By name: iec-62304 description: "IEC 62304 medical device software lifecycle framework. Risk classification, software safety classification (A/B/C), design control, verification, validation, and regulatory documentation for FDA/EU MDR submissions." tags: [iec-62304, medical-device, regulatory, compliance, fda, safety, zorai]
Overview
IEC 62304 medical device software lifecycle framework. Software safety classification (Class A/B/C), design control, verification, validation, and regulatory documentation for FDA and EU MDR submissions.
Software Safety Classification
- Class A -- No injury or damage to health (e.g., log viewer)
- Class B -- Non-serious injury (e.g., infusion pump alarm)
- Class C -- Death or serious injury (e.g., radiation therapy planning)
Key Processes
- Design Control -- Requirements -> Design -> Implementation -> Verification -> Validation
- Risk Management (ISO 14971) -- Hazard identification, risk estimation, risk control
- Software Change Management -- Change classification (bug fix, enhancement, new feature)
- Problem Resolution -- CAPA for software defects
- Cybersecurity -- Threat modeling, vulnerability management
Documentation Checklist
- Software Development Plan
- Software Requirements Specification
- Software Architecture Document
- Software Detailed Design
- Software Unit Verification
- Software Integration Testing
- Software System Testing
- Software Release Notes
- Software Maintenance Plan
- Software Risk Management File