[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 RenalDose Renal Adjustment Calculator, a Class B Renal Dose Adjustment Calculator. Reference IEC 62304 Clause 5.2.2.
Calculator adjusting medication doses for patients with impaired renal function based on eGFR.

[Assistant] Content: External communication requirements for the RenalDose Renal Adjustment Calculator define the data exchange with systems outside the device boundary via lab results API. Requirements cover connection establishment, data transfer, error detection, and graceful degradation when the external system is unreachable during Calculating renal-adjusted medication doses based on estimated glomerular filtration rate.


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

[User]
Write a SDP section on cybersecurity and health IT standards for InhaleSense Smart Inhaler Tracker, a Class A Smart Inhaler Adherence Tracker. Reference IEC 62304 Clause 5.1.2.
Firmware for a smart inhaler attachment detecting actuation events, tracking medication adherence, and syncing data to a mobile app and clinician portal.

[Assistant] Content: Information security for the InhaleSense Smart Inhaler Tracker Smart Inhaler Adherence Tracker conforms to IEC 81001-5-1:2021, covering secure development practices, vulnerability disclosure, and post-market security monitoring. For devices incorporating electrical safety requirements, IEC 60601-1:2005+AMD2:2020 is referenced for programmable electrical medical system (PEMS) considerations.


[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):

"Risk control measures are implemented per IEC 14971 Clause 7."

[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 LabView Portal (read-only lab results viewer, Class A):

"REQ-SRS-078: The LabView Portal shall maintain data integrity during concurrent access by multiple users. No data corruption or loss shall occur. Acceptance criterion: execute concurrent read/write operations and verify data consistency. Priority: Mandatory. Source: System requirement."

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


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

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

"In accordance with IEC 62304:2022, verification activities include system testing."

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


[System] You are a regulatory 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 StepSync Activity Tracker, a Class A Wellness Activity Display App. Reference IEC 62304 Clauses 5.2.1, 5.2.2.
Mobile app displaying daily step count, distance, and calories from a wrist-worn accelerometer. Read-only display with no clinical interpretation.

[Assistant] Content: The StepSync Activity Tracker software requirements are captured in the SRS per Clause 5.2.1. Sources include system requirements for the Wellness Activity Display App, risk control measures from the ISO 14971 analysis, and regulatory requirements from the target markets. Each requirement is verifiable and traceable.


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

[User]
Write a SRS section on purpose of the SRS document for OBDView Diagnostic Display, a Class A Vehicle Diagnostic Display App. Reference IEC 62304 Clause 5.2.1.
Mobile app connecting to vehicle OBD-II port to display engine parameters, fault codes, and emissions data.

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


[System] You are 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):

"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 NeuroStim Programmer.


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

[User]
Write a SRS section on data format and interoperability requirements for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clause 5.2.2.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: Data exchanged by the CochleaMap CI Fitting Software via USB programming cable conforms to defined formats documented in this SRS. The Cochlear Implant Fitting Software validates incoming data against the format specification and rejects malformed messages with a logged error. Output data formats are deterministic and reproducible.


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

[User]
Write a SRS section on user interaction requirements for FallRisk Inpatient Assessment Tool, a Class B Fall Risk Assessment App. Reference IEC 62304 Clause 5.2.2.
Web app calculating fall risk scores for inpatients based on mobility, medication, and cognitive assessments.

[Assistant] Content: Interaction requirements for the FallRisk Inpatient Assessment Tool specify all user-facing behaviors of the Fall Risk Assessment App: screen layouts, navigation flows, alarm presentation (if applicable), and error messaging. Each interaction requirement includes the trigger condition, the expected system response, and the acceptance criteria for verification.


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

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

"The HeartLink development follows IEC 62304:2006+AMD1:2015 for the software lifecycle. Risk management is performed per ISO 14971:2019. The quality management system conforms to ISO 13485:2016."

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


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

[User]
Write a SRS section on operational context and user population for GaitSense Walking Analysis, a Class B Gait Analysis Insole Firmware. Reference IEC 62304 Clause 5.2.2.
Instrumented insole firmware analyzing gait patterns and detecting asymmetries. Reports generated for orthopedic assessment.

[Assistant] Content: The GaitSense Walking Analysis Gait Analysis Insole Firmware is deployed in an environment where Quantitative gait analysis using instrumented insoles for orthopedic and rehabilitation assessment. Users include trained clinical staff and, where applicable, patients or caregivers. The nRF52832 platform defines the computational environment, while BLE 5.0 provides the primary data communication pathway.


[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 follows ISO 13485-2 for the software lifecycle."

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


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

[User]
Write a SDP section on cybersecurity and health IT standards for NutriView Food Diary, a Class A Nutritional Tracking Display App. Reference IEC 62304 Clause 5.1.2.
Mobile app for manual food logging with nutritional summary display. No dietary recommendations or medical nutrition therapy.

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


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

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

"Software development follows IEC 62304 Clause 9.9 requirements for performance benchmarking."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 9.9 which does not exist. Clause 9 has 9.1 through 9.8 only. The reference must be corrected to a valid clause number.


[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: "user-configurable operating parameters" (Category: functional)
Project: RetinaScan Diabetic Retinopathy Screener | Retinal Screening Software | Class B
AI-assisted screening of retinal images for diabetic retinopathy signs, requiring specialist confirmation. Desktop software analyzing retinal fundus images to detect signs of diabetic retinopathy for ophthalmologist review.

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

[Assistant]
Description: The RetinaScan Diabetic Retinopathy Screener shall allow authorized users to configure operating parameters via DICOM and persist settings across power cycles.
Rationale: Configurable parameters allow the Retinal Screening Software to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: All configurable parameters persist correctly across power cycles and reject out-of-range values with appropriate error messages.
Source: User need


[System] You are a regulatory 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 VentAssist Pro (ICU ventilator controller, Class C):

"The VentAssist Pro addresses IEC 62304 Clause 5.1.12 for automated regression testing and Clause 6.4 for user acceptance testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.1.12 and 6.4, neither of which exists. Clause 5.1 has 5.1.1 through 5.1.11 only. Clause 6 has 6.1, 6.2, 6.3 only. All clause references must be corrected.


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

[User]
Expand requirement SRS-FUNC-004: "startup diagnostic verification" (Category: functional)
Project: TransVent Transport Ventilator | Transport Ventilator Firmware | Class C
Mechanical ventilation during patient transport in pre-hospital and inter-hospital settings. Portable transport ventilator firmware for ambulance and helicopter use. Must maintain ventilation under vibration and altitude changes.

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

[Assistant]
Description: Upon power-up, the TransVent Transport Ventilator shall execute a self-test sequence verifying the integrity of the turbine flow sensor interface, internal memory, and output subsystem before entering operational mode.
Rationale: A power-on self-test confirms hardware and software readiness before the Transport Ventilator Firmware begins use.
Priority: Mandatory
Acceptance Criterion: Self-test completes within the specified startup time and correctly detects each of the following injected faults: sensor disconnection, memory corruption, and display failure.
Source: System requirement


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

[User]
Write a SRS section on purpose of the SRS document for BeamPlan Radiation Treatment Planner, a Class C Radiation Treatment Planning Software. Reference IEC 62304 Clause 5.2.1.
Desktop software calculating radiation treatment plans including beam angles, dose distribution, and organ-at-risk constraints.

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


[System] You are a regulatory 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):

"Unit testing for the StepTrack shall use mutation testing to ensure test suite effectiveness, targeting a mutation score of at least 85%."

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


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

[User]
Write a FMEA section on failure mode identification approach for AssetTrack Equipment Inventory, a Class A Equipment Inventory System. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management only.

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


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

[User]
Write a SRS section on external system communication requirements for RetinaStim Visual Prosthesis Controller, a Class C Retinal Prosthesis Controller Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware driving a retinal implant electrode array based on camera input processing. Stimulation errors could cause retinal damage.

[Assistant] Content: The RetinaStim Visual Prosthesis Controller communicates with external systems via external camera. Requirements specify authentication, data encryption, message integrity verification, and timeout handling. The Retinal Prosthesis Controller Firmware must continue safe operation if the external system is unavailable.


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

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

"The lifecycle processes for the WoundTrack comply with IEC 62304:2020."

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


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

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

"The lifecycle processes for the OxyPure Controller comply with IEC 62304-3."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304-3" which is incorrect. IEC 62304 has no Part 3. All references must be corrected.


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

[User]
Write a SAD section on architectural overview for Class B for WoundTrack Healing Analyzer, a Class B Wound Assessment App. Reference IEC 62304 Clauses 5.3.1, 5.3.2.
Mobile app photographing wounds and measuring area/perimeter over time to track healing progress for clinician review.

[Assistant] Content: The WoundTrack Healing Analyzer Wound Assessment App is structured as a three-tier architecture: data acquisition, processing, and presentation. Interfaces between tiers are defined per Clause 5.3.2 and serve as integration test points. The architecture supports Kotlin implementation on Android.


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

[User]
Expand requirement SRS-FUNC-002: "configuration persistence and validation" (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: Operating parameters of the Medication Dose Calculator App shall be user-configurable within validated ranges and stored in non-volatile memory.
Rationale: Configurable parameters allow the Medication Dose Calculator App to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: Configuration round-trip test: set, power-cycle, read-back for all parameters with 100% accuracy.
Source: User need


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

[User]
Write a FMEA section on documenting failure modes and their effects for AllergyCard Patient Allergy Viewer, a Class A Patient Allergy Display. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

[Assistant] Content: Documentation of AllergyCard Patient Allergy Viewer 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 Patient Allergy Display during Read-only display of patient allergy information at point of care, severity and probability ratings, and references to applicable risk control measures.


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

[User]
Write a SDP section on development platform and build infrastructure for SurgLog Procedure Documentation App, a Class A Surgical Documentation App. Reference IEC 62304 Clause 5.1.4.
Tablet app for surgeons to dictate and review surgical procedure notes. Documentation tool only, no clinical decision support.

[Assistant] Content: The SurgLog Procedure Documentation App build environment uses Swift on iPadOS. Continuous integration builds execute on every commit, ensuring early detection of compilation errors and regression failures. Toolchain versions are locked to the configuration baseline and recorded in the Software Configuration Management Plan.


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

[User]
Write a SDP section on hazard identification for the specific device for NeoVent Neonatal Ventilator, a Class C Neonatal Ventilator Firmware. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Neonatal ventilator firmware supporting CPAP, NIPPV, and conventional ventilation for extremely premature infants. Tidal volumes as low as 2 mL.

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


[System] You are 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 SurgiPlan 3D Surgical Planner, a Class B 3D Surgical Planning SaMD. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Desktop SaMD for orthopedic surgeons to plan joint replacement procedures on 3D CT reconstructions. Outputs implant sizing and positioning specifications.

[Assistant] Content: Failure modes for each SurgiPlan 3D Surgical Planner 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 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 GlucoSpot Continuous Glucose Display, a Class B CGM Display App. Reference IEC 62304 Clause 5.2.2.
Mobile app receiving and displaying continuous glucose monitor readings via BLE. Shows trends, time-in-range, and configurable glucose alerts.

[Assistant] Content: External dependencies of the GlucoSpot Continuous Glucose Display include the iOS/Android operating environment, input hardware, and BLE 5.0 (CGM receiver). The CGM Display App requirements assume these dependencies operate within their specified parameters; failure modes of external components are addressed in the risk analysis.


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

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

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

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


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

[User]
Review this documentation excerpt for the VentAssist Pro (ICU ventilator controller, Class C):

"Class C verification for the VentAssist Pro includes unit testing with statement coverage of at least 90%, branch coverage of at least 80%, and MC/DC coverage of at least 80% for safety-critical modules. Integration testing verifies all inter-unit interfaces. System-level verification is performed by independent personnel."

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


[System] You are a regulatory 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):

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

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


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

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

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

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the PacePilot (pacemaker programmer, 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 SDP section on safety classification process and documentation for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clause 4.3.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: Clause 4.3 of IEC 62304 requires classification of the CochleaMap CI Fitting Software based on the severity of harm that could result from software malfunction. The classification was performed in conjunction with the ISO 14971 risk analysis for the Cochlear Implant Fitting Software and is subject to re-evaluation if the intended use or risk profile changes per Clause 5.2.4.


[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 hazard identification for the specific device for ECGInsight Rhythm Interpreter, a Class B ECG Interpretation Service. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Cloud service analyzing 12-lead ECG recordings and generating preliminary rhythm interpretations for physician review.

[Assistant] Content: For the ECGInsight Rhythm Interpreter, potential software contributions to hazardous situations include input data corruption, processing algorithm errors, and DICOM ECG input communication failures. Each identified cause is evaluated for severity and probability, with risk control measures defined per Clause 7.2.1 and traced to software requirements.


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

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

"The RadBeam Planner integration test plan addresses Clause 5.6.1 through 5.6.7. Software units are integrated incrementally with testing at each step. Test content per Clause 5.6.4 covers data integrity, timing constraints, and fault tolerance. Test records meet Clause 5.6.7 requirements."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the RadBeam Planner (radiation therapy planning system, Class C). Standards references are accurate.


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

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

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

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


[System] You are an IEC 62304 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 LabStream LIS Middleware, a Class A Laboratory Information Middleware. Reference IEC 62304 Clause 4.3.
Middleware software connecting laboratory analyzers to the hospital LIS. Routes results, applies auto-validation rules, and flags critical values.

[Assistant] Content: The LabStream LIS Middleware 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 Laboratory Information Middleware intended use or risk profile trigger reclassification.


[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 StepSync Activity Tracker, a Class A Wellness Activity Display App. Reference IEC 62304 Clause 5.2.2.
Mobile app displaying daily step count, distance, and calories from a wrist-worn accelerometer. Read-only display with no clinical interpretation.

[Assistant] Content: The StepSync Activity Tracker user interaction requirements define the observable behavior of the Wellness Activity Display 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 Passive display of physical activity metrics for personal wellness tracking.


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

[User]
Write a SRS section on user interaction requirements for RoomBoard Digital Signage, a Class A Patient Room Digital Signage. Reference IEC 62304 Clause 5.2.2.
Hospital room digital signage displaying patient name, care team, and daily schedule. Display-only, no clinical data entry.

[Assistant] Content: The RoomBoard Digital Signage Patient Room Digital Signage presents information to the user via MQTT and accepts user input through defined interaction patterns. User interaction requirements are traceable to the usability engineering file per IEC 62366-1:2015+AMD1:2020.


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

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

"IEC 62304-1 Section 5.7 requires all software units to be verified."

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

"Per Clause 5.4.2, each software unit of the NurseCall Hub has detailed design documentation."

[Assistant]
Verdict: FAIL
Note: Content mandates detailed design documentation 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 TRACE section on traceability scope including risk controls for AutoPancreas Closed-Loop Glucose Controller, a Class C Artificial Pancreas Controller Firmware. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Artificial pancreas firmware integrating CGM readings with insulin pump delivery using a PID control algorithm. Life-sustaining closed-loop system.

[Assistant] Content: Traceability for the AutoPancreas Closed-Loop Glucose Controller Artificial Pancreas Controller Firmware covers all software requirements per Clause 5.7.1 and all software-implemented risk controls per Clause 7.3.2. The combined matrix provides a single view of verification completeness for functional and safety aspects.


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

[User]
Expand requirement SRS-INTF-001: "primary sensor interface protocol" (Category: interface)
Project: BrachyDose HDR Afterloader Controller | HDR Brachytherapy Afterloader Firmware | Class C
Controlling radioactive source stepping positions and dwell times for high-dose-rate brachytherapy. Firmware controlling high-dose-rate brachytherapy source positioning and dwell times. Source positioning errors cause lethal local radiation.

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 BrachyDose HDR Afterloader Controller shall communicate with the source position encoder via stepper motor driver, implementing error detection and recovery for communication failures.
Rationale: Reliable sensor communication is the foundation of the HDR Brachytherapy Afterloader Firmware data acquisition pipeline.
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 compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

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

"The lifecycle processes for the NurseCall Hub comply with IEC 14971."

[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 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-004: "real-time data presentation on X12 EDI" (Category: functional)
Project: BillingBridge Claims Processor | Claims Processing Service | Class A
Automated processing and submission of insurance claims. Backend service processing insurance claims from the hospital billing system. Financial processing only, no clinical data.

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

[Assistant]
Description: The BillingBridge Claims Processor display shall present current readings on X12 EDI within the specified maximum update latency.
Rationale: Timely display updates ensure the user observes current readings without perceiving lag.
Priority: Mandatory
Acceptance Criterion: Measured display update interval is within 10% of the specified refresh period across 100 consecutive update cycles.
Source: User need


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

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

"The RadBeam Planner Class C development lifecycle includes requirements analysis (Clause 5.2), architectural design (Clause 5.3), implementation, and multi-level verification. Integration testing per Clause 5.6 validates component interactions. System testing per Clause 5.7 verifies end-to-end functionality."

[Assistant]
Verdict: PASS
Note: Content correctly specifies full Class C rigor; limits verification to system testing per Clause 5.7. Standards references are accurate.


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

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

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

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


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

[User]
Expand requirement SRS-FUNC-005: "continuous data sampling from dosimeter badge reader" (Category: functional)
Project: DoseLog Radiation Badge Reader | Dosimetry Data Logger | Class A
Reading and archiving personal radiation exposure data from dosimeter badges. Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

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

[Assistant]
Description: The DoseLog Radiation Badge Reader shall continuously sample dosimeter badge reader 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 Reading and archiving personal radiation exposure data from dosimeter badges.
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 a medical device regulatory standards expert with comprehensive knowledge of IEC 62304, ISO 14971, ISO 13485, IEC 62366-1, IEC 82304-1, IEC 81001-5-1, IEC 60601-1 and its sub-parts, and associated regulatory guidance. Provide accurate standards references. Never fabricate clause numbers or standard sub-parts.

[User] Does Class A require architectural documentation?

[Assistant] No. Software architectural design documentation (Clause 5.3) is NOT required for IEC 62304 Class A. It becomes required at Class B. Class A requires only development planning (5.1), requirements analysis (5.2), system testing (5.7), and release (5.8).


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

[Assistant] Content: Functional requirements for the SurgiPlan 3D Surgical Planner specify the data processing, user interaction, and output generation capabilities of the 3D Surgical Planning SaMD. Each requirement describes a discrete function the software shall perform during Preoperative 3D planning of joint replacement procedures with implant sizing and alignment, with acceptance criteria sufficient to derive verification test cases.


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

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

"Risk management for the ChemoCalc follows Clause 7. Software items contributing to hazardous situations are identified per Clause 7.1.1. Risk control measures are defined per Clause 7.2.1 and verified per Clause 7.3.1. Traceability is documented per Clause 7.3.2."

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


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

[User]
Write a SAD section on external interface architecture for PulmoCheck Spirometry Analyzer, a Class B Spirometry Analysis Software. Reference IEC 62304 Clause 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 isolates external dependencies behind abstraction interfaces per Clause 5.3.2. The USB and desktop GUI communication interfaces are accessed through adapter modules that translate protocol-specific details into the internal data model of the Spirometry Analysis Software.


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

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

"Each ThermoGuard software unit has a detailed design specification reviewed before implementation."

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

[User]
Write a SDP section on cybersecurity and health IT standards for PhysioTrack Rehabilitation Monitor, a Class B Physical Therapy Tracking System. Reference IEC 62304 Clause 5.1.2.
Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

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


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

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

"Code coverage analysis is mandatory for the SleepWell with minimum 85% line coverage."

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

[User]
Write a SDP section on change control process for OBDView Diagnostic Display, a Class A Vehicle Diagnostic Display App. Reference IEC 62304 Clauses 8.2, 8.2.1.
Mobile app connecting to vehicle OBD-II port to display engine parameters, fault codes, and emissions data.

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


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

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

"The ThermoGuard architecture is defined. The ThermoGuard architecture is documented. The ThermoGuard architecture is verified. The ThermoGuard architecture is reviewed. The ThermoGuard architecture is approved."

[Assistant]
Verdict: FAIL
Note: The documentation section exhibits repeated project name. The project name 'ThermoGuard' appears excessively. Sentences repeat the same assertion about the body temperature logger in different words. Content should be consolidated and each sentence should contribute unique, specific information about the ThermoGuard.


[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 AutoDose TPN (total parenteral nutrition calculator, Class C):

"The lifecycle processes for the AutoDose TPN comply with IEC 62304-2."

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


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

[User]
Write a SRS section on purpose of the SRS document for CalibrationTracker Equipment Logger, a Class A Calibration Record System. Reference IEC 62304 Clause 5.2.1.
Web application tracking calibration dates and results for medical test equipment. Administrative record keeping.

[Assistant] Content: This Software Requirements Specification defines the functional, performance, and interface requirements for the CalibrationTracker Equipment Logger Calibration Record System. Requirements are derived from system requirements, the risk management file, and stakeholder needs analysis per IEC 62304 Clause 5.2.1. Each requirement is uniquely identified, prioritized, and traceable to its source.


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

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

"The StepTrack architecture identifies segregation necessary for risk control per Clause 5.3.5."

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


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

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

"The software is released. The release is documented. The release is verified. The release package is prepared. The release is approved. The RadView DICOM software release follows the process."

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


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

[User]
Write a SDP section on SOUP identification and management for SterilLog Sterilization Record System, a Class A Sterilization Record Logger. Reference IEC 62304 Clause 8.1.2.
Software logging sterilization cycle parameters from autoclaves. Records temperature, pressure, and time for compliance documentation.

[Assistant] Content: SOUP components in the SterilLog Sterilization Record System are catalogued per Clause 8.1.2 with title, version, supplier, and license terms. The risk management process evaluates each SOUP item's known anomaly list per Clause 7.1.3 to determine whether any published defect could contribute to a hazardous situation in the Sterilization Record Logger.


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

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

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


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

[User]
Write a SDP section on hazard identification for the specific device for PostureGuard Desk Monitor, a Class A Posture Wellness Display Software. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
USB webcam software that estimates sitting posture and displays a wellness score. No ergonomic prescriptions or clinical assessments.

[Assistant] Content: Software-related hazard causes for the PostureGuard Desk Monitor Posture Wellness Display Software are documented per Clause 7.1.2 and Clause 7.1.4. Risk control measures per Clause 7.2.1 address each identified cause through input validation, range checking, communication integrity verification, and fail-safe defaults.


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

[User]
Write a SAD section on SOUP component integration and requirements for WaveReview EEG Archive Viewer, a Class A EEG Archive Viewer. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Desktop application for reviewing archived EEG recordings. Playback and waveform display only, no seizure detection.

[Assistant] Content: SOUP integration in the WaveReview EEG Archive Viewer architecture follows Clause 5.3.3 and Clause 5.3.4. Each SOUP item has documented functional requirements, performance requirements, and platform dependencies. The EEG Archive Viewer architecture ensures SOUP components are isolated behind defined interfaces to limit the impact of SOUP defects.


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

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

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

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


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

[User]
Write a SDP section on change control process for PedDose Pediatric Dosing App, a Class B Pediatric Dosing Calculator App. Reference IEC 62304 Clauses 8.2, 8.2.1.
Mobile reference app for pediatric drug dosing with weight-based calculations and age-specific ranges.

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


[System] You are a regulatory 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 B for TeleRehab Remote Patient Monitor, a Class B Remote Rehabilitation Platform. Reference IEC 62304 Clause 5.1.1.
Platform enabling remote physiotherapy with video consultations and wearable sensor data streaming. Generates exercise adherence reports.

[Assistant] Content: Development of the TeleRehab Remote Patient Monitor proceeds through a V-model lifecycle where each development phase has a paired verification phase. For Class B, the mandatory verification phases are architecture verification, integration testing, and system testing. Detailed design verification is omitted, as Clause 5.4 activities are not required at this classification level.


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

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

"The PillRemind integration test suite validates all APIs, shared memory interfaces, and IPC mechanisms between software items."

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


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

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

"System test procedures for the RadView DICOM are derived from the software requirements specification. Each test has defined preconditions, steps, and expected results. This is the only verification level required for Class A software."

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


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

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

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

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


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

[User] Is IEC 14971 a valid standard reference?

[Assistant] No. The correct prefix is ISO, not IEC. The standard is ISO 14971:2019, published by the International Organization for Standardization (ISO).


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

[User]
Expand requirement SRS-FUNC-002: "device configuration management" (Category: functional)
Project: PharmLog Medication History Viewer | Medication History Viewer | Class A
Read-only display of medication dispensing history. Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

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

[Assistant]
Description: Operating parameters of the Medication History Viewer shall be user-configurable within validated ranges and stored in non-volatile memory.
Rationale: Configurable parameters allow the Medication History Viewer to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: Configuration round-trip test: set, power-cycle, read-back for all parameters with 100% accuracy.
Source: User need


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

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

"This plan is prepared in compliance with IEC 62304:2015 and ISO 13485:2016."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62304:2015" which is incorrect. Wrong citation. Correct: IEC 62304:2006+AMD1:2015 (base standard from 2006, Amendment 1 in 2015). All references must be corrected.


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

[User]
Write a SRS section on external system communication requirements for PainRelief PCA Pump Controller, a Class C PCA Pump Controller Firmware. Reference IEC 62304 Clause 5.2.2.
Patient-controlled analgesia pump firmware allowing patient-initiated doses within physician-set limits. Overdose prevention is safety-critical.

[Assistant] Content: Requirements for external system integration with the PainRelief PCA Pump Controller specify the API contracts, data formats, and error handling behavior for all outbound communication from the PCA Pump Controller Firmware. The software must handle connection timeouts, malformed responses, and authentication failures without affecting safety-relevant functions.


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

[User]
Write a SRS section on baseline security requirements for PhysioTrack Rehabilitation Monitor, a Class B Physical Therapy Tracking System. Reference IEC 62304 Clause 5.2.2.
Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

[Assistant] Content: Baseline security requirements for the PhysioTrack Rehabilitation Monitor ensure the Physical Therapy Tracking System protects user data, resists unauthorized access, and maintains audit trails. Data communicated via cloud API is encrypted. Access is controlled through authentication mechanisms appropriate to the deployment environment.


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

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

"The RadBeam Planner addresses IEC 62304 Clause 7.5 (data archival) through formal review."

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


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

[User]
Expand requirement SRS-FUNC-003: "display update rate for Balance Training Platform Firmware" (Category: functional)
Project: BalanceBoard Vestibular Trainer | Balance Training Platform Firmware | Class B
Measuring postural sway and providing visual biofeedback during vestibular rehabilitation. Force plate firmware measuring center-of-pressure excursions during balance exercises. Provides real-time visual biofeedback.

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

[Assistant]
Description: Output presentation on the USB shall refresh at the configured interval, reflecting the most recent processed data from the Balance Training Platform Firmware pipeline.
Rationale: Display freshness is critical for the Balance Training Platform Firmware to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: Measured display update interval is within 10% of the specified refresh period across 100 consecutive update cycles.
Source: User need


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

[User]
Write a SRS section on latency and throughput requirements for PhysioTrack Rehabilitation Monitor, a Class B Physical Therapy Tracking System. Reference IEC 62304 Clause 5.2.2.
Wearable system tracking range-of-motion and exercise repetitions during physical therapy sessions. Generates progress reports for therapists.

[Assistant] Content: Performance requirements for the PhysioTrack Rehabilitation Monitor specify maximum latencies, throughput rates, and resource consumption limits for the Physical Therapy Tracking System operating on nRF52840 + web dashboard. Latency requirements define the maximum time from input event to output response for each critical processing path during Tracking exercise performance and range of motion during physical therapy for therapist review.


[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 latency and throughput requirements for ChemoFlow Infusion Controller, a Class C Chemotherapy Infusion Pump Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware for a chemotherapy infusion pump controlling precise drug delivery rates. Dosing errors could be life-threatening.

[Assistant] Content: Timing requirements for the ChemoFlow Infusion Controller include end-to-end latency from sensor acquisition to display update, processing throughput for sustained data streams, and startup time. Each timing requirement has a specific numeric bound and is verified through system testing of the Chemotherapy Infusion Pump 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 EchoAssist (echocardiogram analysis aid, Class B):

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

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


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

[User]
Write a SAD section on external interface architecture for PainRelief PCA Pump Controller, a Class C PCA Pump Controller Firmware. Reference IEC 62304 Clause 5.3.2.
Patient-controlled analgesia pump firmware allowing patient-initiated doses within physician-set limits. Overdose prevention is safety-critical.

[Assistant] Content: The PainRelief PCA Pump Controller architecture isolates external dependencies behind abstraction interfaces per Clause 5.3.2. The motor driver and LCD communication interfaces are accessed through adapter modules that translate protocol-specific details into the internal data model of the PCA Pump Controller 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 GlucoTrack CGM (continuous glucose monitor display, Class B):

"Documentation is prepared in accordance with standard templates and guidelines. Review cycles are established at appropriate intervals for the continuous glucose monitor display."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "appropriate intervals" provide no project-specific information about the GlucoTrack CGM continuous glucose monitor display. 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 external system communication requirements for TriagePro Emergency Scoring App, a Class B Emergency Department Triage SaMD. Reference IEC 62304 Clause 5.2.2.
Standalone tablet app implementing Manchester Triage System scoring. Guides clinicians through triage flowchart and records patient acuity level.

[Assistant] Content: The TriagePro Emergency Scoring App communicates with external systems via barcode scanner. Requirements specify authentication, data encryption, message integrity verification, and timeout handling. The Emergency Department Triage SaMD must continue safe operation if the external system is unavailable.


[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 LabView Results Portal, a Class A Laboratory Results Viewer. Reference IEC 62304 Clause 5.1.1.
Web application displaying laboratory test results retrieved from the hospital LIS. Read-only viewer with no result interpretation or flagging.

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


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

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

"Verification activities follow IEC 62304 Clause 5.9 for performance benchmarking."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.9 which does not exist. Clause 5 ends at 5.8. The reference must be corrected to a valid clause number.


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

[User]
Write a SRS section on functional requirements overview for VisitorPass Access Management, a Class A Visitor Management System. Reference IEC 62304 Clause 5.2.2.
Kiosk application for visitor registration and badge printing in hospital lobbies. Administrative access control.

[Assistant] Content: The VisitorPass Access Management functional requirements define what the Visitor Management System 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 requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

[User]
Expand requirement SRS-SAFE-001: "hardware watchdog safety mechanism" (Category: safety)
Project: InsuPrecise Insulin Pump Controller | Insulin Pump Controller Firmware | Class C
Automated insulin delivery control with programmable basal rates and bolus calculations. Embedded firmware controlling insulin delivery in a patch-type insulin pump. Incorrect dosing could cause severe hypoglycemia or diabetic ketoacidosis.

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

[Assistant]
Description: A dedicated watchdog timer shall monitor the InsuPrecise Insulin Pump Controller execution and initiate a controlled restart if the main loop fails to complete within its timing window.
Rationale: An independent watchdog provides a hardware-level safety net against software hang conditions in the Insulin Pump Controller Firmware.
Priority: Mandatory
Acceptance Criterion: Watchdog independence verified: main processor halt results in watchdog-initiated recovery within timing specification.
Source: Risk control


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

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

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

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the LabView Portal (read-only lab results viewer, Class A). 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: "absence of safety-critical functions" (Category: safety)
Project: AuditTrail QMS Event Logger | QMS Audit Trail Service | Class A
Capturing and archiving QMS events for regulatory audit trails. Microservice capturing and storing quality management system audit events. Logging and reporting only.

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

[Assistant]
Description: The AuditTrail QMS Event Logger software shall not implement any function that could directly control a therapeutic output, modify a diagnostic conclusion, or trigger a clinical alert, consistent with its Class A classification.
Rationale: Confirming the absence of safety-relevant functions validates the Class A classification under IEC 62304 Clause 4.3.
Priority: Mandatory
Acceptance Criterion: Architecture review demonstrates complete absence of safety-critical software functions in the QMS Audit Trail Service.
Source: Regulatory


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

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

"The GlucoTrack CGM architectural design identifies software items and their boundaries. Each interface is documented with data types, ranges, and error conditions. Segregation for risk control is identified per Clause 5.3.5. SOUP items are specified per Clause 5.3.3 and 5.3.4."

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


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

[User]
Expand requirement SRS-INTF-001: "external system data exchange" (Category: interface)
Project: DialyFlow Dialysis Fluid Controller | Hemodialysis Fluid Controller Firmware | Class C
Controlling dialysate composition, flow rates, and ultrafiltration in hemodialysis. Firmware controlling dialysate flow rates and composition in a hemodialysis machine. Fluid balance errors could be fatal.

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 Hemodialysis Fluid Controller Firmware shall support bidirectional data exchange with external systems over CAN bus.
Rationale: External system connectivity is required for the Hemodialysis Fluid Controller Firmware to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


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

[User]
Write a SDP section on safety classification process and documentation for NeoFeed Neonatal Feeding Pump, a Class C Neonatal Feeding Pump Firmware. Reference IEC 62304 Clause 4.3.
Syringe pump firmware for precise enteral feeding in NICU patients. Flow accuracy is critical for extremely low birth weight infants.

[Assistant] Content: Clause 4.3 of IEC 62304 requires classification of the NeoFeed Neonatal Feeding Pump based on the severity of harm that could result from software malfunction. The classification was performed in conjunction with the ISO 14971 risk analysis for the Neonatal Feeding Pump Firmware and is subject to re-evaluation if the intended use or risk profile changes per Clause 5.2.4.


[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):

"Per IEC 62304, the PhysioTrack Rehab software requirements are documented. Per IEC 62304, all requirements for the PhysioTrack Rehab are captured. Per IEC 62304, the requirements are recorded in the SRS. Per IEC 62304, each requirement is traceable to its source."

[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 PhysioTrack Rehab.


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

[User]
Expand requirement SRS-INTF-002: "external system data exchange" (Category: interface)
Project: PowerTrack UPS Monitor | UPS Monitoring Software | Class A
Logging and displaying UPS status for facility infrastructure monitoring. Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

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

[Assistant]
Description: The UPS Monitoring Software shall support bidirectional data exchange with external systems over SNMP.
Rationale: External system connectivity is required for the UPS Monitoring Software to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


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

[User]
Write a SDP section on verification strategy for Class C -- unit, integration, and system with coverage for RetinaStim Visual Prosthesis Controller, a Class C Retinal Prosthesis Controller Firmware. Reference IEC 62304 Clauses 5.5, 5.5.2, 5.6, 5.7.
Firmware driving a retinal implant electrode array based on camera input processing. Stimulation errors could cause retinal damage.

[Assistant] Content: Verification of the RetinaStim Visual Prosthesis Controller at Class C mandates unit-level testing with quantitative coverage targets: statement >= 90%, branch >= 80%, MC/DC >= 80%. Integration testing confirms correct data exchange between the software items defined in the architecture. System testing validates the Retinal Prosthesis Controller Firmware end-to-end against the SRS. All verification activities undergo independent review.


[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):

"The WoundTrack software development conforms to IEC 62304-2, with risk management per ISO 14971:2019."

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


[System] You are 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 ScreenFlow Population Health Screener, a Class A Serverless Population Health Screening SaMD. Reference IEC 62304 Clause 5.1.1.
Serverless cloud application processing population-level health screening questionnaires and flagging individuals for follow-up based on risk scoring algorithms.

[Assistant] Content: For the Class A ScreenFlow Population Health Screener, 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 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: "data integrity validation" (Category: data)
Project: SterilLog Sterilization Record System | Sterilization Record Logger | Class A
Recording and archiving sterilization cycle parameters for regulatory compliance. Software logging sterilization cycle parameters from autoclaves. Records temperature, pressure, and time for compliance documentation.

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

[Assistant]
Description: Data integrity of all stored records in the Sterilization Record Logger shall be verified using CRC or equivalent checksums upon read-back.
Rationale: Corrupted data must be identified to prevent clinical decisions based on unreliable measurements.
Priority: Mandatory
Acceptance Criterion: Integrity check correctly identifies all corrupted records with zero false positives on uncorrupted data.
Source: System requirement


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

[User]
Write a TRACE section on risk control coverage verification for CalibrationTracker Equipment Logger, a Class A Calibration Record System. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Web application tracking calibration dates and results for medical test equipment. Administrative record keeping.

[Assistant] Content: Coverage analysis for risk controls in the CalibrationTracker Equipment Logger per Clause 7.3.2 ensures no software-implemented control lacks verification evidence. The analysis cross-references the risk management file with the traceability matrix and the test results to confirm complete coverage for the Calibration Record System.