MedCon 2025 has been announced!

April 23 - 25, 2025

Columbus, OH

AFDO RAPS Healthcare Products Collaborative
Presents
MedCon Conference

Back to

2024 MedCon Agenda

April 25, 2024 @ 1:00 pm

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2:00 pm

The Current State of Biocompatibility: Experience and Expectations

Pre Market Track

Listen to the current expectations – directly from FDA leaders – for what should be included in FDA premarket submissions to support device biocompatibility. Also hear updated trends experienced from the perspective of test lab experts as well as industry leaders’ experience with the preparation and submission of biocompatibility data to support both U.S. and EU MDR device submissions.

Moderator

Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS Corporation

Speakers

Jennifer Goode, Biomedical Engineer, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA

Jim Kleinedler, Director, Regulatory Strategy, Medtronic

Thor Rollins, Vice President, Global Market Segment Leader—Medical Device, Nelson Labs

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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© 2024 AFDO/RAPS Healthcare Products Collaborative