Overview of Medical Device Design Controls in the US

Posted 01 February 2011 | By Nini Murthy, MS, RAC 

Design controls are a regulatory requirement for medical devices. In the US, compliance with the design controls section of 21 Code of Federal Regulations (CFR) Part 820.30 of the Quality System Regulation (QSR),1 which applies to the design and development of new products, and changes to existing devices, is mandatory for both investigational and commercial medical devices. Because the regulation must apply to so many different types of devices, it does not prescribe in detail how a manufacturer must develop a specific device. Rather, the regulation is somewhat flexible; instead of specifics, it provides the framework that all manufacturers must follow by requiring that they develop and follow procedures and fill in the details that are appropriate to a given device. For example, the design control regulation requires documentation of device specifications. Different companies utilize terms such as Functional Requirement Specifications (FRS), Product Requirements Definition (PRD), etc., in their procedures.

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