[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: "real-time performance requirement" (Category: performance)
Project: AquaGuard Water Quality Monitor | Water Quality Monitoring Firmware | Class A
In-situ measurement of water quality parameters for environmental monitoring. Firmware for a multi-parameter water quality probe measuring pH, dissolved oxygen, conductivity, and turbidity in rivers and lakes.

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

[Assistant]
Description: Processing latency of the Water Quality Monitoring Firmware shall be bounded to ensure timely output that reflects current input conditions.
Rationale: Real-time performance is critical for the Water Quality Monitoring Firmware to support timely clinical decisions based on current data.
Priority: Mandatory
Acceptance Criterion: Worst-case latency measured under maximum load conditions does not exceed the specified absolute maximum.
Source: System requirement


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

[User]
Write a SRS section on data processing and transformation requirements for NutriView Food Diary, a Class A Nutritional Tracking Display App. Reference IEC 62304 Clause 5.2.2.
Mobile app for manual food logging with nutritional summary display. No dietary recommendations or medical nutrition therapy.

[Assistant] Content: Data processing requirements for the NutriView Food Diary define the transformations applied to raw input from data sources to produce the output presented to the user. Each transformation has defined accuracy bounds and error handling behavior specific to the Nutritional Tracking Display App 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 primary international standards applicable to development for DermaLens Teledermatology Platform, a Class B Cloud Teledermatology SaMD. Reference IEC 62304 Clause 5.1.2.
Cloud platform enabling dermatologists to review patient-submitted skin images with AI-assisted triage scoring. Images uploaded from mobile app to cloud pipeline.

[Assistant] Content: Applicable standards for the DermaLens Teledermatology Platform include IEC 62304:2006+AMD1:2015 (software lifecycle), ISO 14971:2019 (risk management), ISO 13485:2016 (quality management), and IEC 62366-1:2015+AMD1:2020 (usability engineering). These standards collectively define the processes, documentation, and verification expectations for the Cloud Teledermatology SaMD.


[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: "data logging and retrieval" (Category: functional)
Project: FleetTrack GPS Tracking Module | Fleet GPS Tracking Firmware | Class A
Real-time GPS tracking and geofence monitoring of fleet vehicles. Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

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 Fleet GPS Tracking Firmware shall maintain a timestamped record of all measurements in non-volatile storage, supporting export via LTE-M cellular.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Fleet GPS Tracking Firmware.
Priority: Desirable
Acceptance Criterion: Data retrieval produces complete, uncorrupted records for the full specified retention period.
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 baseline security requirements for SterilLog Sterilization Record System, a Class A Sterilization Record Logger. Reference IEC 62304 Clause 5.2.2.
Software logging sterilization cycle parameters from autoclaves. Records temperature, pressure, and time for compliance documentation.

[Assistant] Content: The SterilLog Sterilization Record System Sterilization Record Logger implements security controls per IEC 81001-5-1:2021: user authentication, role-based access control, encrypted storage, encrypted communications, and event logging. Security requirements are verified through system testing and documented in the security test report.


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

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

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

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


[System] You are 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):

"Code reviews by personnel independent of the development team are mandatory for all changes."

[Assistant]
Verdict: FAIL
Note: Content mandates independent review for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Independent review is required only for Class C (Clause 5.5.4, 5.7.4).


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

[User]
Expand requirement SRS-DATA-001: "record keeping duration" (Category: data)
Project: AllergyCard Patient Allergy Viewer | Patient Allergy Display | Class A
Read-only display of patient allergy information at point of care. Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

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

[Assistant]
Description: Data retention in the AllergyCard Patient Allergy Viewer shall meet the specified minimum duration, with oldest records overwritten only after the retention period expires.
Rationale: Regulatory compliance requires that measurement records be available for the specified retention period.
Priority: Mandatory
Acceptance Criterion: Oldest data record remains retrievable after continuous operation for the specified retention period.
Source: Regulatory


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

[User]
Write a SDP section on lightweight review process for Class A for PathSlide Digital Pathology Viewer, a Class A Digital Pathology Viewer. Reference IEC 62304 Clause 5.1.1.
Web viewer for whole-slide digital pathology images. Pan, zoom, and annotation display. No AI-assisted diagnosis.

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


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

[User]
Write a SAD section on SOUP risk evaluation and anomaly management for DoseVerify In-Vivo Dosimetry System, a Class C In-Vivo Dosimetry Verification Software. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Software calculating real-time delivered dose from in-vivo dosimeter readings during radiation therapy. Dose verification for patient safety.

[Assistant] Content: The DoseVerify In-Vivo Dosimetry System SOUP risk assessment per Clause 7.1.3 documents all known SOUP defects relevant to the In-Vivo Dosimetry Verification Software 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 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):

"ISO 62304 Section 9.1 requires all software units to be verified."

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


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

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

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

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


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

[User]
Write a SDP section on tool qualification for Class B and C for GlucoEdge Continuous Glucose Platform, a Class B Hybrid CGM Edge-Cloud Platform. Reference IEC 62304 Clause 5.1.4.
Hybrid system: embedded BLE firmware on a wearable CGM patch streams readings to a phone app, which uploads to cloud for trend analysis and physician dashboard.

[Assistant] Content: Tool qualification for the GlucoEdge Continuous Glucose Platform is performed for all tools whose output directly supports verification conclusions, per Clause 5.1.4. Qualified tools include the C (firmware) + Swift/Kotlin (mobile) + Python (cloud) build toolchain, code coverage analyzers, and the system test harness. Each tool's qualification record is maintained as a controlled document.


[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 independent review process for Class C for PaceSet Pacemaker Programmer, a Class C Cardiac Pacemaker Programmer Software. Reference IEC 62304 Clause 5.1.1.
Desktop software for interrogating and programming cardiac pacemakers via telemetry wand. Incorrect programming could cause pacing failure.

[Assistant] Content: Class C review for the PaceSet Pacemaker Programmer involves three parties: the development team (self-review), the quality assurance function (process compliance), and an independent technical reviewer (technical adequacy). Each review is documented with findings, dispositions, and approvals. No deliverable for the Cardiac Pacemaker Programmer Software is released without sign-off from all three parties.


[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 AssetTrack Equipment Inventory, a Class A Equipment Inventory System. Reference IEC 62304 Clause 5.2.2.
Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management only.

[Assistant] Content: The AssetTrack Equipment Inventory Equipment Inventory System external communication requirements cover data exchange with remote systems. Each requirement specifies the message format, transport protocol, retry policy, and failure mode behavior, ensuring the Equipment Inventory System degrades safely if communication is disrupted.


[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: "record keeping duration" (Category: data)
Project: HumidityMap Room Condition Logger | Environmental Condition Logger | Class A
Monitoring and logging temperature/humidity in hospital storage areas. Network of IoT sensors logging temperature and humidity across hospital storage areas. Dashboard display for facility management.

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

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


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

[User]
Expand requirement SRS-INTF-001: "data export and interoperability" (Category: interface)
Project: PaceSet Pacemaker Programmer | Cardiac Pacemaker Programmer Software | Class C
Programming and interrogating implanted cardiac pacemakers including rate settings, sensitivity, and output parameters. Desktop software for interrogating and programming cardiac pacemakers via telemetry wand. Incorrect programming could cause pacing failure.

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 PaceSet Pacemaker Programmer shall exchange data with external systems via proprietary RF using the specified message format with error handling.
Rationale: Interoperability enables integration of Cardiac Pacemaker Programmer Software data into the clinical workflow and patient record.
Priority: Desirable
Acceptance Criterion: Format validation passes for all message types with correct field encoding verified.
Source: User need


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

[User]
Write a SAD section on interface design between software items for InfuRate IV Flow Calculator, a Class B Infusion Rate Calculator. Reference IEC 62304 Clause 5.3.2.
Desktop calculator for IV infusion rates based on drug concentration, patient weight, and ordered dose. Clinical decision support tool.

[Assistant] Content: Software item interfaces in the InfuRate IV Flow Calculator architecture are specified per Clause 5.3.2 with sufficient detail to support independent implementation and verification. Each interface definition includes data format, timing constraints, and error handling contracts applicable to the Infusion Rate Calculator.


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

[User]
Write a SDP section on hazard identification for the specific device for InsuPrecise Insulin Pump Controller, a Class C Insulin Pump Controller Firmware. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Embedded firmware controlling insulin delivery in a patch-type insulin pump. Incorrect dosing could cause severe hypoglycemia or diabetic ketoacidosis.

[Assistant] Content: Hazard identification for the InsuPrecise Insulin Pump Controller per Clause 7.1.2 considers all software functions that could contribute to patient harm. Identified causes include incorrect micro-flow sensor processing, loss of communication on BLE 5.0 to companion app, and failure to detect out-of-range conditions during Automated insulin delivery control with programmable basal rates and bolus calculations.


[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-001: "primary sensor interface protocol" (Category: interface)
Project: SurgLog Procedure Documentation App | Surgical Documentation App | Class A
Documentation and review of surgical procedure notes. Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

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

[Assistant]
Description: The SurgLog Procedure Documentation App shall communicate with the tablet microphone via REST API, implementing error detection and recovery for communication failures.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Surgical Documentation App output.
Priority: Mandatory
Acceptance Criterion: Error injection tests confirm 100% detection rate for corrupted frames and recovery within specified timeout.
Source: System requirement


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

[User]
Write a THREAT section on STRIDE threat categories applied to the device for AutoPancreas Closed-Loop Glucose Controller, a Class C Artificial Pancreas Controller Firmware. Reference IEC 62304 Clause 5.2.2.
Artificial pancreas firmware integrating CGM readings with insulin pump delivery using a PID control algorithm. Life-sustaining closed-loop system.

[Assistant] Content: Threats to the AutoPancreas Closed-Loop Glucose Controller are categorized using the STRIDE framework: Spoofing of BLE to CGM identity, Tampering with sensor data or configuration, Repudiation of clinical actions, Information Disclosure of patient data, Denial of Service disrupting Automated closed-loop insulin delivery based on continuous glucose monitoring with predictive algorithms, and Elevation of Privilege through unauthorized parameter changes.


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

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

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

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


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

[User]
Write a SDP section on verification strategy for Class B -- integration and system testing for RenalDose Renal Adjustment Calculator, a Class B Renal Dose Adjustment Calculator. Reference IEC 62304 Clauses 5.6, 5.6.3, 5.7.
Calculator adjusting medication doses for patients with impaired renal function based on eGFR.

[Assistant] Content: The Class B verification strategy for the RenalDose Renal Adjustment Calculator includes integration testing per Clause 5.6 and system testing per Clause 5.7. Integration tests validate the interaction between input processing, manual input communication, and output subsystems. System tests confirm end-to-end behavior of the Renal Dose Adjustment Calculator against the SRS.


[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 NurseCall Hub (patient call system dashboard, Class A):

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

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


[System] You are 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 DermaScan AI (skin lesion classifier, Class B):

"The DermaScan AI development environment is configured following best practices. Tools are selected as appropriate for the project requirements."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as appropriate", "best practices" provide no project-specific information about the DermaScan AI skin lesion classifier. 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 requirements conventions and identification scheme for HomeVent BiPAP Controller, a Class C BiPAP Device Firmware. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Home bilevel positive airway pressure device firmware. Manages inspiratory/expiratory pressure, leak compensation, and patient triggering.

[Assistant] Content: Each requirement for the HomeVent BiPAP Controller is assigned a unique identifier and tagged with its type (functional, performance, interface, or safety) per Clause 5.2.2. Requirements are written in "shall" statements that are individually testable. The requirement set is baselined and controlled under the change management process.


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

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

"Problem resolution for the ArthroNav follows Clause 9. Problem reports capture severity, affected version, and steps to reproduce (Clause 9.1). Investigation per Clause 9.2 determines root cause. Trends are analyzed per Clause 9.6 at each milestone review."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the ArthroNav (surgical navigation system, Class C). Standards references are accurate.


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

[User]
Write a SRS section on system boundaries and external dependencies for CalibrationTracker Equipment Logger, a Class A Calibration Record System. Reference IEC 62304 Clause 5.2.2.
Web application tracking calibration dates and results for medical test equipment. Administrative record keeping.

[Assistant] Content: System boundaries for the CalibrationTracker Equipment Logger are defined at the software interface level. The Calibration Record System receives input from external sensors and produces output via REST API. Components beyond these interfaces are outside the scope of this SRS and are addressed in system-level documentation.


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

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

"Formal code inspections by independent reviewers are required for all LabView Portal source code. Each module shall have unit tests with full branch coverage."

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


[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 TransVent Transport Ventilator, a Class C Transport Ventilator Firmware. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Portable transport ventilator firmware for ambulance and helicopter use. Must maintain ventilation under vibration and altitude changes.

[Assistant] Content: Risk control coverage analysis for the TransVent Transport Ventilator per Clause 7.3.2 confirms that every software-implemented risk control has a linked verification result demonstrating its effectiveness. Any risk control without verification evidence is treated as a critical gap blocking release of the Transport Ventilator Firmware.


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

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

"Software problem resolution follows IEC 14971 Clause 9."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 14971" which is incorrect. Wrong prefix. The correct standard is ISO 14971, not IEC 14971. 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 CaloriePal (nutrition tracking app, Class A):

"Code reviews for the CaloriePal shall be performed by at least two reviewers independent of the development team, following a formal checklist."

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


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

[User]
Expand requirement SRS-FUNC-004: "display update rate for Physical Therapy Tracking System" (Category: functional)
Project: PhysioTrack Rehabilitation Monitor | Physical Therapy Tracking System | Class B
Tracking exercise performance and range of motion during physical therapy for therapist review. Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

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 PhysioTrack Rehabilitation Monitor display shall present current readings on BLE 5.0 within the specified maximum update latency.
Rationale: Display freshness is critical for the Physical Therapy Tracking System to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: End-to-end latency from data acquisition to display update does not exceed the specified limit for 99.9% of samples.
Source: User need


[System] You are 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 TransVent Transport Ventilator, a Class C Transport Ventilator Firmware. Reference IEC 62304 Clause 5.1.1.
Portable transport ventilator firmware for ambulance and helicopter use. Must maintain ventilation under vibration and altitude changes.

[Assistant] Content: The TransVent Transport Ventilator follows a strict V-model lifecycle with no phase abbreviations permitted. Requirements trace to architecture, architecture traces to detailed design, and each trace is verified by independent reviewers. Unit testing with coverage targets, integration testing, and system testing form the ascending verification arm, each gated by formal review of the Transport Ventilator Firmware test results.


[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):

"System testing for the HydroLog is conducted per Clause 5.7.1 through 5.7.5. Test procedures verify end-to-end functionality of the hydration tracking wellness app against approved requirements. Detailed design verification (Clause 5.4), unit verification (Clause 5.5), and integration testing (Clause 5.6) are excluded as not applicable to Class A."

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


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

[User]
Write a SDP section on SOUP identification and management for WoundTrack Healing Analyzer, a Class B Wound Assessment App. Reference IEC 62304 Clause 8.1.2.
Mobile app photographing wounds and measuring area/perimeter over time to track healing progress for clinician review.

[Assistant] Content: All software of unknown provenance used in the WoundTrack Healing Analyzer is identified and documented per Clause 8.1.2. For each SOUP component, the name, version, manufacturer, and intended use within the Wound Assessment App are recorded. Known anomaly lists for each SOUP item are evaluated during risk analysis per Clause 7.1.3.


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

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

"In accordance with IEC 62304-5, verification activities include system testing."

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


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

[User]
Expand requirement SRS-DATA-003: "measurement data lifecycle" (Category: data)
Project: MindCalm Meditation Timer | Meditation Wellness App | Class A
Guided meditation timing with optional passive biometric display. Mobile app providing guided meditation timers with optional heart rate display during sessions. Heart rate shown for interest only, not diagnostic.

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

[Assistant]
Description: The MindCalm Meditation Timer shall retain measurement data in non-volatile storage for the specified minimum retention period, after which data may be overwritten.
Rationale: Regulatory compliance requires that measurement records be available for the specified retention period.
Priority: Mandatory
Acceptance Criterion: Retention period validation: records created at time T are still accessible at T + retention period.
Source: Regulatory


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

[User]
Write a SDP section on scope boundaries of the software system for ChemoFlow Infusion Controller, a Class C Chemotherapy Infusion Pump Firmware. Reference IEC 62304 Clauses 5.1.1, 5.1.2.
Firmware for a chemotherapy infusion pump controlling precise drug delivery rates. Dosing errors could be life-threatening.

[Assistant] Content: The ChemoFlow Infusion Controller software boundary includes the application firmware, configuration data, and all SOUP components deployed on ARM Cortex-R5 (lockstep). Hardware components, operating system kernels supplied by the platform vendor, and remote services accessed via RS-232 drug library are excluded from the software lifecycle activities defined here, though their influence on software behavior is addressed in the risk analysis.


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

[User]
Expand requirement SRS-PERF-002: "memory usage budget" (Category: performance)
Project: RoomBoard Digital Signage | Patient Room Digital Signage | Class A
Displaying non-clinical patient information on bedside screens. Hospital room digital signage displaying patient name, care team, and daily schedule. Display-only, no clinical data entry.

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 Patient Room Digital Signage shall not exceed the allocated budget, with sufficient margin for stack overflow protection.
Rationale: Memory constraints are fixed by the Raspberry Pi / Chrome kiosk 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 an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on safety classification process and documentation for NutriView Food Diary, a Class A Nutritional Tracking Display App. Reference IEC 62304 Clause 4.3.
Mobile app for manual food logging with nutritional summary display. No dietary recommendations or medical nutrition therapy.

[Assistant] Content: The NutriView Food Diary safety classification is a prerequisite for determining the scope of IEC 62304 lifecycle activities. The classification was performed per Clause 4.3 using hazard analysis inputs from the ISO 14971 risk management process. Changes to the Nutritional Tracking Display App intended use or risk profile trigger reclassification.


[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 AutoPancreas Closed-Loop Glucose Controller, a Class C Artificial Pancreas Controller Firmware. Reference IEC 62304 Clause 5.2.2.
Artificial pancreas firmware integrating CGM readings with insulin pump delivery using a PID control algorithm. Life-sustaining closed-loop system.

[Assistant] Content: Functional requirements for the AutoPancreas Closed-Loop Glucose Controller are derived from the system requirements for Automated closed-loop insulin delivery based on continuous glucose monitoring with predictive algorithms and from risk control measures identified in the ISO 14971 analysis. Each requirement specifies a single function of the Artificial Pancreas Controller Firmware with measurable acceptance criteria.


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

[User]
Write a FMEA section on failure mode identification approach for NutriCalc TPN Formulation Tool, a Class B TPN Formulation Calculator. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

[Assistant] Content: Failure modes for each NutriCalc TPN Formulation Tool software function are identified by systematic analysis of data flow paths, processing algorithms, and interface transactions. For each function, the analysis considers: incorrect output, missing output, output at wrong time, and unexpected output. Causes include coding defects, resource exhaustion, race conditions, and corrupted input from external sources.


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

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

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

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


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

[User]
Write a SRS section on functional requirements overview for CleanRoom Particle Counter Logger, a Class A Cleanroom Environmental Logger. Reference IEC 62304 Clause 5.2.2.
Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

[Assistant] Content: Functional requirements for the CleanRoom Particle Counter Logger specify the data processing, user interaction, and output generation capabilities of the Cleanroom Environmental Logger. Each requirement describes a discrete function the software shall perform during Logging and displaying airborne particle counts for cleanroom compliance, with acceptance criteria sufficient to derive verification test cases.


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

[User]
Write a SRS section on requirements conventions and identification scheme for WeatherNode Microclimate Station, a Class A Weather Station Firmware. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Solar-powered weather station firmware measuring temperature, humidity, wind, rainfall, and barometric pressure.

[Assistant] Content: Each requirement for the WeatherNode Microclimate Station is assigned a unique identifier and tagged with its type (functional, performance, interface, or safety) per Clause 5.2.2. Requirements are written in "shall" statements that are individually testable. The requirement set is baselined and controlled under the change management process.


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

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

"Verification activities follow IEC 62304 Clause 5.7.6 for security testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.7.6 which does not exist. Clause 5.7 has 5.7.1 through 5.7.5 only. The reference must be corrected to a valid clause number.


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

[User]
Write a SDP section on minimal deliverables list for Class A for HydroRemind Hydration Tracker, a Class A Hydration Tracking Firmware. Reference IEC 62304 Clause 5.1.8.
Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

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


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

[User] Can I cite IEC 81001-5-1:2021 in my documentation?

[Assistant] Yes. IEC 81001-5-1:2021 covers security in the health software lifecycle. It is harmonized under EU MDR.


[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 ConveyorGuard Safety Interlock System, a Class A Conveyor Safety Interlock Software. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Safety PLC program monitoring conveyor belt guard positions, emergency stops, and light curtains. Functional safety application.

[Assistant] Content: Failure mode documentation for the ConveyorGuard Safety Interlock System 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 Conveyor Safety Interlock Software user, and current detection mechanisms.


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

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

"Integration testing validates the interaction between all MedInventory software components."

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


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

[User]
Write a SDP section on safety classification process and documentation for RadOnco Cloud Treatment Planner, a Class C Cloud Radiation Treatment Planning SaMD. Reference IEC 62304 Clause 4.3.
Cloud-based radiation oncology treatment planning system using GPU clusters for Monte Carlo dose calculation. Treatment plans directly drive linear accelerator delivery.

[Assistant] Content: The RadOnco Cloud Treatment Planner safety classification is a prerequisite for determining the scope of IEC 62304 lifecycle activities. The classification was performed per Clause 4.3 using hazard analysis inputs from the ISO 14971 risk management process. Changes to the Cloud Radiation Treatment Planning SaMD intended use or risk profile trigger reclassification.


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

[User]
Write a TRACE section on gap identification and coverage analysis for OBDView Diagnostic Display, a Class A Vehicle Diagnostic Display App. Reference IEC 62304 Clause 5.7.4.
Mobile app connecting to vehicle OBD-II port to display engine parameters, fault codes, and emissions data.

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


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

[User]
Write a SDP section on development methodology for Class A for MedRef Clinical Reference App, a Class A Clinical Drug Reference App. Reference IEC 62304 Clause 5.1.1.
Standalone mobile app providing searchable drug reference database with interaction checker. Display-only — no prescription or dosing decisions.

[Assistant] Content: The MedRef Clinical Reference App follows an agile-inspired iterative lifecycle with lightweight phase gates suited to Class A software. Milestones are Requirements Baseline, Implementation Freeze, and System Test Complete. No architecture review or detailed design review gate is required, as these artifacts are not mandated for Class A.


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

[User]
Write a TRACE section on traceability scope including risk controls for AuditTrail QMS Event Logger, a Class A QMS Audit Trail Service. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Microservice capturing and storing quality management system audit events. Logging and reporting only.

[Assistant] Content: The AuditTrail QMS Event Logger traceability matrix extends beyond functional requirements to include risk control traceability per Clause 7.3.2. Each risk control measure implemented in the QMS Audit Trail Service software is traced from the ISO 14971 hazard through the software requirement to the verification test confirming its effectiveness.


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

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

"The development plan references IEC 62304 Clause Annex B.3 and Clause 9.9 for the OxyPure Controller."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses Annex B.3 and 9.9, neither of which exists. IEC 62304 annexes are not cited as requirements. Clause 9 has 9.1 through 9.8 only. All clause references must be corrected.


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

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

"Problem resolution is established for the DialysisGuard. Problems are reported. Problems are investigated. Problems are resolved. Problems are tracked. Problem resolution follows IEC 62304 Clause 9."

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


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

[User] What edition of IEC 62304 is current?

[Assistant] The current edition is IEC 62304:2006+AMD1:2015. The base standard was published in 2006, with Amendment 1 published in 2015. There is no 2020 or 2022 edition. Citations like 'IEC 62304:2020' or 'IEC 62304:2015' are incorrect.


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

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

"System testing for the SleepWell is conducted per Clause 5.7.1 through 5.7.5. Test procedures verify end-to-end functionality of the sleep quality display app against approved requirements. Detailed design verification (Clause 5.4), unit verification (Clause 5.5), and integration testing (Clause 5.6) are excluded as not applicable to Class A."

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


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

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

"Software problem resolution follows IEC 62304-1 Clause 9."

[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 CaloriePal (nutrition tracking app, Class A):

"IEC 14971 Section 5.3 requires all software units to be verified."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 14971" which is incorrect. Wrong prefix. The correct standard is ISO 14971, not IEC 14971. All references must be corrected.


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

[User]
Write a SAD section on error propagation and data integrity in the pipeline for WeightAlert Neonatal Scale, a Class B Neonatal Scale Firmware. Reference IEC 62304 Clause 5.3.2.
Neonatal scale firmware with high-precision weight measurement. Sudden weight changes may indicate fluid imbalance in NICU patients.

[Assistant] Content: Data integrity in the WeightAlert Neonatal Scale pipeline is maintained through validation at every software item boundary. The architecture specifies error codes, timeout behavior, and recovery actions for each interface. The Neonatal Scale Firmware logs all data integrity failures for post-deployment analysis.


[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: "data-at-rest encryption" (Category: security)
Project: AnesBot Automated Anesthesia Controller | Automated Anesthesia Delivery Software | Class C
Target-controlled propofol infusion guided by processed EEG depth-of-anesthesia monitoring. Software controlling target-controlled infusion of propofol based on BIS monitoring. Overdose could cause respiratory arrest.

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

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


[System] You are a 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):

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

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


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

[User]
Write a SDP section on risk control requirements traceability for RenalDose Renal Adjustment Calculator, a Class B Renal Dose Adjustment Calculator. Reference IEC 62304 Clause 5.2.3.
Calculator adjusting medication doses for patients with impaired renal function based on eGFR.

[Assistant] Content: Risk control measures identified in the ISO 14971 risk management process are traced to specific software requirements per Clause 5.2.3. For the RenalDose Renal Adjustment Calculator, this includes controls addressing input data failure modes, communication integrity on manual input, and data validation.


[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 PostureGuard Desk Monitor, a Class A Posture Wellness Display Software. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
USB webcam software that estimates sitting posture and displays a wellness score. No ergonomic prescriptions or clinical assessments.

[Assistant] Content: Risk control coverage analysis for the PostureGuard Desk Monitor per Clause 7.3.2 confirms that every software-implemented risk control has a linked verification result demonstrating its effectiveness. Any risk control without verification evidence is treated as a critical gap blocking release of the Posture Wellness Display Software.


[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: "data acquisition from pressure transducer" (Category: functional)
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: The PressoTrack Blood Pressure Trending shall continuously sample pressure transducer data, buffer readings in memory, and pass validated samples to the processing module without data loss.
Rationale: Continuous data acquisition from the primary sensor is the fundamental input for Automated periodic blood pressure measurement and trending over 24 hours.
Priority: Mandatory
Acceptance Criterion: System test confirms zero missed samples over a 24-hour continuous operation period at the maximum configured sampling rate.
Source: System requirement


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

[User]
Write a SDP section on development methodology for Class A for AuditTrail QMS Event Logger, a Class A QMS Audit Trail Service. Reference IEC 62304 Clause 5.1.1.
Microservice capturing and storing quality management system audit events. Logging and reporting only.

[Assistant] Content: The AuditTrail QMS Event Logger follows an agile-inspired iterative lifecycle with lightweight phase gates suited to Class A software. Milestones are Requirements Baseline, Implementation Freeze, and System Test Complete. No architecture review or detailed design review gate is required, as these artifacts are not mandated for Class A.


[System] You are 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):

"The StepTrack requires structural coverage analysis including decision coverage for all modules."

[Assistant]
Verdict: FAIL
Note: Content mandates code coverage targets for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Coverage targets are Class B/C considerations. Class A has no coverage requirements.


[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 FleetTrack GPS Tracking Module, a Class A Fleet GPS Tracking Firmware. Reference IEC 62304 Clause 5.7.4.
Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

[Assistant] Content: The FleetTrack GPS Tracking Module traceability gap analysis identifies three types of gaps: unverified requirements, orphaned implementations, and unlinked test cases. Each gap is documented with a resolution plan and tracked to closure. Clause 5.7.4 verification of the Fleet GPS Tracking Firmware system test is not complete until all gaps are resolved.


[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):

"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 LabView Portal 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 LabView Portal.


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

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

"Detailed design for the MedInventory documents algorithms, data structures, and internal interfaces for each software unit per Clause 5.4.2."

[Assistant]
Verdict: FAIL
Note: Content mandates detailed design per Clause 5.4.2 for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Detailed design (Clause 5.4) is required only for Class C.


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

[User]
Write a SAD section on architectural overview for Class B for PulmoCheck Spirometry Analyzer, a Class B Spirometry Analysis Software. Reference IEC 62304 Clauses 5.3.1, 5.3.2.
Software analyzing spirometry data to calculate FEV1, FVC, and FEV1/FVC ratio with predicted value comparisons.

[Assistant] Content: The PulmoCheck Spirometry Analyzer architecture follows a layered design separating pneumotachograph data acquisition from processing logic and USB interface presentation. This decomposition isolates safety-relevant signal processing from non-critical display functions, supporting the Class B verification strategy of targeted integration testing at layer boundaries.


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

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

"The development plan references IEC 62304 Clause 5.6.8 and Clause Annex A.1 for the PhysioTrack Rehab."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.6.8 and Annex A.1, neither of which exists. Clause 5.6 has 5.6.1 through 5.6.7 only. IEC 62304 annexes are informative, not cited as requirements. All clause references must be corrected.


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

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

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

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "relevant standards", "established organizational procedures" provide no project-specific information about the PhysioTrack Rehab rehabilitation tracking system. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

[User]
Write a SRS section on data processing and transformation requirements for CalibrationTracker Equipment Logger, a Class A Calibration Record System. Reference IEC 62304 Clause 5.2.2.
Web application tracking calibration dates and results for medical test equipment. Administrative record keeping.

[Assistant] Content: Processing requirements for the CalibrationTracker Equipment Logger Calibration Record System cover data acquisition, filtering, computation, and presentation. Each processing step has specified input ranges, output tolerances, and error conditions. Data integrity is maintained throughout the processing pipeline.


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

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

"In accordance with ISO 13485-1, verification activities include system testing."

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

[User]
Write a SRS section on external system communication requirements for MedImage PACS Viewer, a Class A Web PACS Image Viewer. Reference IEC 62304 Clause 5.2.2.
Web-based PACS viewer enabling radiologists to review DICOM images with standard tools (windowing, measurement, MPR). View-only, no AI or diagnostic processing.

[Assistant] Content: The MedImage PACS Viewer Web PACS Image Viewer external communication requirements cover data exchange with remote systems. Each requirement specifies the message format, transport protocol, retry policy, and failure mode behavior, ensuring the Web PACS Image Viewer degrades safely if communication is disrupted.


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

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

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

[Assistant]
Description: Data retention in the PowerTrack UPS Monitor shall meet the specified minimum duration, with oldest records overwritten only after the retention period expires.
Rationale: Data retention supports clinical trend analysis and regulatory requirements for record keeping associated with the UPS Monitoring Software.
Priority: Mandatory
Acceptance Criterion: Oldest data record remains retrievable after continuous operation for the specified retention period.
Source: Regulatory


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

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

[Assistant] Content: The MindCalm Meditation Timer user interaction requirements define the observable behavior of the Meditation Wellness App from the user's perspective. Requirements are organized by use scenario and specify the information displayed, the timing of updates, and the user actions supported during Guided meditation timing with optional passive biometric display.


[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 safety requirements for Class B for BSACalc Body Surface Area Tool, a Class B BSA Calculator Web App. Reference IEC 62304 Clauses 5.2.2, 5.2.3.
Web calculator for body surface area using Mosteller and DuBois formulas. Used for chemotherapy dose calculations.

[Assistant] Content: The BSACalc Body Surface Area Tool Class B safety requirements include controls for data integrity, range validation, and fail-safe behavior when external system communication is lost. Each requirement traces to a hazard identified in the risk analysis and is verified during integration or system testing of the BSA Calculator Web App.


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

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

"Architectural design follows IEC 62304-6 Clause 5.3 for Class C devices."

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


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

[User]
Write a SDP section on internal SOPs and procedures for LabView Results Portal, a Class A Laboratory Results Viewer. Reference IEC 62304 Clause 5.1.2.
Web application displaying laboratory test results retrieved from the hospital LIS. Read-only viewer with no result interpretation or flagging.

[Assistant] Content: Internal procedures governing LabView Results Portal development include SOP-010 (Software Development Planning), SOP-011 (Risk Management Planning), SOP-012 (Configuration Management), and SOP-013 (Software Verification Planning). These standard operating procedures are maintained under the company's ISO 13485 quality management system and provide detailed work instructions for each lifecycle 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 WoundTrack (wound measurement imaging system, Class B):

"The WoundTrack software development conforms to ISO 62304, with risk management per ISO 14971:2019."

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

[User]
Write a SDP section on requirements elicitation and documentation for VisitorPass Access Management, a Class A Visitor Management System. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Kiosk application for visitor registration and badge printing in hospital lobbies. Administrative access control.

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


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

[User]
Expand requirement SRS-INTF-001: "clinical system integration interface" (Category: interface)
Project: LabStream LIS Middleware | Laboratory Information Middleware | Class A
Routing and auto-validating laboratory results between analyzers and the laboratory information system. Middleware software connecting laboratory analyzers to the hospital LIS. Routes results, applies auto-validation rules, and flags critical values.

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

[Assistant]
Description: Data interoperability with clinical information systems shall be provided through ASTM 1394, supporting standard message formats.
Rationale: External system connectivity is required for the Laboratory Information Middleware to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


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

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

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

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


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

[User]
Expand requirement SRS-FUNC-003: "power-on self-test sequence" (Category: functional)
Project: DoseCalc Medication Calculator | Medication Dose Calculator App | Class B
Calculating weight-based medication doses for clinical prescribing support. Mobile app calculating medication doses based on patient weight, age, and renal function. Incorrect calculations could cause underdosing or adverse effects.

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

[Assistant]
Description: A power-on self-test shall validate primary sensor communication, memory integrity, and manual data entry connectivity before the Medication Dose Calculator App transitions to its operational state.
Rationale: Startup verification prevents the Medication Dose Calculator App from operating with undetected faults that could affect output accuracy.
Priority: Mandatory
Acceptance Criterion: All fault injection scenarios are detected with 100% reliability across 50 test iterations.
Source: System requirement


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

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

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

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


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

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

"All verification for the wound measurement imaging system follows IEC 62304-5 requirements."

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


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

[User]
Write a SDP section on development methodology for Class C with full V-model for AnesBot Automated Anesthesia Controller, a Class C Automated Anesthesia Delivery Software. Reference IEC 62304 Clause 5.1.1.
Software controlling target-controlled infusion of propofol based on BIS monitoring. Overdose could cause respiratory arrest.

[Assistant] Content: The AnesBot Automated Anesthesia Controller follows a strict V-model lifecycle with no phase abbreviations permitted. Requirements trace to architecture, architecture traces to detailed design, and each trace is verified by independent reviewers. Unit testing with coverage targets, integration testing, and system testing form the ascending verification arm, each gated by formal review of the Automated Anesthesia Delivery Software test results.


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

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

"This plan is prepared in compliance with ISO 14901 and ISO 13485:2016."

[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 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 TempWatch Body Temperature Logger, a Class A Temperature Logging Firmware. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Firmware for a wearable temperature patch that logs skin temperature over 24 hours and displays trends. No fever detection or alerts.

[Assistant] Content: Documentation of TempWatch Body Temperature Logger 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 Temperature Logging Firmware during Passive logging and display of skin temperature trends for personal interest, severity and probability ratings, and references to applicable risk control measures.


[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):

"For the Class A CaloriePal, verification is limited to system-level test execution per Clause 5.7. The developer performs verification. No independent review is required. Test records include pass/fail results and defect references."

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


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

[User]
Expand requirement SRS-SAFE-002: "fail-safe behavior specification" (Category: safety)
Project: ChemoFlow Infusion Controller | Chemotherapy Infusion Pump Firmware | Class C
Precision-controlled chemotherapy drug infusion with dose-error detection and safety interlocks. Firmware for a chemotherapy infusion pump controlling precise drug delivery rates. Dosing errors could be life-threatening.

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

[Assistant]
Description: A deterministic safe-state transition shall be triggered by any detected critical fault condition in the ChemoFlow Infusion Controller, with all active outputs brought to a known safe configuration.
Rationale: Fail-safe behavior is essential to prevent the Chemotherapy Infusion Pump Firmware from causing harm when its software detects an unrecoverable error.
Priority: Mandatory
Acceptance Criterion: Safe state transition completes within the specified time limit for each defined critical fault, verified by fault injection during operation.
Source: Risk control


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

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

[Assistant] Content: The FleetTrack GPS Tracking Module development schedule is anchored to formal milestones with documented transition criteria. Progress is measured against these gates rather than calendar dates, ensuring the Fleet GPS Tracking Firmware meets all quality and safety requirements before advancing to the next lifecycle phase.


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

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

"All verification for the medical supply tracking system follows IEC 62304-5 requirements."

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


[System] You are a regulatory 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 DreamLog Sleep Monitor, a Class A Sleep Tracking Display App. Reference IEC 62304 Clause 5.2.2.
Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

[Assistant] Content: Functional requirements for the DreamLog Sleep Monitor are derived from the system requirements for Visualizing sleep quality data for personal wellness awareness and from risk control measures identified in the ISO 14971 analysis. Each requirement specifies a single function of the Sleep Tracking Display App with measurable acceptance criteria.