Implementing Design Controls for Device Manufacturers

• By: Staff Editor
• Date: December 05, 2016
• Source: http://www.fda.gov/

Implementing Design Controls for Device Manufacturers

Design controls are a part of an inclusive quality system that covers the life of a device from the development of device requirements through design, production, distribution, use, maintenance, and ultimately, obsolescence. Design control also applies to the changes to the process design including those occurring after a device has been offered to the market.

This guidance document applies to the design of the medical devices including new designs as well as changes to the existing device designs.

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