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

[User]
Expand requirement SRS-PERF-001: "output precision and accuracy" (Category: performance)
Project: CochleaMap CI Fitting Software | Cochlear Implant Fitting Software | Class C
Programming electrode mapping and stimulation parameters for cochlear implant sound processors. Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

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

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


[System] You are 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 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: The SurgLog Procedure Documentation App communicates with external systems via speech-to-text API. Requirements specify authentication, data encryption, message integrity verification, and timeout handling. The Surgical Documentation App must continue safe operation if the external system is unavailable.


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

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

"SOUP functional requirements for the PillRemind are specified per Clause 5.3.3."

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


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

[User]
Write a FMEA section on FMEA scope for Class C -- comprehensive analysis for InsuPrecise Insulin Pump Controller, a Class C Insulin Pump Controller Firmware. Reference IEC 62304 Clause 7.1.1.
Embedded firmware controlling insulin delivery in a patch-type insulin pump. Incorrect dosing could cause severe hypoglycemia or diabetic ketoacidosis.

[Assistant] Content: Failure mode analysis for the Class C InsuPrecise Insulin Pump Controller examines every software item in the Insulin Pump Controller Firmware architecture for potential contributions to hazardous situations per Clause 7.1.1. The analysis assigns severity, probability, and detectability ratings to each failure mode. All failure modes with unacceptable risk have corresponding risk control measures traced to software requirements.


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

[User]
Write a SDP section on risk management integration into the lifecycle for ECGInsight Rhythm Interpreter, a Class B ECG Interpretation Service. Reference IEC 62304 Clauses 7.1, 7.1.1.
Cloud service analyzing 12-lead ECG recordings and generating preliminary rhythm interpretations for physician review.

[Assistant] Content: Software risk management activities are integrated throughout the ECGInsight Rhythm Interpreter development lifecycle in accordance with IEC 62304 Clause 7 and ISO 14971. Risk analysis begins during requirements analysis, with identified hazards traced through design, implementation, and verification to confirm that all risk control measures are effectively implemented and verified.


[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):

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

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


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

[User]
Write a SDP section on cybersecurity and health IT standards for VitalBoard Patient Summary, a Class A Patient Summary Dashboard. Reference IEC 62304 Clause 5.1.2.
Dashboard displaying patient vital signs history retrieved from the EMR. View-only with no alerting or trend analysis.

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


[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 ScreenFlow Population Health Screener, a Class A Serverless Population Health Screening SaMD. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Serverless cloud application processing population-level health screening questionnaires and flagging individuals for follow-up based on risk scoring algorithms.

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


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

[User]
Write a SRS section on data processing and transformation requirements for HomeVent BiPAP Controller, a Class C BiPAP Device Firmware. Reference IEC 62304 Clause 5.2.2.
Home bilevel positive airway pressure device firmware. Manages inspiratory/expiratory pressure, leak compensation, and patient triggering.

[Assistant] Content: Data processing requirements for the HomeVent BiPAP Controller define the transformations applied to raw input from flow sensor to produce the output presented to the user. Each transformation has defined accuracy bounds and error handling behavior specific to the BiPAP Device Firmware operational context.


[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 C with full V-model for AutoPancreas Closed-Loop Glucose Controller, a Class C Artificial Pancreas Controller Firmware. Reference IEC 62304 Clause 5.1.1.
Artificial pancreas firmware integrating CGM readings with insulin pump delivery using a PID control algorithm. Life-sustaining closed-loop system.

[Assistant] Content: Development of the AutoPancreas Closed-Loop Glucose Controller adheres to a V-model lifecycle with phase gates at every transition. Independent review is required at requirements baseline, architecture approval, detailed design approval, unit test completion, integration test completion, and system test completion. No phase gate can be passed without documented sign-off from a reviewer independent of the development team.


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

[User]
Write a SDP section on risk management integration into the lifecycle for NutriView Food Diary, a Class A Nutritional Tracking Display App. Reference IEC 62304 Clauses 7.1, 7.1.1.
Mobile app for manual food logging with nutritional summary display. No dietary recommendations or medical nutrition therapy.

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


[System] You are a regulatory 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):

"Per IEC 62304 Clause 7.1, risk analysis is performed. Per IEC 62304 Clause 7.1, hazards are identified. Per IEC 62304 Clause 7.1, causes are documented. Per IEC 62304 Clause 7.1, the CaloriePal risk analysis is complete."

[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 CaloriePal.


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

[User]
Write a SDP section on risk control requirements traceability for FactoryTemp Industrial Temperature Monitor, a Class A Industrial Temperature Monitoring Firmware. Reference IEC 62304 Clause 5.2.3.
Firmware monitoring factory floor temperatures from distributed thermocouple arrays. Logs data for process control compliance.

[Assistant] Content: Clause 5.2.3 requires that risk control measures implemented in the FactoryTemp Industrial Temperature Monitor software appear as traceable requirements. The traceability chain runs from the ISO 14971 hazard analysis to the SRS requirement to the test case verifying the control's effectiveness in the Industrial Temperature Monitoring 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 lightweight review process for Class A for WeatherNode Microclimate Station, a Class A Weather Station Firmware. Reference IEC 62304 Clause 5.1.1.
Solar-powered weather station firmware measuring temperature, humidity, wind, rainfall, and barometric pressure.

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


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

[User]
Write a FMEA section on risk control verification for GaitSense Walking Analysis, a Class B Gait Analysis Insole Firmware. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Instrumented insole firmware analyzing gait patterns and detecting asymmetries. Reports generated for orthopedic assessment.

[Assistant] Content: Risk control verification for the GaitSense Walking Analysis per Clause 7.3.1 confirms that each control is correctly implemented and effective. Test cases exercise the control under normal and boundary conditions. Verification evidence per Clause 7.3.3 links the test result to the risk control measure and the originating hazard in the Gait Analysis Insole Firmware risk management file.


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

[User]
Write a SDP section on change control and trend analysis for problems for WaterPure Quality Logger, a Class A Water Quality Data Logger. Reference IEC 62304 Clauses 9.4, 9.6.
Embedded system logging purified water system parameters (conductivity, TOC, flow rate) for pharmaceutical manufacturing compliance.

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


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

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

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

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


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

[User]
Write a SDP section on purpose and scope for Class A with minimal documentation for WaterPure Quality Logger, a Class A Water Quality Data Logger. Reference IEC 62304 Clause 5.1.1.
Embedded system logging purified water system parameters (conductivity, TOC, flow rate) for pharmaceutical manufacturing compliance.

[Assistant] Content: This Software Development Plan establishes the lifecycle framework for the WaterPure Quality Logger Water Quality Data Logger, defining all development activities, deliverables, and verification milestones in compliance with IEC 62304 Clause 5.1.1. As a Class A system that cannot contribute to a hazardous situation, the documentation scope is intentionally minimal, focusing on system-level verification and requirements traceability rather than detailed design or unit-level testing.


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

[User]
Expand requirement SRS-SAFE-001: "fault response and safe shutdown" (Category: safety)
Project: WeightAlert Neonatal Scale | Neonatal Scale Firmware | Class B
Precision weight measurement for neonatal patients with change-rate alerting. Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

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 Neonatal Scale Firmware shall enter a defined safe state within the maximum allowable transition time when a critical fault is detected, ensuring no hazardous output persists.
Rationale: A deterministic safe-state transition prevents the Neonatal Scale Firmware from operating in an unknown or hazardous state after a detected fault.
Priority: Mandatory
Acceptance Criterion: All 20 defined fault scenarios result in correct safe-state entry within timing limits across 10 iterations each.
Source: Risk control


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

[User]
Write a SRS section on functional requirements overview for StrokeAlert CT Perfusion Analyzer, a Class C AI Stroke Triage CT Perfusion SaMD. Reference IEC 62304 Clause 5.2.2.
Time-critical cloud SaMD processing CT perfusion scans to generate ischemic core and penumbra maps for acute stroke triage. Results pushed to mobile app within 5 minutes.

[Assistant] Content: This section specifies the functional behavior of the StrokeAlert CT Perfusion Analyzer AI Stroke Triage CT Perfusion SaMD. Requirements cover data input from external sources, processing algorithms, output generation via DICOM push from CT scanner, and user interaction patterns. All functional requirements are derived from the system specification or risk analysis.


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

[User]
Write a SRS section on functional requirements overview for AquaGuard Water Quality Monitor, a Class A Water Quality Monitoring Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware for a multi-parameter water quality probe measuring pH, dissolved oxygen, conductivity, and turbidity in rivers and lakes.

[Assistant] Content: The AquaGuard Water Quality Monitor functional requirements define what the Water Quality Monitoring Firmware does in response to user inputs, sensor data, and system events. Requirements are organized by functional area: data acquisition, signal processing, display and output, and system management. Each requirement is individually testable.


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

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

"Risk control measures are implemented per ISO 62304 Clause 7."

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


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

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

"Per IEC 62304 Clause 7.1, risk analysis is performed. Per IEC 62304 Clause 7.1, hazards are identified. Per IEC 62304 Clause 7.1, causes are documented. Per IEC 62304 Clause 7.1, the ChemoCalc risk analysis is complete."

[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 ChemoCalc.


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

[User]
Expand requirement SRS-DATA-002: "stored data corruption detection" (Category: data)
Project: ScheduleSync Appointment Manager | Appointment Scheduling System | Class A
Administrative scheduling and calendar management for clinical appointments. Web application for scheduling patient appointments across multiple clinics. Administrative scheduling only, no clinical workflow.

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 ScheduleSync Appointment Manager shall validate the integrity of stored data using checksums, detecting and reporting any corruption of measurement records.
Rationale: Corrupted data must be identified to prevent clinical decisions based on unreliable measurements.
Priority: Mandatory
Acceptance Criterion: Intentionally corrupted records are detected and flagged with 100% detection rate across 100 injected corruption events.
Source: System requirement


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

[User] Can I cite ISO 14971-1 in my documentation?

[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 resource constraints and scalability for HomeVent BiPAP Controller, a Class C BiPAP Device Firmware. Reference IEC 62304 Clause 5.2.2.
Home bilevel positive airway pressure device firmware. Manages inspiratory/expiratory pressure, leak compensation, and patient triggering.

[Assistant] Content: Resource requirements for the HomeVent BiPAP Controller specify maximum memory utilization, persistent storage consumption, and processor loading on ARM Cortex-M7. The BiPAP Device Firmware must operate within these constraints under worst-case conditions without degradation of safety-relevant functions.


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

[User]
Expand requirement SRS-DATA-001: "data integrity validation" (Category: data)
Project: ClinTrial EDC Platform | Clinical Trial EDC Web Platform | Class A
Electronic capture and management of clinical trial data across multiple investigator sites. Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

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

[Assistant]
Description: The ClinTrial EDC Platform shall detect corrupted measurement records through integrity checking and flag affected entries for review.
Rationale: Corrupted data must be identified to prevent clinical decisions based on unreliable measurements.
Priority: Mandatory
Acceptance Criterion: Intentionally corrupted records are detected and flagged with 100% detection rate across 100 injected corruption events.
Source: System requirement


[System] You are 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):

"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 LabView Portal read-only lab results viewer. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

[User]
Write a SRS section on resource constraints and scalability for InsuPrecise Insulin Pump Controller, a Class C Insulin Pump Controller Firmware. Reference IEC 62304 Clause 5.2.2.
Embedded firmware controlling insulin delivery in a patch-type insulin pump. Incorrect dosing could cause severe hypoglycemia or diabetic ketoacidosis.

[Assistant] Content: The InsuPrecise Insulin Pump Controller resource constraints are derived from the ARM Cortex-M33 (TrustZone) hardware capabilities. Requirements specify headroom margins for memory and processing to ensure the Insulin Pump Controller Firmware remains stable under sustained operation during Automated insulin delivery control with programmable basal rates and bolus calculations.


[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 sensor and communication protocol requirements for NeuroTune DBS Programmer, a Class C Deep Brain Stimulator Programmer App. Reference IEC 62304 Clause 5.2.2.
Tablet application programming deep brain stimulation implants for movement disorders. Stimulation parameter errors could cause neurological harm.

[Assistant] Content: External interface requirements for the NeuroTune DBS Programmer Deep Brain Stimulator Programmer App define the data exchanged across each interface boundary: BLE 5.0, tablet GUI. For each interface, requirements specify the protocol, data format, timing, and error recovery behavior.


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

[User]
Expand requirement SRS-PERF-001: "RAM and storage constraints" (Category: performance)
Project: ConveyorGuard Safety Interlock System | Conveyor Safety Interlock Software | Class A
Monitoring safety interlocks and emergency stops on industrial conveyor systems. Safety PLC program monitoring conveyor belt guard positions, emergency stops, and light curtains. Functional safety application.

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 ConveyorGuard Safety Interlock System memory footprint on Safety PLC (Siemens F-CPU) shall remain within specified limits under worst-case operational scenarios.
Rationale: Memory constraints are fixed by the Safety PLC (Siemens F-CPU) hardware and must be respected to prevent resource exhaustion during operation.
Priority: Mandatory
Acceptance Criterion: Peak RAM usage during worst-case scenario does not exceed the specified limit, with minimum margin remaining.
Source: System requirement


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

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

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

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


[System] You are 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):

"Compliance with IEC 62304 Clause 6.4 (data archival) and Clause 5.9 (user acceptance testing) is demonstrated."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 6.4 and 5.9, neither of which exists. Clause 6 has 6.1, 6.2, 6.3 only. Clause 5 ends at 5.8. All clause references must be corrected.


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

[User]
Write a SDP section on risk control verification and traceability for TeleRehab Remote Patient Monitor, a Class B Remote Rehabilitation Platform. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Platform enabling remote physiotherapy with video consultations and wearable sensor data streaming. Generates exercise adherence reports.

[Assistant] Content: The TeleRehab Remote Patient Monitor risk control traceability matrix per Clause 7.3.2 links every identified hazard cause to its software-implemented control and to the verification activity confirming its effectiveness. Clause 7.3.3 requires documentation of the verification results for each risk control measure applied to the Remote Rehabilitation Platform.


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

[User]
Write a SAD section on SOUP risk evaluation and anomaly management for AnticoagCalc INR Dose Adjuster, a Class B Anticoagulation Dosing Support Tool. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
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 SOUP risk assessment per Clause 7.1.3 documents all known SOUP defects relevant to the Anticoagulation Dosing Support Tool operational context. Where a SOUP defect could contribute to a hazardous situation, the architecture implements a software-level mitigation or the affected SOUP component is replaced.


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

[User]
Expand requirement SRS-PERF-003: "measurement accuracy specification" (Category: performance)
Project: CardioRhythm ECG Analyzer | Single-Lead ECG Device Firmware | Class B
Acquisition and preliminary rhythm classification of single-lead ECG for clinical screening. Portable ECG device firmware acquiring single-lead ECG and classifying basic rhythm types. Incorrect classification could delay diagnosis.

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

[Assistant]
Description: The CardioRhythm ECG Analyzer shall maintain measurement accuracy within the specified tolerance across the full operating range of the ADS1292R ECG AFE.
Rationale: Inaccurate output from the Single-Lead ECG Device Firmware could lead to incorrect clinical actions, making accuracy a safety-critical requirement.
Priority: Mandatory
Acceptance Criterion: Accuracy verified against a calibrated reference across the full measurement range, with all readings within tolerance for 200+ test points.
Source: Regulatory


[System] You are 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):

"Software problem resolution follows ISO 14901 Clause 9."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 14901" which is incorrect. ISO 14901 does not exist. The risk management standard is ISO 14971:2019. All references must be corrected.


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

[User]
Expand requirement SRS-FUNC-006: "initialization integrity checks" (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 startup sequence shall include diagnostic checks of all critical subsystems and report any detected faults before allowing operational use.
Rationale: Startup verification prevents the Emergency Department Triage SaMD from operating with undetected faults that could affect output accuracy.
Priority: Mandatory
Acceptance Criterion: Self-test completes within the specified startup time and correctly detects each of the following injected faults: sensor disconnection, memory corruption, and display failure.
Source: System requirement


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

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

"Software safety classification is performed per ISO 14901 Clause 4.3."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 14901" which is incorrect. ISO 14901 does not exist. The risk management standard is ISO 14971:2019. All references must be corrected.


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

[User]
Write a SRS section on purpose of the SRS document for RadOnco Cloud Treatment Planner, a Class C Cloud Radiation Treatment Planning SaMD. Reference IEC 62304 Clause 5.2.1.
Cloud-based radiation oncology treatment planning system using GPU clusters for Monte Carlo dose calculation. Treatment plans directly drive linear accelerator delivery.

[Assistant] Content: The SRS for the RadOnco Cloud Treatment Planner documents every functional, performance, interface, and safety requirement governing the Cloud Radiation Treatment Planning SaMD. Requirements originate from the system specification, the ISO 14971 risk analysis, and regulatory requirements. Traceability per Clause 5.2.1 links each requirement to its source and forward to its verification activity.


[System] You are 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):

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

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


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

[User]
Expand requirement SRS-PERF-001: "memory usage budget" (Category: performance)
Project: PressoTrack Blood Pressure Trending | Ambulatory Blood Pressure Monitor Firmware | Class B
Automated periodic blood pressure measurement and trending over 24 hours. Firmware for an automated blood pressure cuff that trends readings over 24 hours. Trending errors could mask hypertensive episodes.

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

[Assistant]
Description: Peak memory consumption of the Ambulatory Blood Pressure Monitor Firmware shall not exceed the allocated budget, with sufficient margin for stack overflow protection.
Rationale: Exceeding memory limits could cause undefined behavior in the Ambulatory Blood Pressure Monitor Firmware, potentially affecting safety.
Priority: Mandatory
Acceptance Criterion: Memory profiling under stress conditions shows stable allocation with no leaks over a 72-hour test period.
Source: System requirement


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

[User]
Write a FMEA section on risk control verification for CalibrationTracker Equipment Logger, a Class A Calibration Record System. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Web application tracking calibration dates and results for medical test equipment. Administrative record keeping.

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


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

[User]
Write a SRS section on data processing and transformation requirements for GasMonitor Anesthetic Gas Logger, a Class A Anesthetic Gas Concentration Logger. Reference IEC 62304 Clause 5.2.2.
Software logging waste anesthetic gas concentrations in operating rooms for occupational safety compliance. Recording only.

[Assistant] Content: Data processing requirements for the GasMonitor Anesthetic Gas Logger define the transformations applied to raw input from IR gas analyzer to produce the output presented to the user. Each transformation has defined accuracy bounds and error handling behavior specific to the Anesthetic Gas Concentration Logger operational context.


[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 ThermoWatch Core Temperature Monitor, a Class B Core Temperature Monitor Firmware. Reference IEC 62304 Clauses 7.3.1, 7.3.3.
Continuous core temperature monitoring firmware using an ingestible sensor pill. Displays temperature trend with configurable alerts.

[Assistant] Content: The ThermoWatch Core Temperature Monitor risk control verification per Clause 7.3.1 exercises each control measure in isolation and in the context of the complete Core Temperature Monitor 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 regulatory documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a SAD section on SOUP risk evaluation and anomaly management for CleanRoom Particle Counter Logger, a Class A Cleanroom Environmental Logger. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

[Assistant] Content: Risk evaluation of SOUP in the CleanRoom Particle Counter Logger follows Clause 7.1.3. Published anomaly lists are reviewed for each SOUP item deployed in the Cleanroom Environmental Logger. Anomalies relevant to Logging and displaying airborne particle counts for cleanroom compliance are entered into the risk management file, and mitigations are implemented where the residual risk is unacceptable.


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

[User]
Write a SDP section on risk control verification and traceability for InfuRate IV Flow Calculator, a Class B Infusion Rate Calculator. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Desktop calculator for IV infusion rates based on drug concentration, patient weight, and ordered dose. Clinical decision support tool.

[Assistant] Content: The InfuRate IV Flow Calculator risk control traceability matrix per Clause 7.3.2 links every identified hazard cause to its software-implemented control and to the verification activity confirming its effectiveness. Clause 7.3.3 requires documentation of the verification results for each risk control measure applied to the Infusion Rate Calculator.


[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):

"Software problem resolution follows IEC 62304-2 Clause 9."

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


[System] You are 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: SurgLog Procedure Documentation App | Surgical Documentation App | Class A
Documentation and review of surgical procedure notes. Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

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

[Assistant]
Description: User authentication shall be enforced for all configuration changes to the SurgLog Procedure Documentation App, with credential validation before granting access.
Rationale: Access control prevents unauthorized modification of the Surgical Documentation App operating parameters.
Priority: Mandatory
Acceptance Criterion: Configuration modification is rejected when attempted without valid credentials, verified across all configurable parameters.
Source: Risk control


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

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

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

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


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

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

"For the AutoDose TPN, ISO 14971:2019 risk management is integrated with the IEC 62304 software lifecycle. Risk control measures identified in the risk analysis are incorporated as software requirements per Clause 5.2.3. The medical device risk analysis is re-evaluated per Clause 5.2.4 after requirements changes."

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


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

[User]
Expand requirement SRS-PERF-003: "output precision and accuracy" (Category: performance)
Project: HemaCount Digital Cell Counter | IVD Digital Cell Counter Software | Class B
Automated white blood cell differential counting from digitized peripheral blood smear images. Desktop software performing automated differential white blood cell counting on digitized blood smear images using computer vision.

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

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


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

[User]
Write a TRACE section on risk control coverage verification for AirSentry Urban Air Quality Station, a Class A Air Quality Monitoring Station Firmware. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
IoT firmware for urban air quality monitoring stations measuring PM2.5, NO2, O3, and CO. Publishes data to public API.

[Assistant] Content: The AirSentry Urban Air Quality Station risk control gap analysis verifies end-to-end traceability per Clause 7.3.2: from hazard to risk control to software requirement to test case to test result. Gaps at any point in this chain prevent release of the Air Quality Monitoring Station Firmware until resolved. The analysis is documented as part of the Release Readiness Review evidence.


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

[User]
Write a SDP section on verification strategy for Class C -- unit, integration, and system with coverage for DialyFlow Dialysis Fluid Controller, a Class C Hemodialysis Fluid Controller Firmware. Reference IEC 62304 Clauses 5.5, 5.5.2, 5.6, 5.7.
Firmware controlling dialysate flow rates and composition in a hemodialysis machine. Fluid balance errors could be fatal.

[Assistant] Content: Class C verification of the DialyFlow Dialysis Fluid Controller requires unit testing with statement coverage of at least 90%, branch coverage of at least 80%, and MC/DC coverage of at least 80% for safety-critical modules. Integration testing per Clause 5.6 verifies all inter-unit interfaces including CAN bus, safety relay outputs. System-level verification per Clause 5.7 is performed by independent personnel not directly responsible for development.


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

[User]
Write a SDP section on risk control verification and traceability for FridgeGuard Temperature Logger, a Class A Cold Chain Temperature Logger. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Firmware logging refrigerator temperatures for vaccine and medication cold chain compliance. Records and displays data, no alerts that drive clinical decisions.

[Assistant] Content: Risk control verification for the FridgeGuard Temperature Logger 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 Cold Chain Temperature Logger.


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

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

"System testing for the NurseCall Hub verifies that all software requirements are met in the operational environment. Test failures trigger the software problem resolution process per Clause 9. No unit-level or integration-level tests are required for this Class A 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 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 AnticoagCalc INR Dose Adjuster, a Class B Anticoagulation Dosing Support Tool. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
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 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 Anticoagulation Dosing Support Tool 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 HydroLog (hydration tracking wellness app, Class A):

"The HydroLog integration testing approach uses bottom-up integration with stub drivers replaced incrementally as real components become available."

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


[System] You are a regulatory 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):

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

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


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

[User]
Write a SRS section on data processing and transformation requirements for NeoFeed Neonatal Feeding Pump, a Class C Neonatal Feeding Pump Firmware. Reference IEC 62304 Clause 5.2.2.
Syringe pump firmware for precise enteral feeding in NICU patients. Flow accuracy is critical for extremely low birth weight infants.

[Assistant] Content: Data processing requirements for the NeoFeed Neonatal Feeding Pump define the transformations applied to raw input from linear encoder to produce the output presented to the user. Each transformation has defined accuracy bounds and error handling behavior specific to the Neonatal Feeding Pump Firmware operational context.


[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: "audit trail and data export" (Category: functional)
Project: ConveyorGuard Safety Interlock System | Conveyor Safety Interlock Software | Class A
Monitoring safety interlocks and emergency stops on industrial conveyor systems. Safety PLC program monitoring conveyor belt guard positions, emergency stops, and light curtains. Functional safety application.

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 Conveyor Safety Interlock Software shall maintain a timestamped record of all measurements in non-volatile storage, supporting export via safety PLC I/O.
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 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-005: "audit trail and data export" (Category: functional)
Project: RadOnco Cloud Treatment Planner | Cloud Radiation Treatment Planning SaMD | Class C
Cloud-based Monte Carlo dose calculation and treatment plan optimization for radiation oncology. Cloud-based radiation oncology treatment planning system using GPU clusters for Monte Carlo dose calculation. Treatment plans directly drive linear accelerator delivery.

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 RadOnco Cloud Treatment Planner shall log measurement data with timestamps to non-volatile storage and provide a mechanism to retrieve logged data via DICOM RT import/export.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Cloud Radiation Treatment Planning SaMD.
Priority: Desirable
Acceptance Criterion: Logged data is retrievable after power cycle, with all timestamps accurate to within 1 second of the reference clock.
Source: User need


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

[User]
Write a SRS section on data format and interoperability requirements for OBDView Diagnostic Display, a Class A Vehicle Diagnostic Display App. Reference IEC 62304 Clause 5.2.2.
Mobile app connecting to vehicle OBD-II port to display engine parameters, fault codes, and emissions data.

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


[System] You are 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):

"Compliance with IEC 62304 Clause 7.5 is demonstrated through performance benchmarking."

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


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

[User]
Write a FMEA section on risk control measures and implementation for DermaAssist Skin Lesion Classifier, a Class B Skin Lesion Classification App. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Mobile app using a CNN to classify skin lesion images as benign/suspicious. Decision support requiring dermatologist confirmation.

[Assistant] Content: The DermaAssist Skin Lesion Classifier risk controls per Clause 7.2.1 address each failure mode with unacceptable residual risk. Software-implemented controls per Clause 7.2.2 include defensive coding measures, plausibility checks, and safe-state transitions. Each control is documented as a software requirement and verified for the Skin Lesion Classification App.


[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):

"Each software unit of the CaloriePal shall have corresponding unit test cases with full branch coverage."

[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 SRS section on purpose of the SRS document for RemotICU Continuous Monitoring Hub, a Class B Edge-to-Cloud ICU Monitoring Gateway. Reference IEC 62304 Clause 5.2.1.
Edge gateway collecting data from bedside monitors (SpO2, HR, BP, ventilator) and streaming to cloud for trending, alerting, and tele-ICU review.

[Assistant] Content: This Software Requirements Specification defines the functional, performance, and interface requirements for the RemotICU Continuous Monitoring Hub Edge-to-Cloud ICU Monitoring Gateway. Requirements are derived from system requirements, the risk management file, and stakeholder needs analysis per IEC 62304 Clause 5.2.1. Each requirement is uniquely identified, prioritized, and traceable to its source.


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

[User]
Expand requirement SRS-FUNC-002: "device configuration management" (Category: functional)
Project: AnticoagCalc INR Dose Adjuster | Anticoagulation Dosing Support Tool | Class B
Suggesting warfarin dose adjustments based on INR values for physician review. Web tool suggesting warfarin dose adjustments based on INR readings and patient history. Clinical decision support requiring physician review.

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

[Assistant]
Description: Operating parameters of the Anticoagulation Dosing Support Tool shall be user-configurable within validated ranges and stored in non-volatile memory.
Rationale: Configurable parameters allow the Anticoagulation Dosing Support Tool to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: Configuration round-trip test: set, power-cycle, read-back for all parameters with 100% accuracy.
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 TRACE section on traceability scope including risk controls for VibeCheck Vibration Analyzer, a Class A Vibration Analysis Instrument Firmware. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Portable vibration analysis firmware for predictive maintenance of industrial rotating machinery. FFT analysis of accelerometer data.

[Assistant] Content: Traceability for the VibeCheck Vibration Analyzer Vibration Analysis Instrument Firmware covers all software requirements per Clause 5.7.1 and all software-implemented risk controls per Clause 7.3.2. The combined matrix provides a single view of verification completeness for functional and safety aspects.


[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 OBDView Diagnostic Display, a Class A Vehicle Diagnostic Display App. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Mobile app connecting to vehicle OBD-II port to display engine parameters, fault codes, and emissions data.

[Assistant] Content: Failure mode documentation for the OBDView Diagnostic Display per Clause 7.1.4 captures the complete chain from cause to effect for each identified failure. The FMEA worksheet records the affected function, failure mode, potential causes, effects on the Vehicle Diagnostic Display App user, and current detection mechanisms.


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

[User]
Expand requirement SRS-DATA-003: "measurement record integrity" (Category: data)
Project: SunGuard UV Index Display | UV Exposure Display Firmware | Class A
Passive display of UV index for personal awareness. Wearable UV index monitor with an OLED display showing current UV exposure level. Informational only, no sunburn prevention claims.

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 SunGuard UV Index Display shall validate the integrity of stored data using checksums, detecting and reporting any corruption of measurement records.
Rationale: Data integrity mechanisms ensure measurement records retrieved from the UV Exposure Display Firmware are trustworthy for clinical review.
Priority: Mandatory
Acceptance Criterion: Integrity check correctly identifies all corrupted records with zero false positives on uncorrupted data.
Source: System requirement


[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 lifecycle processes for the LabView Portal comply with ISO 13485-1."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 13485-1" which is incorrect. ISO 13485 is a single-part standard. The correct citation is ISO 13485:2016. All references must be corrected.


[System] You are 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):

"ISO 14971-1 Section 5.5 requires all software units to be verified."

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


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

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

"The lifecycle processes for the SleepWell comply with ISO 13485-1."

[Assistant]
Verdict: FAIL
Note: The documentation references "ISO 13485-1" which is incorrect. ISO 13485 is a single-part standard. The correct citation is ISO 13485:2016. All references must be corrected.


[System] You are 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 BillingBridge Claims Processor, a Class A Claims Processing Service. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Backend service processing insurance claims from the hospital billing system. Financial processing only, no clinical data.

[Assistant] Content: Documentation of BillingBridge Claims Processor failure modes follows Clause 7.1.4. Each entry in the FMEA register includes: the software item, the failure mode, the potential cause(s), the effect on the Claims Processing Service during Automated processing and submission of insurance claims, severity and probability ratings, and references to applicable 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 SDP section on scope boundaries of the software system for BalanceBoard Vestibular Trainer, a Class B Balance Training Platform Firmware. Reference IEC 62304 Clauses 5.1.1, 5.1.2.
Force plate firmware measuring center-of-pressure excursions during balance exercises. Provides real-time visual biofeedback.

[Assistant] Content: This plan applies to all software executing within the BalanceBoard Vestibular Trainer Balance Training Platform Firmware and its supporting build and verification infrastructure. External systems that exchange data with the Balance Training Platform Firmware via USB are covered only at the interface boundary; their internal implementation is outside the scope of this SDP.


[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):

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

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


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

[User]
Write a SDP section on change control process for RetinaScan Diabetic Retinopathy Screener, a Class B Retinal Screening Software. Reference IEC 62304 Clauses 8.2, 8.2.1.
Desktop software analyzing retinal fundus images to detect signs of diabetic retinopathy for ophthalmologist review.

[Assistant] Content: Changes to the RetinaScan Diabetic Retinopathy Screener software baseline require a documented change request approved before implementation. The change control process per Clause 8.2 includes impact assessment on safety, regression risk evaluation, and verification of the change before integration into the controlled baseline.


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

[User]
Write a SRS section on functional requirements overview for TeleRehab Remote Patient Monitor, a Class B Remote Rehabilitation Platform. Reference IEC 62304 Clause 5.2.2.
Platform enabling remote physiotherapy with video consultations and wearable sensor data streaming. Generates exercise adherence reports.

[Assistant] Content: Functional requirements for the TeleRehab Remote Patient Monitor specify the data processing, user interaction, and output generation capabilities of the Remote Rehabilitation Platform. Each requirement describes a discrete function the software shall perform during Remote physiotherapy monitoring with exercise tracking and therapist-patient video sessions, with acceptance criteria sufficient to derive verification test cases.


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

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

[Assistant]
Description: An independent hardware watchdog shall monitor the PainRelief PCA Pump Controller main processing loop, triggering a safe-state reset if the software fails to service the watchdog within the specified timeout.
Rationale: Hardware-independent monitoring ensures that a frozen main processor cannot leave the PCA Pump Controller Firmware in an unsafe operating state.
Priority: Mandatory
Acceptance Criterion: Watchdog triggers safe-state reset within the specified timeout when the main loop is intentionally blocked, verified across 20 iterations.
Source: Risk control


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

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

"Architectural design follows IEC 62304:2020 Clause 5.3 for Class A devices."

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


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

[User]
Expand requirement SRS-PERF-001: "real-time performance requirement" (Category: performance)
Project: HydroRemind Hydration Tracker | Hydration Tracking Firmware | Class A
Passive display of daily water consumption for wellness. Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

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

[Assistant]
Description: End-to-end latency from Hall-effect flow sensor data acquisition to output presentation shall not exceed the specified limit under normal operating conditions.
Rationale: Bounded processing latency ensures the Hydration Tracking Firmware provides readings reflecting the current state without clinically significant delay.
Priority: Mandatory
Acceptance Criterion: End-to-end latency is within the specified limit for 99.9% of samples over a 24-hour test period.
Source: System requirement


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

[User]
Expand requirement SRS-INTF-002: "external system data exchange" (Category: interface)
Project: HeartView Resting HR Display | Heart Rate Display Firmware | Class A
Passive display of resting heart rate for wellness monitoring. Wearable firmware that shows resting heart rate on a small OLED screen. Read-only display with no arrhythmia detection or clinical alerts.

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 Heart Rate Display Firmware shall support bidirectional data exchange with external systems over I2C.
Rationale: Interoperability enables integration of Heart Rate Display Firmware data into the clinical workflow and patient record.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


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

[User]
Write a SDP section on SOUP identification and management for VitalPulse SpO2 Monitor, a Class B Pulse Oximeter Firmware. Reference IEC 62304 Clause 8.1.2.
Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

[Assistant] Content: SOUP components in the VitalPulse SpO2 Monitor are catalogued per Clause 8.1.2 with title, version, supplier, and license terms. The risk management process evaluates each SOUP item's known anomaly list per Clause 7.1.3 to determine whether any published defect could contribute to a hazardous situation in the Pulse Oximeter 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 lightweight review process for Class A for AutoclaveLog Cycle Recorder, a Class A Sterilization Cycle Data Logger. Reference IEC 62304 Clause 5.1.1.
PC software recording autoclave cycle data (time, temperature, pressure) and generating compliance reports.

[Assistant] Content: The AutoclaveLog Cycle Recorder review process is proportionate to the Class A risk level. The project lead reviews each deliverable for technical accuracy, and the quality representative verifies compliance with SOPs. Reviews are documented but do not require independent technical review of the Sterilization Cycle Data Logger verification activities.


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

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

"Standards compliance for the ChemoCalc chemotherapy dose calculator is established through IEC 62304:2006+AMD1:2015 (Clauses 5, 7, 8, 9), ISO 14971:2019 (all clauses), and ISO 13485:2016 (Clause 7.3 design controls). All citations reference the current editions."

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


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

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

"The MedInventory 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 change control process for CardioRhythm ECG Analyzer, a Class B Single-Lead ECG Device Firmware. Reference IEC 62304 Clauses 8.2, 8.2.1.
Portable ECG device firmware acquiring single-lead ECG and classifying basic rhythm types. Incorrect classification could delay diagnosis.

[Assistant] Content: Changes to the CardioRhythm ECG Analyzer software baseline require a documented change request approved before implementation. The change control process per Clause 8.2 includes impact assessment on safety, regression risk evaluation, and verification of the change before integration into the controlled baseline.


[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 HemaCount Digital Cell Counter, a Class B IVD Digital Cell Counter Software. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Desktop software performing automated differential white blood cell counting on digitized blood smear images using computer vision.

[Assistant] Content: Failure mode documentation for the HemaCount Digital Cell Counter per Clause 7.1.4 captures the complete chain from cause to effect for each identified failure. The FMEA worksheet records the affected function, failure mode, potential causes, effects on the IVD Digital Cell Counter Software user, and current detection mechanisms.


[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 InsuPrecise Insulin Pump Controller, a Class C Insulin Pump Controller Firmware. Reference IEC 62304 Clause 5.7.4.
Embedded firmware controlling insulin delivery in a patch-type insulin pump. Incorrect dosing could cause severe hypoglycemia or diabetic ketoacidosis.

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


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

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

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

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


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

[User]
Expand requirement SRS-SEC-002: "cryptographic data security" (Category: security)
Project: WeightAlert Neonatal Scale | Neonatal Scale Firmware | Class B
Precision weight measurement for neonatal patients with change-rate alerting. Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

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 WeightAlert Neonatal Scale shall encrypt patient-identifiable data at rest, ensuring that raw storage access cannot reveal protected health information.
Rationale: Data-at-rest encryption is required to meet privacy regulations and protect patient confidentiality.
Priority: Mandatory
Acceptance Criterion: Cryptographic implementation validated against NIST standards with no known vulnerabilities in the selected algorithm.
Source: Regulatory


[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):

"Software safety classification is performed per IEC 62304-6 Clause 4.3."

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


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

[User]
Write a SDP section on development tools and tool qualification for Class A for NutriView Food Diary, a Class A Nutritional Tracking Display App. Reference IEC 62304 Clause 5.1.4.
Mobile app for manual food logging with nutritional summary display. No dietary recommendations or medical nutrition therapy.

[Assistant] Content: The NutriView Food Diary is developed in TypeScript/React Native targeting the iOS/Android platform. Source code is maintained under version control with branching and tagging conventions defined in SOP-012. For the Class A Nutritional Tracking Display App, formal tool qualification is not required per IEC 62304; however, the development toolchain is verified to function correctly through routine build-and-test cycles.


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

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

"REQ-SRS-067: The EchoAssist shall enforce role-based access control with at least two privilege levels (operator and administrator). Acceptance criterion: verify that operator accounts cannot access administrator functions. Priority: Mandatory. Source: Regulatory."

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