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Meeting your FDA design control needs with requirements and change management
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 podcast will discuss approaches to make that possible. Marty Bakal and Paridhi Verma, speakers.
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By IBMFor 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 podcast will discuss approaches to make that possible. Marty Bakal and Paridhi Verma, speakers.