety classification per Clause 4.3 designates this fetal heart rate monitor as Class B. Risk management follows ISO 14971:2019 with guidance from ISO/TR 24971:2020."

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


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

[User]
Write a TRACE section on gap identification and coverage analysis for PhysioTrack Rehabilitation Monitor, a Class B Physical Therapy Tracking System. Reference IEC 62304 Clause 5.7.4.
Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

[Assistant] Content: Coverage analysis for the PhysioTrack Rehabilitation Monitor per Clause 5.7.4 confirms that every SRS requirement maps to at least one test case with a passing result. Requirements implementing risk controls are additionally confirmed to have adequate test coverage. The Physical Therapy Tracking System release is contingent on 100% requirement coverage with no open gaps.


[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):

"Maintenance activities follow IEC 62304-6 Clause 6."

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


[System] You are 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 RetinaScan Pro (diabetic retinopathy screening AI, Class B):

"Maintenance planning for the RetinaScan Pro is established per Clause 6.1. Problem and modification analysis follows Clause 6.2. Modifications are implemented per Clause 6.3 using the established development processes."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the RetinaScan Pro (diabetic retinopathy screening AI, 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 OxyPure Controller (oxygen concentrator controller, Class C):

"The OxyPure Controller addresses IEC 62304 Clause 5.8.9 for performance benchmarking and Clause 11.1 for operational qualification."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.8.9 and 11.1, neither of which exists. Clause 5.8 has 5.8.1 through 5.8.8 only. IEC 62304 has no Clause 11. All clause 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 EchoAssist (echocardiogram analysis aid, Class B):

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

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


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

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

"The ThermoGuard test strategy is limited to system-level verification per Clause 5.7. Regression testing is performed when changes occur per Clause 5.7.3. Test record contents follow Clause 5.7.5. This is sufficient for Class A."

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

[User]
Expand requirement SRS-PERF-001: "data processing timing constraint" (Category: performance)
Project: PharmLog Medication History Viewer | Medication History Viewer | Class A
Read-only display of medication dispensing history. Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

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

[Assistant]
Description: End-to-end latency from primary sensor data acquisition to output presentation shall not exceed the specified limit under normal operating conditions.
Rationale: Real-time performance is critical for the Medication History Viewer 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 an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a FMEA section on failure mode identification approach for GrowthChart Pediatric Viewer, a Class A Growth Chart Display App. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Web app displaying pediatric growth charts with WHO/CDC percentile curves. Plots measurements, no diagnostic interpretation.

[Assistant] Content: The failure mode identification for the GrowthChart Pediatric Viewer Growth Chart Display App per Clause 7.1.2 considers every processing step from input to output. Failure categories include data corruption, computation error, timing fault, and communication loss. Each failure mode is linked to its potential causes, including SOUP defects evaluated per Clause 7.1.3.


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

[User]
Expand requirement SRS-FUNC-001: "audit trail and data export" (Category: functional)
Project: SleepScore Apnea Screening Tool | Sleep Apnea Screening App | Class B
Screening for sleep apnea indicators using smartphone audio analysis, requiring sleep study confirmation. Mobile app analyzing overnight audio recordings to screen for obstructive sleep apnea indicators. Screening only, not diagnostic.

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

[Assistant]
Description: All processed measurements shall be stored with timestamps in a persistent log accessible through audio API for clinical review and regulatory audit.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Sleep Apnea Screening App.
Priority: Desirable
Acceptance Criterion: Logged data is retrievable after power cycle, with all timestamps accurate to within 1 second of the reference clock.
Source: User need


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

[User]
Write a SDP section on development methodology for Class A for ClinTrial EDC Platform, a Class A Clinical Trial EDC Web Platform. Reference IEC 62304 Clause 5.1.1.
Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

[Assistant] Content: An iterative development approach with defined phase gates is adopted for the ClinTrial EDC Platform, appropriate for the Class A classification where system-level verification is the primary quality gate. Each iteration produces a testable increment of the Clinical Trial EDC Web Platform functionality, with reviews at Requirements Complete, Implementation Complete, and Release Readiness milestones.


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

[User]
Write a SDP section on internal SOPs and procedures for PowerTrack UPS Monitor, a Class A UPS Monitoring Software. Reference IEC 62304 Clause 5.1.2.
Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

[Assistant] Content: Work instructions for the PowerTrack UPS Monitor 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 UPS Monitoring Software.


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

[User]
Write a THREAT section on STRIDE threat categories applied to the device for BreathSync ICU Ventilator Controller, a Class C ICU Ventilator Controller Software. Reference IEC 62304 Clause 5.2.2.
Software controlling an ICU mechanical ventilator with multiple ventilation modes (volume, pressure, SIMV). Failure could result in patient death.

[Assistant] Content: The STRIDE analysis for the BreathSync ICU Ventilator Controller ICU Ventilator Controller Software evaluates six threat categories at each trust boundary: Spoofing (unauthorized entity impersonation), Tampering (data modification in transit or at rest), Repudiation (undetectable actions), Information Disclosure (data leakage), Denial of Service (availability disruption), and Elevation of Privilege (unauthorized capability access).


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

[User]
Write a SDP section on change control process for FactoryTemp Industrial Temperature Monitor, a Class A Industrial Temperature Monitoring Firmware. Reference IEC 62304 Clauses 8.2, 8.2.1.
Firmware monitoring factory floor temperatures from distributed thermocouple arrays. Logs data for process control compliance.

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


[System] You are a regulatory 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):

"Each LabView Portal module undergoes unit testing followed by integration testing. System testing validates end-to-end behavior. All results are independently reviewed."

[Assistant]
Verdict: FAIL
Note: Content mandates unit testing, integration testing, and independent review for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Clauses 5.5, 5.6, and independent review are not required for Class A.


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

[User]
Write a SDP section on requirements elicitation and documentation for PainScale Digital Assessment Tool, a Class B Pain Assessment Tool. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Web app for standardized pain assessment using validated scales (VAS, NRS, McGill). Records longitudinal pain data for treatment monitoring.

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


[System] You are 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 DoseCalc Medication Calculator, a Class B Medication Dose Calculator App. Reference IEC 62304 Clause 5.2.2.
Mobile app calculating medication doses based on patient weight, age, and renal function. Incorrect calculations could cause underdosing or adverse effects.

[Assistant] Content: The DoseCalc Medication Calculator data requirements define how the Medication Dose Calculator App stores, retrieves, and protects data acquired during Calculating weight-based medication doses for clinical prescribing support. Requirements specify data format, retention duration, backup frequency, and the behavior when data corruption is detected.


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

[User]
Write a SDP section on requirements verification approach for RemotICU Continuous Monitoring Hub, a Class B Edge-to-Cloud ICU Monitoring Gateway. Reference IEC 62304 Clause 5.2.6.
Edge gateway collecting data from bedside monitors (SpO2, HR, BP, ventilator) and streaming to cloud for trending, alerting, and tele-ICU review.

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


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

[User]
Write a SAD section on SOUP risk evaluation and anomaly management for FleetTrack GPS Tracking Module, a Class A Fleet GPS Tracking Firmware. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

[Assistant] Content: SOUP anomaly evaluation for the FleetTrack GPS Tracking Module per Clause 7.1.3 reviews published defect lists for each third-party component. Anomalies that could affect the Fleet GPS Tracking Firmware safety or functionality are documented in the risk management file with corresponding risk control measures.


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

[User]
Write a SRS section on sensor and communication protocol requirements for AIDose Chemotherapy Decision Support, a Class C Cloud AI Chemotherapy Dosing SaMD. Reference IEC 62304 Clause 5.2.2.
Cloud SaMD providing AI-driven chemotherapy dosing recommendations based on patient genomics, lab values, and treatment response data.

[Assistant] Content: Interface requirements for the AIDose Chemotherapy Decision Support specify the communication protocols, data formats, and timing constraints for each external interface of the Cloud AI Chemotherapy Dosing SaMD. The primary data acquisition interface uses HL7 FHIR R4 with specified data rates and error detection mechanisms.


[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 VitalBoard Patient Summary, a Class A Patient Summary Dashboard. Reference IEC 62304 Clause 5.2.2.
Dashboard displaying patient vital signs history retrieved from the EMR. View-only with no alerting or trend analysis.

[Assistant] Content: The VitalBoard Patient Summary Patient Summary Dashboard data requirements address storage, integrity, and lifecycle management. All persistent data is validated on read, and write operations use atomic commit mechanisms to prevent partial updates during Read-only display of patient vital sign history for clinical reference.


[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 DoseLog Radiation Badge Reader, a Class A Dosimetry Data Logger. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

[Assistant] Content: The DoseLog Radiation Badge Reader risk control verification per Clause 7.3.1 exercises each control measure in isolation and in the context of the complete Dosimetry Data Logger. Clause 7.3.3 documentation records the verification method, the test result, and the conclusion regarding the control's effectiveness.


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

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

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

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


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

[User]
Write a TRACE section on gap identification and coverage analysis for AuditTrail QMS Event Logger, a Class A QMS Audit Trail Service. Reference IEC 62304 Clause 5.7.4.
Microservice capturing and storing quality management system audit events. Logging and reporting only.

[Assistant] Content: The gap analysis for the AuditTrail QMS Event Logger identifies any software requirements without linked test cases, design elements without source requirements (orphan implementations), and test cases that do not trace to any requirement (unnecessary tests). All gaps are documented and resolved before the Release Readiness Review to confirm that the QMS Audit Trail Service verification is complete per Clause 5.7.4.


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

[User]
Write a SDP section on problem reporting and investigation for FridgeGuard Temperature Logger, a Class A Cold Chain Temperature Logger. Reference IEC 62304 Clauses 9.1, 9.2.
Firmware logging refrigerator temperatures for vaccine and medication cold chain compliance. Records and displays data, no alerts that drive clinical decisions.

[Assistant] Content: The problem resolution process for the FridgeGuard Temperature Logger follows Clauses 9.1 through 9.8. Each problem report is classified by severity, investigated for root cause, and resolved through the change control process. Records are maintained per Clause 9.5, and all resolutions are verified per Clause 9.7 before the Cold Chain Temperature Logger baseline is updated.


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

[User]
Expand requirement SRS-FUNC-001: "alarm generation and notification" (Category: functional)
Project: TriagePro Emergency Scoring App | Emergency Department Triage SaMD | Class B
Guiding emergency department triage scoring using the Manchester Triage System protocol. Standalone tablet app implementing Manchester Triage System scoring. Guides clinicians through triage flowchart and records patient acuity level.

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

[Assistant]
Description: The TriagePro Emergency Scoring App shall generate audible and visual alarms within the specified response time when a monitored parameter exceeds its configured threshold.
Rationale: Alarm functionality is a safety-critical feature of the Emergency Department Triage SaMD that directly supports clinical decision-making.
Priority: Mandatory
Acceptance Criterion: No alarm condition goes undetected across 200 simulated threshold exceedances with varying parameter values and crossing rates.
Source: Risk control