Medical Device 2021 - Understanding Medical Device Design Controls What, Why, and How

This Design Control course is US-focused. The participants will gain a fundamental understanding of how medical devices are regulated in the US: the main legal basis, FFDCA (21 U.S.C. 301) and the specific Medical Device Quality Systems Regulation, and the comparison/contrast of the GMP
Fortunately, Alan Golden Principal at Design Quality Consultants, LLC with over 30 years’ experience working in the medical device industry will focus on introducing the attendees to the regulatory requirements stipulated under the US Medical Device
My background and experience
Why design control
Purpose of design control
Speaker:
Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories.