About this Framework
IEC 62304:2006 (amended 2015) defines software lifecycle requirements for medical device software, covering software development planning, requirements analysis, architectural design, unit implementation, integration and verification, system testing and maintenance. Compliance is required for FDA 510(k) pre-market submissions and EU MDR/IVDR technical documentation. It establishes a documented software development lifecycle with risk-based safety classification (Class A: no injury risk; Class B: non-serious injury; Class C: serious injury or death).
Key Control Domains
Software Development Planning
Software Requirements Analysis
Software Architectural Design
Software Detailed Design
Software Unit Implementation & Verification
Software Integration & Testing
Software System Testing
Software Release Management
Software Maintenance
Problem & Change Resolution
Who Needs This?
- Medical device software developers and manufacturers
- Regulatory affairs teams preparing FDA/MDR submissions
- Software as a Medical Device (SaMD) companies
- In vitro diagnostic (IVD) software developers
- Healthcare software outsourcing vendors and contractors
Compliance Benefits
- FDA pre-market submission compliance for software-containing devices
- EU MDR and IVDR technical documentation fulfilment
- Reduced risk of post-market software-related device recalls
- Internationally recognised software quality lifecycle standard for medical context
Official Reference
IEC 62304 Standard — IEC Official Site
https://www.iec.ch/
Assessment Details
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