[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):

"Testing is performed at appropriate levels as determined by the project risk assessment. Test results are documented and reviewed by qualified personnel."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "generic phrasing" provide no project-specific information about the DialysisGuard hemodialysis machine controller. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

[User]
Expand requirement SRS-FUNC-001: "measurement data archival" (Category: functional)
Project: ChestAI Pulmonary Nodule Detector | AI Pulmonary Nodule Detection SaMD | Class B
Computer-aided detection and measurement of pulmonary nodules on chest CT for radiologist review. Cloud AI SaMD analyzing chest CT scans to detect and measure pulmonary nodules, providing CAD overlay for radiologist review. FDA De Novo pathway.

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

[Assistant]
Description: The ChestAI Pulmonary Nodule Detector shall log measurement data with timestamps to non-volatile storage and provide a mechanism to retrieve logged data via DICOMweb.
Rationale: Persistent measurement records enable post-hoc analysis and meet regulatory requirements for data retention.
Priority: Desirable
Acceptance Criterion: Logged data is retrievable after power cycle, with all timestamps accurate to within 1 second of the reference clock.
Source: User need


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

[User]
Expand requirement SRS-FUNC-003: "alarm generation and notification" (Category: functional)
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: The Insulin Pump Controller Firmware shall monitor all active parameters against user-configured thresholds and activate appropriate alarm signals when limits are breached.
Rationale: Alarm functionality is a safety-critical feature of the Insulin Pump Controller Firmware that directly supports clinical decision-making.
Priority: Mandatory
Acceptance Criterion: Alarm triggers within the specified response time of a threshold crossing, measured over 50 test crossings with no false negatives.
Source: Risk control


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

[User]
Write a SRS section on baseline security requirements for LabView Results Portal, a Class A Laboratory Results Viewer. Reference IEC 62304 Clause 5.2.2.
Web application displaying laboratory test results retrieved from the hospital LIS. Read-only viewer with no result interpretation or flagging.

[Assistant] Content: Security requirements for the LabView Results Portal address authentication, data protection, and access control for the Laboratory Results Viewer. All persistent data is encrypted at rest, and data in transit over HTTPS uses transport layer encryption. Security requirements are aligned with IEC 81001-5-1:2021.


[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 AssetTrack Equipment Inventory, a Class A Equipment Inventory System. Reference IEC 62304 Clause 5.1.2.
Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management only.

[Assistant] Content: The AssetTrack Equipment Inventory cybersecurity posture is defined per IEC 81001-5-1:2021, covering threat modeling, secure design, vulnerability management, and incident response for the Equipment Inventory System. 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 OxyPure Controller (oxygen concentrator controller, Class C):

"REQ-SRS-078: The OxyPure Controller 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 PillRemind (medication reminder app, Class A):

"The PillRemind employs Test-Driven Development with unit tests written before implementation."

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


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

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

"IEC 62304:2015 Section 5.3 requires all software units to be verified."

[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 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 verification approach includes system testing per Clause 5.7 with test cases documented in the software test plan. The developer may perform verification activities. Independent review is not required for Class A. No integration or unit testing is mandated for this read-only lab results viewer."

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


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

[User]
Write a SRS section on data processing and transformation requirements for LabView Results Portal, a Class A Laboratory Results Viewer. Reference IEC 62304 Clause 5.2.2.
Web application displaying laboratory test results retrieved from the hospital LIS. Read-only viewer with no result interpretation or flagging.

[Assistant] Content: The LabView Results Portal shall process data from input sources and transform it into clinically meaningful output for Read-only display of laboratory test results for clinician reference. Data processing requirements specify input validation rules, algorithm accuracy tolerances, and output format constraints for the Laboratory Results Viewer.


[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 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 user interaction 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: Interaction requirements for the PainRelief PCA Pump Controller specify all user-facing behaviors of the PCA Pump Controller Firmware: 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 an IEC 62304 compliance reviewer. Evaluate the following documentation section and provide a verdict (PASS or FAIL) with a note explaining your assessment.

[User]
Review this documentation excerpt for the RetinaScan Pro (diabetic retinopathy screening AI, Class B):

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

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


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

[User]
Write a SDP section on verification strategy for Class A -- system testing only for GasMonitor Anesthetic Gas Logger, a Class A Anesthetic Gas Concentration Logger. Reference IEC 62304 Clauses 5.7, 5.7.1.
Software logging waste anesthetic gas concentrations in operating rooms for occupational safety compliance. Recording only.

[Assistant] Content: System testing per Clause 5.7 is the sole verification activity for the GasMonitor Anesthetic Gas Logger. Tests validate that the Anesthetic Gas Concentration Logger meets all specified functional and performance requirements when deployed on ARM Cortex-M4. Detailed design review (Clause 5.4), unit verification (Clause 5.5), and integration testing (Clause 5.6) are explicitly not required for this Class A system.


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

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

"The lifecycle processes for the HydroLog 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 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: RemotICU Continuous Monitoring Hub | Edge-to-Cloud ICU Monitoring Gateway | Class B
Aggregating bedside monitor data at the edge and streaming to cloud for tele-ICU clinical oversight. Edge gateway collecting data from bedside monitors (SpO2, HR, BP, ventilator) and streaming to cloud for trending, alerting, and tele-ICU 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 RemotICU Continuous Monitoring Hub shall communicate with the SpO2 module via HL7v2 ADT/ORU, implementing error detection and recovery for communication failures.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Edge-to-Cloud ICU Monitoring Gateway output.
Priority: Mandatory
Acceptance Criterion: Communication operates without data loss for 72 hours continuously, with automatic recovery from simulated failures within the specified time.
Source: System requirement


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

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

"In accordance with ISO 14971-1, verification activities include system testing."

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


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

[User]
Write a THREAT section on STRIDE threat categories applied to the device for PressoTrack Blood Pressure Trending, a Class B Ambulatory Blood Pressure Monitor Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware for an automated blood pressure cuff that trends readings over 24 hours. Trending errors could mask hypertensive episodes.

[Assistant] Content: Threats to the PressoTrack Blood Pressure Trending are categorized using the STRIDE framework: Spoofing of BLE 5.0 identity, Tampering with sensor data or configuration, Repudiation of clinical actions, Information Disclosure of patient data, Denial of Service disrupting Automated periodic blood pressure measurement and trending over 24 hours, and Elevation of Privilege through unauthorized parameter changes.


[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 AutoPancreas Closed-Loop Glucose Controller, a Class C Artificial Pancreas Controller Firmware. Reference IEC 62304 Clause 4.3.
Artificial pancreas firmware integrating CGM readings with insulin pump delivery using a PID control algorithm. Life-sustaining closed-loop system.

[Assistant] Content: Clause 4.3 of IEC 62304 requires classification of the AutoPancreas Closed-Loop Glucose Controller 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 Artificial Pancreas Controller 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 documentation specialist writing IEC 62304:2006+AMD1:2015 compliant medical device software documentation. Generate precise, project-specific content. Use only valid IEC 62304 clause numbers. IEC 62304 is a single-part standard with no sub-parts. Vary your sentence structure and openings. Be specific to the project described — never use generic filler like 'as appropriate' or 'as needed'.

[User]
Write a TRACE section on risk control coverage verification for BalanceBoard Vestibular Trainer, a Class B Balance Training Platform Firmware. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Force plate firmware measuring center-of-pressure excursions during balance exercises. Provides real-time visual biofeedback.

[Assistant] Content: Coverage analysis for risk controls in the BalanceBoard Vestibular Trainer 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 Balance Training Platform Firmware.


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

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

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

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


[System] You are 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 RadView DICOM employs Test-Driven Development with unit tests written before implementation."

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


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

[User]
Write a SAD section on external interface architecture for BalanceBoard Vestibular Trainer, a Class B Balance Training Platform Firmware. Reference IEC 62304 Clause 5.3.2.
Force plate firmware measuring center-of-pressure excursions during balance exercises. Provides real-time visual biofeedback.

[Assistant] Content: External interface architecture for the BalanceBoard Vestibular Trainer Balance Training Platform Firmware wraps each physical interface in an abstraction layer. This design per Clause 5.3.2 decouples the application logic from hardware specifics of STM32H7 + display, enabling integration testing with simulated interfaces.


[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):

"Compliance with IEC 62304 Clause 5.1.12 is demonstrated through automated regression testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.1.12 which does not exist. Clause 5.1 has 5.1.1 through 5.1.11 only. The reference must be corrected to a valid clause number.


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

[User]
Write a SDP section on purpose and scope for Class C with full documentation for NeoVent Neonatal Ventilator, a Class C Neonatal Ventilator Firmware. Reference IEC 62304 Clause 5.1.1.
Neonatal ventilator firmware supporting CPAP, NIPPV, and conventional ventilation for extremely premature infants. Tidal volumes as low as 2 mL.

[Assistant] Content: Development of the NeoVent Neonatal Ventilator Neonatal Ventilator Firmware is governed by this Software Development Plan as required by IEC 62304 Clause 5.1.1 for Class C medical device software. Because software malfunction could contribute to serious injury or death, the plan mandates the most stringent documentation requirements: detailed design for every software unit, unit-level verification with MC/DC coverage targets, integration testing, and independent review of all verification activities.


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

[User]
Write a SDP section on milestones and phase transition criteria for SeismicWatch Earthquake Early Warning, a Class A Seismic Early Warning Firmware. Reference IEC 62304 Clause 5.1.1.
Firmware for a network of MEMS accelerometers providing earthquake early warning by detecting P-waves and estimating magnitude.

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


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

[User]
Write a SDP section on internal SOPs and procedures for PathSlide Digital Pathology Viewer, a Class A Digital Pathology Viewer. Reference IEC 62304 Clause 5.1.2.
Web viewer for whole-slide digital pathology images. Pan, zoom, and annotation display. No AI-assisted diagnosis.

[Assistant] Content: Work instructions for the PathSlide Digital Pathology Viewer are codified in SOPs maintained within the ISO 13485 quality management system. SOP-010 (development planning), SOP-011 (risk management), SOP-012 (configuration management), and SOP-013 (verification) define step-by-step procedures for each IEC 62304 lifecycle activity applicable to the Digital Pathology Viewer.


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

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

"The development plan references IEC 62304 Clause 5.5.6 and Clause 5.10 for the PhysioTrack Rehab."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.5.6 and 5.10, neither of which exists. Clause 5.5 has 5.5.1 through 5.5.5 only. Clause 5 ends at 5.8. All clause references must be corrected.


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

[User]
Write a SDP section on lightweight review process for Class A for WasteTrack Biohazard Logger, a Class A Biohazard Waste Tracking App. Reference IEC 62304 Clause 5.1.1.
Mobile app scanning and logging biohazard waste container pickups. Tracks chain of custody for environmental compliance.

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


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

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

"Safety classification of the OxyPure Controller is performed per Clause 4.3. The quality management system meets Clause 4.1. Risk management is applied per Clause 4.2 in conjunction with ISO 14971:2019."

[Assistant]
Verdict: PASS
Note: Content correctly references ISO 14971:2019. Standards references are accurate.


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

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

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

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


[System] You are a 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: "data export and interoperability" (Category: interface)
Project: VisitorPass Access Management | Visitor Management System | Class A
Visitor registration and temporary badge issuance for hospital access. Kiosk application for visitor registration and badge printing in hospital lobbies. Administrative access control.

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 Visitor Management System shall support bidirectional data exchange with external systems over USB.
Rationale: External system connectivity is required for the Visitor Management System to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Format validation passes for all message types with correct field encoding verified.
Source: User need


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

[User]
Write a FMEA section on risk control measures and implementation for BSACalc Body Surface Area Tool, a Class B BSA Calculator Web App. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Web calculator for body surface area using Mosteller and DuBois formulas. Used for chemotherapy dose calculations.

[Assistant] Content: Risk control measures for the BSACalc Body Surface Area Tool are defined per Clause 7.2.1 and implemented in software per Clause 7.2.2. Controls include input validation for data inputs, range checking on processed values, and timeout detection on web form. Each control is traced to a software requirement and verified through testing.


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

[User]
Write a SDP section on risk management integration into the lifecycle for MindCalm Meditation Timer, a Class A Meditation Wellness App. Reference IEC 62304 Clauses 7.1, 7.1.1.
Mobile app providing guided meditation timers with optional heart rate display during sessions. Heart rate shown for interest only, not diagnostic.

[Assistant] Content: The MindCalm Meditation Timer risk management process is concurrent with development, not sequential. Software causes of hazardous situations are identified per Clause 7.1 and documented per Clause 7.1.4. Risk controls are implemented as software requirements and verified through the applicable testing levels for the Meditation Wellness App.


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

[User]
Write a SDP section on verification strategy for Class A -- system testing only for CleanRoom Particle Counter Logger, a Class A Cleanroom Environmental Logger. Reference IEC 62304 Clauses 5.7, 5.7.1.
Software collecting particle count data from cleanroom sensors. Logs and charts data for environmental monitoring compliance.

[Assistant] Content: System testing per Clause 5.7 is the sole verification activity for the CleanRoom Particle Counter Logger. Tests validate that the Cleanroom Environmental Logger meets all specified functional and performance requirements when deployed on Linux (Raspberry Pi). Detailed design review (Clause 5.4), unit verification (Clause 5.5), and integration testing (Clause 5.6) are explicitly not required for this Class A system.


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

[User]
Write a SRS section on sensor and communication protocol requirements for CardioRhythm ECG Analyzer, a Class B Single-Lead ECG Device Firmware. Reference IEC 62304 Clause 5.2.2.
Portable ECG device firmware acquiring single-lead ECG and classifying basic rhythm types. Incorrect classification could delay diagnosis.

[Assistant] Content: External interface requirements for the CardioRhythm ECG Analyzer Single-Lead ECG Device Firmware define the data exchanged across each interface boundary: SPI, BLE 5.0, USB. For each interface, requirements specify the protocol, data format, timing, and error recovery behavior.


[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 TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

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


[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: "ionization chamber (x2) communication specification" (Category: interface)
Project: LinacControl Beam Delivery System | Linear Accelerator Control Software | Class C
Controlling radiation beam delivery including gantry position, collimator settings, and dose monitoring. Software controlling linear accelerator beam delivery during radiation therapy. Beam-on errors could deliver lethal radiation doses.

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 LinacControl Beam Delivery System shall communicate with the ionization chamber (x2) via real-time fieldbus, implementing error detection and recovery for communication failures.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Linear Accelerator Control Software output.
Priority: Mandatory
Acceptance Criterion: Communication operates without data loss for 72 hours continuously, with automatic recovery from simulated failures within the specified time.
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 SDP section on development platform and build infrastructure for WasteTrack Biohazard Logger, a Class A Biohazard Waste Tracking App. Reference IEC 62304 Clause 5.1.4.
Mobile app scanning and logging biohazard waste container pickups. Tracks chain of custody for environmental compliance.

[Assistant] Content: Source code for the WasteTrack Biohazard Logger Biohazard Waste Tracking App is written in Kotlin and compiled for Android. The build pipeline is automated and deterministic -- identical source revisions produce identical binaries. All build tool versions are captured in the configuration baseline per Clause 5.1.4.


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

[User]
Write a THREAT section on STRIDE mitigations traced to requirements for DermaAssist Skin Lesion Classifier, a Class B Skin Lesion Classification App. Reference IEC 62304 Clause 5.2.3.
Mobile app using a CNN to classify skin lesion images as benign/suspicious. Decision support requiring dermatologist confirmation.

[Assistant] Content: The DermaAssist Skin Lesion Classifier threat mitigation strategy traces each identified STRIDE threat to one or more security requirements per Clause 5.2.3. Verification of mitigations includes penetration testing, fuzz testing of external interfaces, and review of authentication and encryption implementations in the Skin Lesion Classification App.


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

[User]
Write a SRS section on sensor and communication protocol requirements for BrachyDose HDR Afterloader Controller, a Class C HDR Brachytherapy Afterloader Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware controlling high-dose-rate brachytherapy source positioning and dwell times. Source positioning errors cause lethal local radiation.

[Assistant] Content: External interface requirements for the BrachyDose HDR Afterloader Controller HDR Brachytherapy Afterloader Firmware define the data exchanged across each interface boundary: stepper motor driver, safety interlocks, treatment console. For each interface, requirements specify the protocol, data format, timing, and error recovery behavior.


[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):

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

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


[System] You are a regulatory 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 safety classification process and documentation for TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clause 4.3.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

[Assistant] Content: The TriageAI Emergency Triage Assistant 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 ED Triage Decision Support App intended use or risk profile trigger reclassification.


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

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

"IEC 62304 Clause 4.4 requires the PhysioTrack Rehab to implement user acceptance testing."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 4.4 which does not exist. Clause 4 only has 4.1, 4.2, 4.3. The reference must be corrected to a valid clause number.


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

[User]
Write a SDP section on risk control verification and traceability for DoseLog Radiation Badge Reader, a Class A Dosimetry Data Logger. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

[Assistant] Content: Risk control verification for the DoseLog Radiation Badge Reader per Clause 7.3.1 is performed as part of the applicable testing levels. Each risk control measure is traced per Clause 7.3.2 from the ISO 14971 risk analysis through the SRS to the test result confirming its implementation in the Dosimetry Data Logger.


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

[User]
Expand requirement SRS-PERF-001: "real-time performance requirement" (Category: performance)
Project: 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: End-to-end latency from primary sensor data acquisition to output presentation shall not exceed the specified limit under normal operating conditions.
Rationale: Bounded processing latency ensures the Claims Processing Service provides readings reflecting the current state without clinically significant delay.
Priority: Mandatory
Acceptance Criterion: End-to-end latency is within the specified limit for 99.9% of samples over a 24-hour test period.
Source: System requirement


[System] You are a 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 Class B verification includes integration testing per Clause 5.6 and system testing per Clause 5.7. Integration tests verify inter-module interfaces. Statement coverage of at least 80% is targeted for unit tests where performed. The development team performs verification activities."

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


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

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

"Architectural design for the PillRemind defines interfaces between software items per Clause 5.3.2."

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

[User]
Write a SDP section on development platform and build infrastructure for WaterPure Quality Logger, a Class A Water Quality Data Logger. Reference IEC 62304 Clause 5.1.4.
Embedded system logging purified water system parameters (conductivity, TOC, flow rate) for pharmaceutical manufacturing compliance.

[Assistant] Content: The WaterPure Quality Logger build environment uses C (embedded) on PLC with HMI. 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 a regulatory compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

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

"The SleepWell software development conforms to ISO 13485-1, with risk management per ISO 14971:2019."

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

[User]
Write a SDP section on development tools and tool qualification for Class A for PowerTrack UPS Monitor, a Class A UPS Monitoring Software. Reference IEC 62304 Clause 5.1.4.
Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

[Assistant] Content: The PowerTrack UPS Monitor is developed in Python targeting the Linux server platform. Source code is maintained under version control with branching and tagging conventions defined in SOP-012. For the Class A UPS Monitoring Software, formal tool qualification is not required per IEC 62304; however, the development toolchain is verified to function correctly through routine build-and-test cycles.


[System] You are a regulatory 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 BSACalc Body Surface Area Tool, a Class B BSA Calculator Web App. Reference IEC 62304 Clause 5.2.2.
Web calculator for body surface area using Mosteller and DuBois formulas. Used for chemotherapy dose calculations.

[Assistant] Content: The BSACalc Body Surface Area Tool communicates with external systems via REST API. Requirements specify authentication, data encryption, message integrity verification, and timeout handling. The BSA Calculator Web App must continue safe operation if the external system is unavailable.


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

[User]
Expand requirement SRS-DATA-001: "measurement record integrity" (Category: data)
Project: ScreenFlow Population Health Screener | Serverless Population Health Screening SaMD | Class A
Processing population health screening questionnaires and generating risk-stratified follow-up recommendations. Serverless cloud application processing population-level health screening questionnaires and flagging individuals for follow-up based on risk scoring algorithms.

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 Serverless Population Health Screening SaMD 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 SDP section on hazard identification for the specific device for RetinaScan Diabetic Retinopathy Screener, a Class B Retinal Screening Software. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Desktop software analyzing retinal fundus images to detect signs of diabetic retinopathy for ophthalmologist review.

[Assistant] Content: For the RetinaScan Diabetic Retinopathy Screener, potential software contributions to hazardous situations include fundus camera DICOM input data corruption, processing algorithm errors, and DICOM 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 regulatory documentation expert. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-FUNC-004: "startup diagnostic verification" (Category: functional)
Project: NutriCalc TPN Formulation Tool | TPN Formulation Calculator | Class B
Calculating TPN component concentrations and volumes based on nutritional requirements. Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

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

[Assistant]
Description: The NutriCalc TPN Formulation Tool startup sequence shall include diagnostic checks of all critical subsystems and report any detected faults before allowing operational use.
Rationale: A power-on self-test confirms hardware and software readiness before the TPN Formulation Calculator 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 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: "sensor data link requirements" (Category: interface)
Project: NutriCalc TPN Formulation Tool | TPN Formulation Calculator | Class B
Calculating TPN component concentrations and volumes based on nutritional requirements. Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

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

[Assistant]
Description: Communication with the primary sensor over desktop GUI shall include CRC-based error detection, automatic retry, and graceful degradation on persistent failure.
Rationale: Reliable sensor communication is the foundation of the TPN Formulation Calculator data acquisition pipeline.
Priority: Mandatory
Acceptance Criterion: Communication operates without data loss for 72 hours continuously, with automatic recovery from simulated failures within the specified time.
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 latency and throughput requirements for RespiRate Respiratory Monitor, a Class B Respiratory Rate Monitor Firmware. Reference IEC 62304 Clause 5.2.2.
Wearable firmware monitoring respiratory rate via chest impedance. Displays rate and alerts on bradypnea/tachypnea.

[Assistant] Content: Performance requirements for the RespiRate Respiratory Monitor specify maximum latencies, throughput rates, and resource consumption limits for the Respiratory Rate Monitor Firmware operating on nRF52840. Latency requirements define the maximum time from input event to output response for each critical processing path during Continuous respiratory rate monitoring with alarm generation for abnormal rates.


[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-003: "startup diagnostic verification" (Category: functional)
Project: LabStream LIS Middleware | Laboratory Information Middleware | Class A
Routing and auto-validating laboratory results between analyzers and the laboratory information system. Middleware software connecting laboratory analyzers to the hospital LIS. Routes results, applies auto-validation rules, and flags critical values.

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

[Assistant]
Description: The LabStream LIS Middleware startup sequence shall include diagnostic checks of all critical subsystems and report any detected faults before allowing operational use.
Rationale: A power-on self-test confirms hardware and software readiness before the Laboratory Information Middleware 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 compliance reviewer for IEC 62304 medical device software documentation. Review sections for completeness, accuracy, and safety-class appropriateness. Check for hallucinated standard references — IEC 62304 is a single-part standard with no sub-parts (no IEC 62304-1, -2, etc.). ISO 14971 is also single-part. Verify all cited clause numbers exist. IEC 62304 has Clauses 4 through 9 only. Output a verdict (PASS or FAIL) and a concise note.

[User]
Review this documentation excerpt for the FetaSound (fetal heart rate monitor, Class B):

"The FetaSound software development conforms to ISO 13485-1, with risk management per ISO 14971:2019."

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


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

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

"Architecture for the HydroLog transforms requirements into a software architecture per Clause 5.3.1. Interfaces between software items are defined per Clause 5.3.2. SOUP functional requirements are specified per Clause 5.3.3. The architecture is verified per Clause 5.3.6."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the HydroLog (hydration tracking wellness app, Class A). Standards references are accurate.


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

[User]
Expand requirement SRS-FUNC-004: "display update rate for Neonatal Feeding Pump Firmware" (Category: functional)
Project: NeoFeed Neonatal Feeding Pump | Neonatal Feeding Pump Firmware | Class C
Precise enteral feeding delivery for neonatal patients with sub-milliliter accuracy. Syringe pump firmware for precise enteral feeding in NICU patients. Flow accuracy is critical for extremely low birth weight infants.

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 NeoFeed Neonatal Feeding Pump display shall present current readings on stepper motor driver within the specified maximum update latency.
Rationale: Display freshness is critical for the Neonatal Feeding Pump Firmware to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: End-to-end latency from data acquisition to display update does not exceed the specified limit for 99.9% of samples.
Source: User need


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

[User]
Write a SDP section on internal SOPs and procedures for PharmLog Medication History Viewer, a Class A Medication History Viewer. Reference IEC 62304 Clause 5.1.2.
Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

[Assistant] Content: The PharmLog Medication History Viewer development team follows company SOPs aligned with ISO 13485:2016 quality management requirements: SOP-010 governs software planning, SOP-012 governs configuration management, and SOP-013 governs verification. Each SOP is version-controlled and reviewed annually to maintain compliance.


[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 Class A classification justification and implications for AirSentry Urban Air Quality Station, a Class A Air Quality Monitoring Station Firmware. Reference IEC 62304 Clause 4.3.
IoT firmware for urban air quality monitoring stations measuring PM2.5, NO2, O3, and CO. Publishes data to public API.

[Assistant] Content: The AirSentry Urban Air Quality Station Air Quality Monitoring Station Firmware receives a Class A safety classification because its failure modes result exclusively in loss of non-critical functionality. The software performs Continuous measurement and public reporting of urban air quality parameters without affecting clinical decisions, therapeutic delivery, or patient monitoring that requires fail-safe behavior. This classification means detailed design (Clause 5.4), unit verification (Clause 5.5), and integration testing (Clause 5.6) are not required.


[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):

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

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


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

[User]
Expand requirement SRS-DATA-001: "data retention period" (Category: data)
Project: GaitSense Walking Analysis | Gait Analysis Insole Firmware | Class B
Quantitative gait analysis using instrumented insoles for orthopedic and rehabilitation assessment. Instrumented insole firmware analyzing gait patterns and detecting asymmetries. Reports generated for orthopedic assessment.

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 GaitSense Walking Analysis shall retain measurement data in non-volatile storage for the specified minimum retention period, after which data may be overwritten.
Rationale: Data retention supports clinical trend analysis and regulatory requirements for record keeping associated with the Gait Analysis Insole Firmware.
Priority: Mandatory
Acceptance Criterion: Oldest data record remains retrievable after continuous operation for the specified retention period.
Source: Regulatory


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

[User]
Expand requirement SRS-PERF-001: "resource utilization limits" (Category: performance)
Project: AnticoagCalc INR Dose Adjuster | Anticoagulation Dosing Support Tool | Class B
Suggesting warfarin dose adjustments based on INR values for physician review. Web tool suggesting warfarin dose adjustments based on INR readings and patient history. Clinical decision support requiring physician review.

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

[Assistant]
Description: The AnticoagCalc INR Dose Adjuster memory footprint on Web application shall remain within specified limits under worst-case operational scenarios.
Rationale: Memory constraints are fixed by the Web application hardware and must be respected to prevent resource exhaustion during operation.
Priority: Mandatory
Acceptance Criterion: Memory profiling under stress conditions shows stable allocation with no leaks over a 72-hour test period.
Source: System requirement


[System] You are 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 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: Interaction requirements for the GlucoSpot Continuous Glucose Display specify all user-facing behaviors of the CGM Display 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 RetinaScan Pro (diabetic retinopathy screening AI, Class B):

"The RetinaScan Pro software architecture defines three software items with documented interfaces per Clause 5.3.2. Data formats, protocols, and error handling are specified for each interface. SOUP components are identified per Clause 5.3.3."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the RetinaScan Pro (diabetic retinopathy screening AI, Class B). Standards references are accurate.


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

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

"The testing strategy includes unit testing of all modules, integration testing of interfaces, and system testing."

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


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

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


[System] You are a 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):

"Maintenance activities follow IEC 62304:2020 Clause 6."

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


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

[User]
Write a FMEA section on documenting failure modes and their effects for MindCalm Meditation Timer, a Class A Meditation Wellness App. Reference IEC 62304 Clauses 7.1.2, 7.1.4.
Mobile app providing guided meditation timers with optional heart rate display during sessions. Heart rate shown for interest only, not diagnostic.

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


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

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

[Assistant] Content: Requirements for external system integration with the MindCalm Meditation Timer specify the API contracts, data formats, and error handling behavior for all outbound communication from the Meditation Wellness App. 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 sensor and communication protocol requirements for ECGInsight Rhythm Interpreter, a Class B ECG Interpretation Service. Reference IEC 62304 Clause 5.2.2.
Cloud service analyzing 12-lead ECG recordings and generating preliminary rhythm interpretations for physician review.

[Assistant] Content: The ECGInsight Rhythm Interpreter communication interfaces include DICOM ECG input, HL7 results output connecting the ECG Interpretation Service to external systems and sensors. Each interface requirement specifies the expected behavior under normal operation and the response to communication failure conditions.


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

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

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

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


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

[User]
Write a SDP section on lightweight review process for Class A for DoseLog Radiation Badge Reader, a Class A Dosimetry Data Logger. Reference IEC 62304 Clause 5.1.1.
Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

[Assistant] Content: Review of DoseLog Radiation Badge Reader Class A deliverables consists of a peer review by the project lead and a quality check by the QA representative. The review confirms completeness of the SDP, traceability of requirements, and adequacy of the system test plan. Independent technical review is not required for the Dosimetry Data Logger at this classification level.


[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 GlucoEdge Continuous Glucose Platform, a Class B Hybrid CGM Edge-Cloud Platform. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Hybrid system: embedded BLE firmware on a wearable CGM patch streams readings to a phone app, which uploads to cloud for trend analysis and physician dashboard.

[Assistant] Content: The failure mode identification for the GlucoEdge Continuous Glucose Platform Hybrid CGM Edge-Cloud Platform per Clause 7.1.2 considers every processing step from input to output. Failure categories include data corruption, computation error, timing fault, and communication loss. Each failure mode is linked to its potential causes, including SOUP defects evaluated per Clause 7.1.3.


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

[User]
Expand requirement SRS-PERF-003: "computational accuracy requirement" (Category: performance)
Project: NutriCalc TPN Formulation Tool | TPN Formulation Calculator | Class B
Calculating TPN component concentrations and volumes based on nutritional requirements. Desktop tool calculating total parenteral nutrition formulations based on patient metabolic needs and lab values.

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

[Assistant]
Description: The NutriCalc TPN Formulation Tool shall maintain measurement accuracy within the specified tolerance across the full operating range of the primary sensor.
Rationale: Measurement accuracy directly affects clinical decisions based on the TPN Formulation Calculator output and is a key factor in the risk profile.
Priority: Mandatory
Acceptance Criterion: Accuracy verified against a calibrated reference across the full measurement range, with all readings within tolerance for 200+ test points.
Source: Regulatory


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

[User]
Expand requirement SRS-PERF-003: "end-to-end processing latency" (Category: performance)
Project: OBDView Diagnostic Display | Vehicle Diagnostic Display App | Class A
Displaying vehicle diagnostic information from OBD-II interface for driver and mechanic use. Mobile app connecting to vehicle OBD-II port to display engine parameters, fault codes, and emissions 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: End-to-end latency from primary sensor data acquisition to output presentation shall not exceed the specified limit under normal operating conditions.
Rationale: Bounded processing latency ensures the Vehicle Diagnostic Display App provides readings reflecting the current state without clinically significant delay.
Priority: Mandatory
Acceptance Criterion: End-to-end latency is within the specified limit for 99.9% of samples over a 24-hour test period.
Source: System requirement


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

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

"Compliance with IEC 62304 Clause 10.1 is demonstrated through continuous monitoring."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 10.1 which does not exist. IEC 62304 has no Clause 10. Standard ends at Clause 9. 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-INTF-001: "clinical system integration interface" (Category: interface)
Project: GrowthChart Pediatric Viewer | Growth Chart Display App | Class A
Visual display of pediatric growth measurements on standard percentile charts. Web app displaying pediatric growth charts with WHO/CDC percentile curves. Plots measurements, no diagnostic interpretation.

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 GrowthChart Pediatric Viewer shall exchange data with external systems via FHIR Observation API using the specified message format with error handling.
Rationale: External system connectivity is required for the Growth Chart Display App to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Format validation passes for all message types with correct field encoding verified.
Source: User need


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

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

[Assistant] Content: Persistent data managed by the NutriView Food Diary includes configuration parameters, acquired measurements from data sources, and operational logs. Data integrity requirements specify error detection mechanisms and the Nutritional Tracking Display App response to data corruption events.


[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 development plan references IEC 62304 Clause 5.1.12 and Clause Annex A.1 for the HeartLink."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clauses 5.1.12 and Annex A.1, neither of which exists. Clause 5.1 has 5.1.1 through 5.1.11 only. IEC 62304 annexes are informative, not cited as requirements. All clause references must be corrected.


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

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

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

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


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

[User]
Write a SAD section on data paths and processing pipeline for NeoVent Neonatal Ventilator, a Class C Neonatal Ventilator Firmware. Reference IEC 62304 Clauses 5.3.1, 5.3.2.
Neonatal ventilator firmware supporting CPAP, NIPPV, and conventional ventilation for extremely premature infants. Tidal volumes as low as 2 mL.

[Assistant] Content: The processing pipeline of the NeoVent Neonatal Ventilator consists of sequential data transformations from raw input through processed output. Interface contracts per Clause 5.3.2 define the data format, timing, and error conditions at each pipeline stage boundary. The Neonatal Ventilator Firmware architecture supports both streaming and batch processing modes where required.


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

[User]
Write a SDP section on Class A classification justification and implications for AquaGuard Water Quality Monitor, a Class A Water Quality Monitoring Firmware. Reference IEC 62304 Clause 4.3.
Firmware for a multi-parameter water quality probe measuring pH, dissolved oxygen, conductivity, and turbidity in rivers and lakes.

[Assistant] Content: The AquaGuard Water Quality Monitor Water Quality Monitoring Firmware receives a Class A safety classification because its failure modes result exclusively in loss of non-critical functionality. The software performs In-situ measurement of water quality parameters for environmental monitoring without affecting clinical decisions, therapeutic delivery, or patient monitoring that requires fail-safe behavior. This classification means detailed design (Clause 5.4), unit verification (Clause 5.5), and integration testing (Clause 5.6) are not required.


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

[User]
Expand requirement SRS-SEC-002: "authentication for configuration access" (Category: security)
Project: WoundTrack Healing Analyzer | Wound Assessment App | Class B
Photographic wound measurement and healing progress tracking for clinical review. Mobile app photographing wounds and measuring area/perimeter over time to track healing progress for clinician 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: Access to configuration and administrative functions of the Wound Assessment App shall be restricted to authenticated and authorized users.
Rationale: Unauthorized configuration changes to the Wound Assessment App could compromise its intended function or patient safety.
Priority: Mandatory
Acceptance Criterion: Brute-force protection activates after the specified number of failed authentication attempts.
Source: Risk control


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

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

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

[User]
Write a SDP section on test records and acceptance criteria for Class B for VitalPulse SpO2 Monitor, a Class B Pulse Oximeter Firmware. Reference IEC 62304 Clauses 5.6.7, 5.7.5.
Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

[Assistant] Content: The VitalPulse SpO2 Monitor verification records comprise integration test results (Clause 5.6.7) and system test results (Clause 5.7.5). Pass criteria require every architectural interface exercised by at least one integration test and every SRS requirement covered by at least one system test. Anomalies are tracked in the problem resolution process per Clause 9.1.


[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):

"Standards compliance for the WoundTrack wound measurement imaging system 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 requirements engineer for IEC 62304 medical device software. Expand requirements into structured fields with specific, measurable descriptions. Priority must be Mandatory, Desirable, or Optional. Acceptance criteria must be testable. Do not fabricate standard references. IEC 62304 is a single-part standard with no sub-parts.

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

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

[Assistant]
Description: The CardioRhythm ECG Analyzer shall encrypt patient-identifiable data at rest, ensuring that raw storage access cannot reveal protected health information.
Rationale: Encryption of stored patient data protects against unauthorized disclosure if the Single-Lead ECG Device Firmware storage media is accessed outside the intended context.
Priority: Mandatory
Acceptance Criterion: Encrypted storage verified by reading raw storage media and confirming no patient-identifiable data is visible without the decryption key.
Source: Regulatory


[System] You are 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):

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

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


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

[User]
Write a SDP section on requirements verification approach for RenalDose Renal Adjustment Calculator, a Class B Renal Dose Adjustment Calculator. Reference IEC 62304 Clause 5.2.6.
Calculator adjusting medication doses for patients with impaired renal function based on eGFR.

[Assistant] Content: Requirements verification for the RenalDose Renal Adjustment Calculator is conducted per Clause 5.2.6 before the requirements baseline is established. The review confirms completeness, consistency, and testability. Any requirement failing these criteria is returned for rework before the Renal Dose Adjustment Calculator proceeds to design.


[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 SterilLog Sterilization Record System, a Class A Sterilization Record Logger. Reference IEC 62304 Clauses 7.1.2, 7.2.1.
Software logging sterilization cycle parameters from autoclaves. Records temperature, pressure, and time for compliance documentation.

[Assistant] Content: Hazard identification for the SterilLog Sterilization Record System per Clause 7.1.2 considers all software functions that could contribute to patient harm. Identified causes include incorrect serial port data from autoclave processing, loss of communication on RS-232, and failure to detect out-of-range conditions during Recording and archiving sterilization cycle parameters for regulatory compliance.


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

[User]
Expand requirement SRS-FUNC-003: "data logging and retrieval" (Category: functional)
Project: CalibrationTracker Equipment Logger | Calibration Record System | Class A
Tracking calibration schedules and recording calibration results for compliance. Web application tracking calibration dates and results for medical test equipment. Administrative record keeping.

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

[Assistant]
Description: All processed measurements shall be stored with timestamps in a persistent log accessible through REST API for clinical review and regulatory audit.
Rationale: Data logging supports clinical review, trend analysis, and regulatory audit trail requirements for the Calibration Record System.
Priority: Desirable
Acceptance Criterion: Data retrieval produces complete, uncorrupted records for the full specified retention period.
Source: User need