Thu, Sep 09|
Medtech Happy Hour: US Regulatory Pathways
How can you manage regulatory clearance in the the US without becoming victim to common pitfalls? Come learn from a regulatory expert as she shares how to navigate these all-too-common traps.
Time & Location
Sep 09, 2021, 3:00 PM – 4:30 PM CDT
About the Event
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.