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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The FDA has focused efforts in supporting industry by providing the guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process’” and the draft guidance “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin”.
This presentation will provide a practical approach to aid regulatory professionals drafting a biocompatibility risk assessment to use in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Exemption (IDE) Applications, Premarket Notifications (510(k)s), and De Novo requests for medical devices.
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Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Regulatory professionals in biologics, engineering, and medical devices.
Melissa PaffenrothSenior Regulatory Consultant
Melissa Paffenroth, PhD is a forward-thinking professional with 11+ years of success in regulatory affairs and 5+ years of success in research and development. She is experienced in medical devices and IVD medical devices.
As a Senior Regulatory Consultant, Melissa is an integral part of the MEDIcept team. She leverages her technical skill set into her regulatory work. Before joining MEDIcept, she was the Regulatory Manager at ZOLL Medical and ACE Surgical Supply Co., Inc., a subsidiary of Henry Schein. She also held regulatory positions at Waters Corporation and Smith & Nephew in the Endoscopy Division.
Meliss holds a Doctorate of Science in Biomedical Engineering and Biotechnology, Master of Science in Biomedical Engineering and Biotechnology and Bachelor of Science in Plastics Engineering from The University of Massachusetts Lowell.
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