White Paper: Medical Device Design Controls – 6 Best Practices Manufacturers Should Follow for FDA Compliance

• By: ComplianceOnline
• Date: July 07, 2014

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 in order to devise and implement design controls that are compliant, adequate and help in making products that are safe and effective.

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