A large proportion of Medical Device Manufacturers (MDMs) receive deficiency letters from the Food and Drug Administration (FDA) requesting additional information in their 510k(s), de novo and PMA submissions. Navigating these deficiency letters can be a confusing and downright tumultuous task for MDMs. There are a number of things to consider when submitting and/or responding to the FDA. This webinar will discuss the critical pieces for achieving FDA submission approval.
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Sr Director of Cybersecurity Quality and Safety
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