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Meeting your FDA design control needs with requirements and change management

On-demand Aired live: November 28, 2012

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For most medical device companies, the design control requirements of the FDA, as defined in 21 CFR Part 820, are fundamental to the business of developing products. The challenge is how to ensure that you remain compliant to these regulatory needs while reducing the overhead in doing so. Ideally, you want to make compliance just part of "how we do business around here", and, in effect, invisible to the practitioners. This webcast will discuss approaches to make that possible.

The major theme in compliance with 21 CFR 820 is design compliance, making sure that what your build matches the user needs. We will show the careful use of requirements management approaches, applied to all work products, greatly improves your ability to do that, and, most importantly, to show that you have done it. Implicit in this is the need to manage changes, to requirements and other work products, in such a way that design compliance is maintained. We will also discuss how this can be done.

Presenter:
Keith Collyer
Dr. Keith Collyer is an IBM Rational thought leader with over 30 years developing and delivering systems and software and assisting organizations with process improvement and requirements management in a wide range of organizations.

Deric Merino
Deric Merino is a Rational Specialty Architect with IBM/Rational. Over his 10+ years experience with formal requirements management tools, he has been involved with multiple implementations in the medical device industry.

Moderator:
Jim Turley, Open Systems Media