Design review is a part of the quality management process that can get complicated. We wanted to explore why this is and how organizations can get on top of managing their design reviews.
LEXINGTON, Mass. (PRWEB) May 02, 2018
Design Controls are required by FDA to establish reasonable assurance of safety for all medical device submissions. Design reviews allow organizations to evaluate their device design during product development to ensure quality and compliance. This new white paper discusses the importance of these reviews and how to approach them.
“Design review is a part of the quality management process that can get complicated,” says David Cronin, CEO of Cognition Corporation. “We wanted to explore why that is and how organizations can get on top of managing their design reviews.”
The white paper looks at the Design Review regulation—as part of the overall Design Controls requirements—and breaks it down into functional requirements for product development teams. As well, it attempts to address the language of the regulation and develop tangible interpretations teams can use.
“With the Design Review regulation in particular, the language used leaves room for interpretation,” says Mr. Cronin. “Our goal with this white paper was to look at some of the ways to interpret it and establish some initial ways of understanding of how to approach it.”
This latest white paper from Cognition leverages industry knowledge and collaborative efforts with professionals from the medical device, pharmaceutical, and combination products industries. This is part of Cognition’s ongoing effort to provide support and resources for product development organizations worldwide.
“At Cognition, we understand many of the struggles that medical technology and life sciences organizations go through,” says Mr. Cronin. “Our resources, products, and expertise all aim to help understand and overcome these struggles.”
The case study is available for download here.
About Cognition Corporation
Cognition Corporation, based in Lexington, Massachusetts, has offered solutions for product development compliance for more than fifteen years. Cognition's core product, Cognition Cockpit", is used by thousands of users worldwide to manage their product development process and meet regulatory, performance, re-use, and time-to-market goals. For more information, visit http://www.cognition.us or call (781) 271-9300.