Design Control Best Practices - Free White Paper

Inadequate design controls continue to be highlighted by the FDA as a major reason for warning letters issued to medical device companies. Manufacturers who have lax controls over design and development of devices also have to recall products as they may endanger user safety. Such actions have a negative impact not just on company profit margins, but also reputation and public trust.

This white paper discusses six best practices that medical device manufacturers should follow

1. Robust and Detailed Design and Development Plan
2. Ensure Design Input Includes All Necessary Elements
3. Carry Out Detailed Design Reviews
4. Verify and Validate Device Design
5. Do Design Transfer Correctly
6. Maintain Complete Design History Files

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