How can you manage the market clearance process without becoming victim to common pitfalls? Learn how to avoid common mistakes, as well as some helpful tricks of the trade for regulatory submissions. This month’s featured speaker, Angela Mallery, Ed.D. has been in the medical device regulatory profession since 1992 and has been with NAMSA since 2011. Angela has experience in regulatory, clinical and quality as well as 510(k) Submissions, IDE submissions and reports, CERs, FDA and Notified Body interactions/negotiations, Technical File/Design Dossier submissions, and worldwide regulatory strategy. Product areas include Cardiology and Peripheral Vascular devices, general surgical devices and Orthopedic implants.

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