Module 14: Design Development and Certification of Medical Devices

17/11/2023

Design Output

21 CFR 820.30( d )

(d) Each manufacturer shall …. define …. design output in terms that allow….evaluation of conformance to design input requirements ….reference…. acceptance criteria and….ensure that those….outputs….essential for….functioning of the device are identified. Design output shall be…. reviewed , and approved ….including the date and signature ….

The Organisation for Professionals in Regulatory Affairs

21

Design Output

The Organisation for Professionals in Regulatory Affairs

22

11