Design Control: From Evolution to Commercialization

Jun 19, 2023 | White Paper |

Are you in the early stages of design development of a product? Or do you need help remediating your Design History File?

This White Paper will provide guidance on the global requirements of design control and the documented evidence needed to meet global regulatory expectations from the feasibility stage to market release.

Before placing a medical device on the market, manufacturers need to ensure the product is compliant, safe and effective for the end user. Following the appropriate regulatory requirements and guidance documents as part of your Quality Management System (QMS) sets the business up with an interrelated set of practices and procedures that evolve into the Design Control process. This process helps in the development, implementation, and application of design control that translate into the device meeting its intended use when transferred to production and released to commercialization.

MEDIcept is presenting this paper as a part of a series of papers focusing on “Right-Sizing Your QMS” discussing QMS Implementation, evaluation and improvement, as well as ways to avoid falling out of compliance. Go back and read some of the earlier QMS series White Papers if you missed them.

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