FDA & ISO 62304 Software Documentation Requirements

FDA & ISO 62304 Software Documentation Requirements define standards for medical device software safety, risk management, and lifecycle processes. These FDA & ISO 62304 Software Documentation Requirements ensure compliance, quality, and regulatory approval.

Key Difference:

• FDA: Basic or Enhanced documentation based on risk.
• ISO 62304: Class A, B, C based on severity of harm.

Core Requirements:

• Software development plan & description
• Risk management (aligned with ISO 14971)
• SRS, architecture, and design documentation
• Verification, validation, and testing
• Version control & change management
• Problem resolution & traceability

FDA & ISO 62304 Software Documentation Requirements focus on safety, risk control, and full lifecycle documentation, ensuring reliable and compliant medical device software.