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

[User]
Expand requirement SRS-FUNC-004: "display update rate for Appointment Scheduling System" (Category: functional)
Project: ScheduleSync Appointment Manager | Appointment Scheduling System | Class A
Administrative scheduling and calendar management for clinical appointments. Web application for scheduling patient appointments across multiple clinics. Administrative scheduling only, no clinical workflow.

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

[Assistant]
Description: The ScheduleSync Appointment Manager display shall present current readings on REST API within the specified maximum update latency.
Rationale: Display freshness is critical for the Appointment Scheduling System to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: End-to-end latency from data acquisition to display update does not exceed the specified limit for 99.9% of samples.
Source: User need


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

[User]
Write a SDP section on SOUP identification and management for TriageAI Emergency Triage Assistant, a Class B ED Triage Decision Support App. Reference IEC 62304 Clause 8.1.2.
Tablet app assisting nurses in emergency department triage scoring based on vital signs and presenting symptoms.

[Assistant] Content: The TriageAI Emergency Triage Assistant SOUP register identifies every third-party component deployed in the ED Triage Decision Support App, including version, source, and functional role. Updates to SOUP items trigger re-evaluation of known anomalies per Clause 7.1.3 and regression testing proportional to the scope of change.


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

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

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

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


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

[User]
Write a SRS section on external system communication requirements for ClinTrial EDC Platform, a Class A Clinical Trial EDC Web Platform. Reference IEC 62304 Clause 5.2.2.
Enterprise web platform for electronic data capture in multi-site clinical trials. Manages case report forms, randomization, and adverse event reporting.

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


[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 CardioPulse Monitor (cardiac rhythm monitor, Class B):

"Software release for the CardioPulse Monitor follows Clause 5.8. Completeness is ensured per Clause 5.8.1, version identification per Clause 5.8.2, and known residual anomalies are documented per Clause 5.8.4 and evaluated per Clause 5.8.5."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the CardioPulse Monitor (cardiac rhythm monitor, Class B). Standards references are accurate.


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

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

"The HydroLog problem resolution process follows Clause 9. Problem reports are prepared per Clause 9.1, investigated per Clause 9.2, and resolved through the change control process per Clause 9.4. Trends are analyzed per Clause 9.6."

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

[User]
Write a SDP section on risk control requirements traceability for SupplyChain Procurement Portal, a Class A Supply Chain Procurement System. Reference IEC 62304 Clause 5.2.3.
Web portal for ordering medical supplies with approval workflows. Procurement and logistics only.

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


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

[User]
Write a SDP section on primary international standards applicable to development for ConsentView Informed Consent Archive, a Class A Consent Document Viewer. Reference IEC 62304 Clause 5.1.2.
Web portal for patients and staff to view signed informed consent documents. Read-only document viewer.

[Assistant] Content: The ConsentView Informed Consent Archive development lifecycle is governed by IEC 62304:2006+AMD1:2015. Risk management follows ISO 14971:2019. The quality management system underpinning all activities conforms to ISO 13485:2016. Usability engineering for the Consent Document Viewer interface adheres to IEC 62366-1:2015+AMD1:2020.


[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):

"REQ-SRS-078: The SleepWell 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 SleepWell (sleep quality display app, Class A):

"The software shall be developed in accordance with best practices and applicable standards. Development activities will be performed as appropriate for the project scope."

[Assistant]
Verdict: FAIL
Note: The documentation section contains generic filler. Phrases like "as appropriate", "best practices", "applicable standards" provide no project-specific information about the SleepWell sleep quality display app. Content must reference specific IEC 62304 clauses, concrete activities, and measurable criteria.


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

[User]
Expand requirement SRS-SEC-001: "cryptographic data security" (Category: security)
Project: HomeVent BiPAP Controller | BiPAP Device Firmware | Class C
Home bilevel ventilatory support with auto-titrating pressure and leak compensation. Home bilevel positive airway pressure device firmware. Manages inspiratory/expiratory pressure, leak compensation, and patient triggering.

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 HomeVent BiPAP Controller shall encrypt patient-identifiable data at rest, ensuring that raw storage access cannot reveal protected health information.
Rationale: Encryption of stored patient data protects against unauthorized disclosure if the BiPAP 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 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 MedRef Clinical Reference App, a Class A Clinical Drug Reference App. Reference IEC 62304 Clause 5.2.2.
Standalone mobile app providing searchable drug reference database with interaction checker. Display-only — no prescription or dosing decisions.

[Assistant] Content: Interface requirements for the MedRef Clinical Reference App specify the communication protocols, data formats, and timing constraints for each external interface of the Clinical Drug Reference App. The primary data acquisition interface uses REST API for DB sync with specified data rates and error detection mechanisms.


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

[User]
Write a SDP section on risk control verification and traceability for GasMonitor Anesthetic Gas Logger, a Class A Anesthetic Gas Concentration Logger. Reference IEC 62304 Clauses 7.3.1, 7.3.2.
Software logging waste anesthetic gas concentrations in operating rooms for occupational safety compliance. Recording only.

[Assistant] Content: Verification of risk controls for the GasMonitor Anesthetic Gas Logger follows Clause 7.3.1. Each control implemented in software has a corresponding test case that demonstrates the hazardous condition is mitigated. Traceability records per Clause 7.3.2 document the chain from hazard through requirement to verification evidence.


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

[User]
Write a TRACE section on purpose and scope of the traceability matrix for DoseLog Radiation Badge Reader, a Class A Dosimetry Data Logger. Reference IEC 62304 Clause 5.7.1.
Desktop software reading and archiving personal radiation dosimeter data. Records exposure history for occupational health compliance.

[Assistant] Content: Traceability for the DoseLog Radiation Badge Reader per Clause 5.7.1 links system requirements to software requirements, software requirements to design elements, and design elements to verification test cases. The matrix serves as the primary evidence that the Dosimetry Data Logger verification is complete and that no requirement is unaddressed.


[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 HydroRemind Hydration Tracker, a Class A Hydration Tracking Firmware. Reference IEC 62304 Clauses 7.1.2, 7.1.3.
Smart water bottle firmware tracking daily water intake via a flow sensor. Displays consumption on an e-ink screen. No health recommendations.

[Assistant] Content: Software failure modes in the HydroRemind Hydration Tracker are identified using a structured approach per Clause 7.1.2: each software item is analyzed for what could go wrong (the failure mode), why it could go wrong (the cause), and what would happen (the effect). SOUP component anomalies per Clause 7.1.3 are included as potential failure causes.


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

[User]
Expand requirement SRS-FUNC-002: "alarm threshold management" (Category: functional)
Project: DialyFlow Dialysis Fluid Controller | Hemodialysis Fluid Controller Firmware | Class C
Controlling dialysate composition, flow rates, and ultrafiltration in hemodialysis. Firmware controlling dialysate flow rates and composition in a hemodialysis machine. Fluid balance errors could be fatal.

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

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

[User]
Write a SAD section on interface design between software items for VitalPulse SpO2 Monitor, a Class B Pulse Oximeter Firmware. Reference IEC 62304 Clause 5.3.2.
Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

[Assistant] Content: Internal interface design for the VitalPulse SpO2 Monitor follows Clause 5.3.2. Each interface is documented with its function signature, parameter constraints, return value semantics, and thread safety guarantees. The Pulse Oximeter Firmware interfaces are designed for testability, supporting both integration testing and fault injection.


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

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

"Software development follows IEC 62304 Clause 10.1 requirements for detailed design verification."

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

[User]
Write a SAD section on SOUP component integration and requirements for ScreenFlow Population Health Screener, a Class A Serverless Population Health Screening SaMD. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Serverless cloud application processing population-level health screening questionnaires and flagging individuals for follow-up based on risk scoring algorithms.

[Assistant] Content: Third-party software components used in the ScreenFlow Population Health Screener are documented per Clause 5.3.3, including functional and performance requirements imposed on each SOUP item. Hardware and software dependencies per Clause 5.3.4 are recorded to ensure that the AWS Lambda + DynamoDB + API Gateway environment satisfies all SOUP prerequisites.


[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 threat model data flow decomposition for DialyFlow Dialysis Fluid Controller, a Class C Hemodialysis Fluid Controller Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware controlling dialysate flow rates and composition in a hemodialysis machine. Fluid balance errors could be fatal.

[Assistant] Content: The DialyFlow Dialysis Fluid Controller data flow diagrams for threat analysis map all data movement within and across the Hemodialysis Fluid Controller Firmware boundary. Trust boundaries are placed at external interfaces (CAN bus, safety relay outputs), persistent storage, and inter-process communication points.


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

[User]
Write a SDP section on primary international standards applicable to development for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clause 5.1.2.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: Development of the CochleaMap CI Fitting Software software conforms to IEC 62304:2006+AMD1:2015 for the software lifecycle and ISO 14971:2019 for risk management integration. Quality management activities follow ISO 13485:2016, while usability engineering principles from IEC 62366-1:2015+AMD1:2020 inform the user interface design of the Cochlear Implant Fitting Software.


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

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

"Software release for the NeuroStim Programmer follows Clause 5.8. Completeness is ensured per Clause 5.8.1, version identification per Clause 5.8.2, and known residual anomalies are documented per Clause 5.8.4 and evaluated per Clause 5.8.5."

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


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

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

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

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


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

[User]
Write a SRS section on safety requirements for Class A -- confirms no safety functions for AuditTrail QMS Event Logger, a Class A QMS Audit Trail Service. Reference IEC 62304 Clauses 5.2.2, 5.2.3.
Microservice capturing and storing quality management system audit events. Logging and reporting only.

[Assistant] Content: As a Class A system, the AuditTrail QMS Event Logger does not implement software safety functions. The QMS Audit Trail Service presents acquired data for informational purposes only. No risk control measure per Clause 5.2.3 is implemented in software -- all identified risks are addressed by the informational-only design.


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

[User]
Write a SDP section on change control and trend analysis for problems for RetinaScan Diabetic Retinopathy Screener, a Class B Retinal Screening Software. Reference IEC 62304 Clauses 9.4, 9.6.
Desktop software analyzing retinal fundus images to detect signs of diabetic retinopathy for ophthalmologist review.

[Assistant] Content: The RetinaScan Diabetic Retinopathy Screener problem correction workflow routes all fixes through the change control process per Clause 9.4. Trend analysis per Clause 9.6 reviews accumulated problem reports at each phase gate to detect recurring defect patterns, common root causes, and areas of the Retinal Screening Software requiring additional verification attention.


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

[Assistant] Content: Data requirements for the ChemoFlow Infusion Controller specify retention periods, storage formats, and integrity controls for all persistent data managed by the Chemotherapy Infusion Pump Firmware. Data integrity is ensured through checksums or cryptographic hashes, and corrupted data is detected before use in any processing function.


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

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

[Assistant] Content: Functional requirements for the CalibrationTracker Equipment Logger are derived from the system requirements for Tracking calibration schedules and recording calibration results for compliance and from risk control measures identified in the ISO 14971 analysis. Each requirement specifies a single function of the Calibration Record System with measurable acceptance criteria.


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

[User]
Write a SRS section on functional requirements overview for LinacControl Beam Delivery System, a Class C Linear Accelerator Control Software. Reference IEC 62304 Clause 5.2.2.
Software controlling linear accelerator beam delivery during radiation therapy. Beam-on errors could deliver lethal radiation doses.

[Assistant] Content: The LinacControl Beam Delivery System functional requirements define what the Linear Accelerator Control Software does in response to user inputs, sensor data, and system events. Requirements are organized by functional area: data acquisition, signal processing, display and output, and system management. Each requirement is individually testable.


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

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

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

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


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

[User]
Expand requirement SRS-PERF-001: "data processing timing constraint" (Category: performance)
Project: WeatherNode Microclimate Station | Weather Station Firmware | Class A
Automated measurement and transmission of microclimate weather parameters. Solar-powered weather station firmware measuring temperature, humidity, wind, rainfall, and barometric pressure.

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

[Assistant]
Description: Processing latency of the Weather Station Firmware shall be bounded to ensure timely output that reflects current input conditions.
Rationale: Bounded processing latency ensures the Weather Station Firmware provides readings reflecting the current state without clinically significant delay.
Priority: Mandatory
Acceptance Criterion: End-to-end latency is within the specified limit for 99.9% of samples over a 24-hour test period.
Source: System requirement


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

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

"SOUP management for the ChemoCalc includes identification (Clause 8.1.2), functional specification (Clause 5.3.3), and anomaly list evaluation (Clause 7.1.3). SOUP items are version-controlled and changes are managed through the change control process (Clause 8.2)."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the ChemoCalc (chemotherapy dose calculator, Class C). 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-002: "primary sensor interface protocol" (Category: interface)
Project: BeamPlan Radiation Treatment Planner | Radiation Treatment Planning Software | Class C
Calculating optimal radiation beam configurations and dose distributions for cancer treatment. Desktop software calculating radiation treatment plans including beam angles, dose distribution, and organ-at-risk constraints.

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 Radiation Treatment Planning Software sensor interface shall establish and maintain reliable communication with the primary sensor via DICOM RT import/export.
Rationale: Sensor link integrity directly impacts data quality and the reliability of the Radiation Treatment Planning 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 tools and tool qualification for Class A for AllergyCard Patient Allergy Viewer, a Class A Patient Allergy Display. Reference IEC 62304 Clause 5.1.4.
Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

[Assistant] Content: Development of the AllergyCard Patient Allergy Viewer uses TypeScript/Vue on Web kiosk (Chrome kiosk mode). Build automation ensures reproducible compilation, and all toolchain versions are recorded as part of the configuration management baseline. Given the Class A classification, no formal tool qualification report is produced; tool defects are handled through the standard problem resolution process.


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

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

[Assistant] Content: The AquaGuard Water Quality Monitor data requirements define how the Water Quality Monitoring Firmware stores, retrieves, and protects data acquired during In-situ measurement of water quality parameters for environmental monitoring. Requirements specify data format, retention duration, backup frequency, and the behavior when data corruption is detected.


[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 primary international standards applicable to development for GrowthChart Pediatric Viewer, a Class A Growth Chart Display App. Reference IEC 62304 Clause 5.1.2.
Web app displaying pediatric growth charts with WHO/CDC percentile curves. Plots measurements, no diagnostic interpretation.

[Assistant] Content: The GrowthChart Pediatric Viewer development lifecycle is governed by IEC 62304:2006+AMD1:2015. Risk management follows ISO 14971:2019. The quality management system underpinning all activities conforms to ISO 13485:2016. Usability engineering for the Growth Chart Display App interface adheres to IEC 62366-1:2015+AMD1:2020.


[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: "memory usage budget" (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 memory footprint on Windows desktop shall remain within specified limits under worst-case operational scenarios.
Rationale: Exceeding memory limits could cause undefined behavior in the TPN Formulation Calculator, potentially affecting safety.
Priority: Mandatory
Acceptance Criterion: Peak RAM usage during worst-case scenario does not exceed the specified limit, with minimum margin remaining.
Source: System requirement


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

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

"An independent safety reviewer shall verify all risk control measures implemented in the NurseCall Hub software before each release."

[Assistant]
Verdict: FAIL
Note: Content mandates independent safety review for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Independent verification is a Class C requirement, 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 ArthroNav (surgical navigation system, Class C):

"IEC 62304 Clause 5.5.2.1 requires the ArthroNav to implement data archival."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 5.5.2.1 which does not exist. IEC 62304 has no four-level numbering. The reference must be corrected to a valid clause number.


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

[User]
Expand requirement SRS-DATA-002: "data retention period" (Category: data)
Project: NeuroTune DBS Programmer | Deep Brain Stimulator Programmer App | Class C
Programming stimulation parameters of implanted deep brain stimulators for Parkinson's disease management. Tablet application programming deep brain stimulation implants for movement disorders. Stimulation parameter errors could cause neurological harm.

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

[Assistant]
Description: Measurement records stored by the Deep Brain Stimulator Programmer App shall be maintained for the configured retention period before eligible for overwrite.
Rationale: Data retention supports clinical trend analysis and regulatory requirements for record keeping associated with the Deep Brain Stimulator Programmer App.
Priority: Mandatory
Acceptance Criterion: Oldest data record remains retrievable after continuous operation for the specified retention period.
Source: Regulatory


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

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

[Assistant] Content: External interface requirements for the RoomBoard Digital Signage Patient Room Digital Signage define the data exchanged across each interface boundary: MQTT, REST API. For each interface, requirements specify the protocol, data format, timing, and error recovery behavior.


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

[User]
Write a SRS section on data format and interoperability requirements for SeismicWatch Earthquake Early Warning, a Class A Seismic Early Warning Firmware. Reference IEC 62304 Clause 5.2.2.
Firmware for a network of MEMS accelerometers providing earthquake early warning by detecting P-waves and estimating magnitude.

[Assistant] Content: Data exchanged by the SeismicWatch Earthquake Early Warning via Ethernet conforms to defined formats documented in this SRS. The Seismic Early Warning Firmware validates incoming data against the format specification and rejects malformed messages with a logged error. Output data formats are deterministic and reproducible.


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

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

"Software safety classification is performed per IEC 62304-5 Clause 4.3."

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


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

[User]
Write a SAD section on SOUP component integration and requirements for SeismicWatch Earthquake Early Warning, a Class A Seismic Early Warning Firmware. Reference IEC 62304 Clauses 5.3.3, 5.3.4.
Firmware for a network of MEMS accelerometers providing earthquake early warning by detecting P-waves and estimating magnitude.

[Assistant] Content: Third-party software components used in the SeismicWatch Earthquake Early Warning are documented per Clause 5.3.3, including functional and performance requirements imposed on each SOUP item. Hardware and software dependencies per Clause 5.3.4 are recorded to ensure that the Zynq-7000 SoC (FPGA + ARM) environment satisfies all SOUP prerequisites.


[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: "power-on self-test sequence" (Category: functional)
Project: GlucoSpot Continuous Glucose Display | CGM Display App | Class B
Displaying continuous glucose monitor readings with trend analysis and glucose range alerts. Mobile app receiving and displaying continuous glucose monitor readings via BLE. Shows trends, time-in-range, and configurable glucose alerts.

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

[Assistant]
Description: The GlucoSpot Continuous Glucose Display 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 CGM Display App 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 an IEC 62304 regulatory documentation expert. Generate precise, class-appropriate content for medical device software documentation.

[User]
Write a SDP section on risk control requirements traceability for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clause 5.2.3.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

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


[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 BeamPlan Radiation Treatment Planner, a Class C Radiation Treatment Planning Software. Reference IEC 62304 Clauses 7.2.1, 7.2.2.
Desktop software calculating radiation treatment plans including beam angles, dose distribution, and organ-at-risk constraints.

[Assistant] Content: Risk control measures for the BeamPlan Radiation Treatment Planner Radiation Treatment Planning Software are prioritized per Clause 7.2.1: inherently safe design first, then protective measures in software, then information for safety. Software-implemented controls per Clause 7.2.2 are expressed as verifiable requirements and traced to their originating hazard.


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

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

"The EchoAssist addresses IEC 62304 Clause Annex A.1 (security testing) through formal review."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause Annex A.1 which does not exist. IEC 62304 annexes are informative, not cited as requirements. The reference must be corrected to a valid clause number.


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

[User]
Write a SRS section on functional requirements overview for PowerTrack UPS Monitor, a Class A UPS Monitoring Software. Reference IEC 62304 Clause 5.2.2.
Software monitoring uninterruptible power supply status for critical medical equipment rooms. Logs voltage, load, and battery health.

[Assistant] Content: Functional requirements for the PowerTrack UPS Monitor specify the data processing, user interaction, and output generation capabilities of the UPS Monitoring Software. Each requirement describes a discrete function the software shall perform during Logging and displaying UPS status for facility infrastructure monitoring, with acceptance criteria sufficient to derive verification test cases.


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

[User]
Write a SRS section on functional requirements overview for PharmLog Medication History Viewer, a Class A Medication History Viewer. Reference IEC 62304 Clause 5.2.2.
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 functional requirements define what the Medication History Viewer does in response to user inputs, sensor data, and system events. Requirements are organized by functional area: data acquisition, signal processing, display and output, and system management. Each requirement is individually testable.


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

[User]
Expand requirement SRS-SAFE-001: "fault response and safe shutdown" (Category: safety)
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 Single-Lead ECG Device Firmware shall enter a defined safe state within the maximum allowable transition time when a critical fault is detected, ensuring no hazardous output persists.
Rationale: A deterministic safe-state transition prevents the Single-Lead ECG Device Firmware from operating in an unknown or hazardous state after a detected fault.
Priority: Mandatory
Acceptance Criterion: All 20 defined fault scenarios result in correct safe-state entry within timing limits across 10 iterations each.
Source: Risk control


[System] You are a regulatory 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):

"Risk control measures are implemented per IEC 62311-1 Clause 7."

[Assistant]
Verdict: FAIL
Note: The documentation references "IEC 62311-1" which is incorrect. IEC 62311 covers EMF exposure limits, not medical device software. 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 system test execution and acceptance for Class A for SterilLog Sterilization Record System, a Class A Sterilization Record Logger. Reference IEC 62304 Clauses 5.7, 5.7.4.
Software logging sterilization cycle parameters from autoclaves. Records temperature, pressure, and time for compliance documentation.

[Assistant] Content: The SterilLog Sterilization Record System system test suite runs on Windows desktop exercising all functional, performance, and interface requirements. Clause 5.7.4 verification confirms every SRS requirement has at least one passing system test. Unit-level verification (Clause 5.5) and integration testing (Clause 5.6) are outside the scope of Class A verification and are not executed.


[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 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: Security requirements for the CardioRhythm ECG Analyzer address authentication, data protection, and access control for the Single-Lead ECG Device Firmware. All persistent data is encrypted at rest, and data in transit over USB uses transport layer encryption. Security requirements are aligned with IEC 81001-5-1:2021.


[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: "stored data corruption detection" (Category: data)
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 detect corrupted measurement records through integrity checking and flag affected entries for review.
Rationale: Data integrity mechanisms ensure measurement records retrieved from the TPN Formulation Calculator are trustworthy for clinical review.
Priority: Mandatory
Acceptance Criterion: Integrity check correctly identifies all corrupted records with zero false positives on uncorrupted data.
Source: System requirement


[System] You are a regulatory 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 PharmLog Medication History Viewer, a Class A Medication History Viewer. Reference IEC 62304 Clauses 5.7, 5.7.1.
Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

[Assistant] Content: As Class A software, the PharmLog Medication History Viewer requires only system-level verification per IEC 62304 Clause 5.7. The test suite covers all requirements in the SRS, with tests executed against the Medication History Viewer under representative operating conditions on iOS. Unit and integration testing are not performed, as the Class A classification does not require verification below the system level.


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

[User]
Write a SRS section on resource constraints and scalability for AssetTrack Equipment Inventory, a Class A Equipment Inventory System. Reference IEC 62304 Clause 5.2.2.
Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management only.

[Assistant] Content: Resource requirements for the AssetTrack Equipment Inventory specify maximum memory utilization, persistent storage consumption, and processor loading on Android. The Equipment Inventory System must operate within these constraints under worst-case conditions without degradation of safety-relevant functions.


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

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

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

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


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

[User]
Review this documentation excerpt for the DermaScan AI (skin lesion classifier, Class B):

"The DermaScan AI is designed to meet all applicable performance criteria. System requirements are addressed through appropriate design activities."

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


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

[User] Does IEC 62304-6 exist?

[Assistant] No. IEC 62304 has no Part 6 or any sub-parts. It is a single-part standard.


[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: "configuration persistence and validation" (Category: functional)
Project: NeoVent Neonatal Ventilator | Neonatal Ventilator Firmware | Class C
Mechanical ventilatory support for neonatal patients with precise low-volume delivery. Neonatal ventilator firmware supporting CPAP, NIPPV, and conventional ventilation for extremely premature infants. Tidal volumes as low as 2 mL.

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: Configuration changes to the NeoVent Neonatal Ventilator shall be validated against allowed ranges before acceptance and persisted to survive power loss.
Rationale: Configurable parameters allow the Neonatal Ventilator Firmware to be adapted to different clinical protocols and patient populations.
Priority: Mandatory
Acceptance Criterion: All configurable parameters persist correctly across power cycles and reject out-of-range values with appropriate error messages.
Source: User need


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

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

"All LabView Portal software units shall undergo formal verification by an independent test team using white-box and black-box techniques."

[Assistant]
Verdict: FAIL
Note: Content mandates formal unit verification by independent test team for Class A. IEC 62304 Class A requires only system-level verification (Clause 5.7). Unit verification (Clause 5.5) and independent testing are not required for Class A.


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

[User]
Expand requirement SRS-INTF-001: "external system data exchange" (Category: interface)
Project: DreamLog Sleep Monitor | Sleep Tracking Display App | Class A
Visualizing sleep quality data for personal wellness awareness. Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

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

[Assistant]
Description: Data interoperability with clinical information systems shall be provided through BLE 5.2, supporting standard message formats.
Rationale: External system connectivity is required for the Sleep Tracking Display App to function within the broader clinical infrastructure.
Priority: Desirable
Acceptance Criterion: Successful bidirectional data exchange confirmed with 1000 test messages and zero message loss.
Source: User need


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

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

"Software development follows IEC 62304 Clause 11.1 requirements for operational qualification."

[Assistant]
Verdict: FAIL
Note: The documentation cites IEC 62304 Clause 11.1 which does not exist. IEC 62304 has no Clause 11. The reference must be corrected to a valid clause number.


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

[User]
Expand requirement SRS-SEC-002: "authentication for configuration access" (Category: security)
Project: CardioCloud ECG Analysis Service | Cloud ECG Analysis SaMD | Class B
Automated arrhythmia detection and ECG interpretation as a cloud service for remote clinics. Cloud SaaS platform receiving 12-lead ECG recordings from clinics, running automated arrhythmia detection, and returning annotated results via FHIR API.

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 CardioCloud ECG Analysis Service shall require authentication before allowing modification of device configuration parameters via REST API.
Rationale: Access control prevents unauthorized modification of the Cloud ECG Analysis SaMD operating parameters.
Priority: Mandatory
Acceptance Criterion: Brute-force protection activates after the specified number of failed authentication attempts.
Source: Risk control


[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-001: "user identity verification" (Category: security)
Project: TriagePro Emergency Scoring App | Emergency Department Triage SaMD | Class B
Guiding emergency department triage scoring using the Manchester Triage System protocol. Standalone tablet app implementing Manchester Triage System scoring. Guides clinicians through triage flowchart and records patient acuity level.

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

[Assistant]
Description: Access to configuration and administrative functions of the Emergency Department Triage SaMD shall be restricted to authenticated and authorized users.
Rationale: Unauthorized configuration changes to the Emergency Department Triage SaMD could compromise its intended function or patient safety.
Priority: Mandatory
Acceptance Criterion: Configuration modification is rejected when attempted without valid credentials, verified across all configurable parameters.
Source: Risk control


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

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

"The DialysisGuard follows the software lifecycle. The DialysisGuard implements the lifecycle processes. The DialysisGuard adheres to the lifecycle model. The DialysisGuard conforms to the lifecycle framework."

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


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

[User]
Write a SAD section on SOUP risk evaluation and anomaly management for NutriView Food Diary, a Class A Nutritional Tracking Display App. Reference IEC 62304 Clauses 5.3.3, 7.1.3.
Mobile app for manual food logging with nutritional summary display. No dietary recommendations or medical nutrition therapy.

[Assistant] Content: Risk evaluation of SOUP in the NutriView Food Diary follows Clause 7.1.3. Published anomaly lists are reviewed for each SOUP item deployed in the Nutritional Tracking Display App. Anomalies relevant to Personal food logging and nutritional data visualization are entered into the risk management file, and mitigations are implemented where the residual risk is unacceptable.


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

[User]
Write a SDP section on development methodology for Class B for ChestAI Pulmonary Nodule Detector, a Class B AI Pulmonary Nodule Detection SaMD. Reference IEC 62304 Clause 5.1.1.
Cloud AI SaMD analyzing chest CT scans to detect and measure pulmonary nodules, providing CAD overlay for radiologist review. FDA De Novo pathway.

[Assistant] Content: The lifecycle model for the ChestAI Pulmonary Nodule Detector combines iterative development with V-model verification gates required by the Class B classification. Architectural design (Clause 5.3) is formally reviewed, integration testing (Clause 5.6) validates inter-module interactions, and system testing (Clause 5.7) confirms end-to-end behavior of the AI Pulmonary Nodule Detection SaMD.


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

[User]
Expand requirement SRS-FUNC-006: "data logging and retrieval" (Category: functional)
Project: ConsentView Informed Consent Archive | Consent Document Viewer | Class A
Read-only viewing of archived informed consent documents. Web portal for patients and staff to view signed informed consent documents. Read-only document viewer.

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

[User]
Expand requirement SRS-FUNC-002: "data acquisition from PPG sensor" (Category: functional)
Project: DreamLog Sleep Monitor | Sleep Tracking Display App | Class A
Visualizing sleep quality data for personal wellness awareness. Companion app for a wearable sleep tracker. Displays sleep stages, duration, and trends. No alarms, no diagnostic claims.

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

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


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

[User]
Write a SRS section on data processing and transformation requirements for PharmLog Medication History Viewer, a Class A Medication History Viewer. Reference IEC 62304 Clause 5.2.2.
Mobile app displaying a patient's medication history from the pharmacy system. Read-only with no prescribing or interaction checking.

[Assistant] Content: Processing requirements for the PharmLog Medication History Viewer Medication History Viewer cover data acquisition, filtering, computation, and presentation. Each processing step has specified input ranges, output tolerances, and error conditions. Data integrity is maintained throughout the processing pipeline.


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

[User]
Write a SDP section on tool qualification for Class B and C for CogniTest Cognitive Assessment App, a Class B Cognitive Assessment Application. Reference IEC 62304 Clause 5.1.4.
Tablet app administering standardized cognitive screening tests and scoring results. Used by neuropsychologists in clinical settings.

[Assistant] Content: Verification tools for the CogniTest Cognitive Assessment App Cognitive Assessment Application are qualified per Clause 5.1.4. Qualification records document the tool name, version, intended use in the verification process, and evidence that the tool produces correct results. Tools whose output is not relied upon for verification decisions do not require qualification.


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

[User]
Write a SRS section on safety requirements for Class B for AnticoagCalc INR Dose Adjuster, a Class B Anticoagulation Dosing Support Tool. Reference IEC 62304 Clauses 5.2.2, 5.2.3.
Web tool suggesting warfarin dose adjustments based on INR readings and patient history. Clinical decision support requiring physician review.

[Assistant] Content: Safety requirements for the AnticoagCalc INR Dose Adjuster implement the risk control measures identified in the ISO 14971 analysis per Clause 5.2.3. The Class B Anticoagulation Dosing Support Tool includes software-implemented controls for input data validation, range checking, and communication integrity verification. Each safety requirement is traced to the originating hazard.


[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 IEC 62304:2022, with risk management per ISO 14971:2019."

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


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

[User]
Write a TRACE section on risk control coverage verification for BSACalc Body Surface Area Tool, a Class B BSA Calculator Web App. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Web calculator for body surface area using Mosteller and DuBois formulas. Used for chemotherapy dose calculations.

[Assistant] Content: The BSACalc Body Surface Area Tool gap analysis per Clause 5.7.4 and Clause 7.3.2 verifies that the risk control traceability chain is complete. Every hazard in the risk management file that has a software control must trace to a verified requirement in the BSA Calculator Web App. Incomplete chains are flagged and resolved before release.


[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 GasMonitor Anesthetic Gas Logger, a Class A Anesthetic Gas Concentration Logger. Reference IEC 62304 Clause 5.2.2.
Software logging waste anesthetic gas concentrations in operating rooms for occupational safety compliance. Recording only.

[Assistant] Content: Data requirements for the GasMonitor Anesthetic Gas Logger specify retention periods, storage formats, and integrity controls for all persistent data managed by the Anesthetic Gas Concentration Logger. Data integrity is ensured through checksums or cryptographic hashes, and corrupted data is detected before use in any processing function.


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

[User]
Expand requirement SRS-FUNC-002: "real-time data presentation on HL7 FHIR API" (Category: functional)
Project: LabView Results Portal | Laboratory Results Viewer | Class A
Read-only display of laboratory test results for clinician reference. Web application displaying laboratory test results retrieved from the hospital LIS. Read-only viewer with no result interpretation or flagging.

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 LabView Results Portal shall update the displayed values on the HL7 FHIR API at intervals no greater than the specified refresh period.
Rationale: Display freshness is critical for the Laboratory Results Viewer to provide actionable information to the user.
Priority: Mandatory
Acceptance Criterion: Measured display update interval is within 10% of the specified refresh period across 100 consecutive update cycles.
Source: User need


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

[User]
Expand requirement SRS-FUNC-006: "alarm threshold management" (Category: functional)
Project: VitalPulse SpO2 Monitor | Pulse Oximeter Firmware | Class B
Continuous monitoring of blood oxygen saturation and pulse rate with clinical alarms. Bedside pulse oximeter firmware displaying SpO2 and pulse rate with configurable alarm thresholds. Incorrect readings could delay treatment.

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 Pulse Oximeter Firmware shall monitor all active parameters against user-configured thresholds and activate appropriate alarm signals when limits are breached.
Rationale: Timely alarm generation is essential for the Pulse Oximeter Firmware to alert clinicians to abnormal conditions requiring intervention.
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. Expand requirements with description, rationale, priority, acceptance criterion, and source.

[User]
Expand requirement SRS-DATA-003: "data retention period" (Category: data)
Project: AllergyCard Patient Allergy Viewer | Patient Allergy Display | Class A
Read-only display of patient allergy information at point of care. Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

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

[Assistant]
Description: Measurement records stored by the Patient Allergy Display shall be maintained for the configured retention period before eligible for overwrite.
Rationale: Data retention supports clinical trend analysis and regulatory requirements for record keeping associated with the Patient Allergy Display.
Priority: Mandatory
Acceptance Criterion: Oldest data record remains retrievable after continuous operation for the specified retention period.
Source: Regulatory


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

[User]
Write a SRS section on resource constraints and scalability for DermaAssist Skin Lesion Classifier, a Class B Skin Lesion Classification App. Reference IEC 62304 Clause 5.2.2.
Mobile app using a CNN to classify skin lesion images as benign/suspicious. Decision support requiring dermatologist confirmation.

[Assistant] Content: The DermaAssist Skin Lesion Classifier shall operate within the memory, storage, and processing constraints of the iOS + cloud GPU platform. Resource usage requirements are specified with numerical bounds and verified through profiling during system testing of 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 functional requirements overview for InsuPrecise Insulin Pump Controller, a Class C Insulin Pump Controller Firmware. Reference IEC 62304 Clause 5.2.2.
Embedded firmware controlling insulin delivery in a patch-type insulin pump. Incorrect dosing could cause severe hypoglycemia or diabetic ketoacidosis.

[Assistant] Content: Functional requirements for the InsuPrecise Insulin Pump Controller are derived from the system requirements for Automated insulin delivery control with programmable basal rates and bolus calculations and from risk control measures identified in the ISO 14971 analysis. Each requirement specifies a single function of the Insulin Pump Controller Firmware with measurable acceptance criteria.


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

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

"Applicable standards for the BloodBank Manager 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 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 RadOnco Cloud Treatment Planner, a Class C Cloud Radiation Treatment Planning SaMD. Reference IEC 62304 Clause 5.2.2.
Cloud-based radiation oncology treatment planning system using GPU clusters for Monte Carlo dose calculation. Treatment plans directly drive linear accelerator delivery.

[Assistant] Content: External interface requirements for the RadOnco Cloud Treatment Planner Cloud Radiation Treatment Planning SaMD define the data exchanged across each interface boundary: DICOM RT import/export, REST API, web 3D viewer. 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 TRACE section on gap identification and coverage analysis for ScheduleSync Appointment Manager, a Class A Appointment Scheduling System. Reference IEC 62304 Clause 5.7.4.
Web application for scheduling patient appointments across multiple clinics. Administrative scheduling only, no clinical workflow.

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


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

[User]
Write a SRS section on data format and interoperability requirements for AllergyCard Patient Allergy Viewer, a Class A Patient Allergy Display. Reference IEC 62304 Clause 5.2.2.
Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

[Assistant] Content: The AllergyCard Patient Allergy Viewer data format requirements ensure interoperability with external systems connected via HL7 FHIR AllergyIntolerance API. Data structures, encoding schemes, and byte ordering are fully specified. The Patient Allergy Display handles version mismatches in data formats gracefully.


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

[User]
Write a TRACE section on traceability scope including risk controls for CochleaMap CI Fitting Software, a Class C Cochlear Implant Fitting Software. Reference IEC 62304 Clauses 5.7.1, 7.3.2.
Desktop software for fitting cochlear implant sound processors. Maps electrode activation levels and adjusts stimulation parameters.

[Assistant] Content: The CochleaMap CI Fitting Software matrix traces two categories per Clause 5.7.1 and Clause 7.3.2: functional requirements (from system specification through design to test) and risk control requirements (from hazard analysis through SRS to verification). Both categories must show complete coverage before release of the Cochlear Implant Fitting Software.


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

[User]
Write a SDP section on risk management integration into the lifecycle for RoomBoard Digital Signage, a Class A Patient Room Digital Signage. Reference IEC 62304 Clauses 7.1, 7.1.1.
Hospital room digital signage displaying patient name, care team, and daily schedule. Display-only, no clinical data entry.

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


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

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

"Risk control measures are implemented per IEC 62304:2015 Clause 7."

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

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

"Per Clause 5.4.2, each software unit of the LabView Portal has detailed design documentation."

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


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

[User]
Write a TRACE section on risk control coverage verification for AssetTrack Equipment Inventory, a Class A Equipment Inventory System. Reference IEC 62304 Clauses 5.7.4, 7.3.2.
Mobile app for scanning and tracking medical equipment locations via barcode. Inventory management only.

[Assistant] Content: The AssetTrack Equipment Inventory gap analysis per Clause 5.7.4 and Clause 7.3.2 verifies that the risk control traceability chain is complete. Every hazard in the risk management file that has a software control must trace to a verified requirement in the Equipment Inventory System. Incomplete chains are flagged and resolved before release.


[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 FleetTrack GPS Tracking Module, a Class A Fleet GPS Tracking Firmware. Reference IEC 62304 Clause 5.2.2.
Embedded firmware for a fleet vehicle GPS tracking module. Reports position, speed, and geofence events to a central server.

[Assistant] Content: The FleetTrack GPS Tracking Module data pipeline requirements specify end-to-end data flow from GNSS module through processing to output on LTE-M cellular. Requirements include input validation, range checking, unit conversion, and output formatting for Real-time GPS tracking and geofence monitoring of fleet vehicles.


[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 AllergyCard Patient Allergy Viewer, a Class A Patient Allergy Display. Reference IEC 62304 Clause 5.1.1.
Kiosk display showing patient allergy information from the hospital ADT system. Read-only, no modification capability.

[Assistant] Content: The AllergyCard Patient Allergy Viewer 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 Patient Allergy Display 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 RadView DICOM (DICOM image viewer, Class A):

"Configuration management for the RadView DICOM follows Clause 8. Configuration items are identified per Clause 8.1.1, SOUP is identified per Clause 8.1.2, and change control is managed per Clause 8.2. Status accounting is maintained per Clause 8.3."

[Assistant]
Verdict: PASS
Note: Content content is appropriate for the RadView DICOM (DICOM image viewer, Class A). Standards references are accurate.


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

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

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

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