FDA design control and FDA design process for Medical Devices

Cquest18 Jun, 2021Computer & Internet

Design controls are defined as an interrelated set of practices and procedures incorporated into the design and development process. FDA design controls make a systematic assessment of the design an integral part of development. With design control, any deficiencies in design input requirements or discrepancies between the proposed designs and requirements are detected early and corrected immediately in the development process. Design controls intend to increase the chances of transferring the design to production, without much difference, into a device suited for its intended use.