Uwe Degenhardt

Director, Quality Compliance, Edwards Lifesciences and, Timothy W Lee, Medical Devices Account Manager, Northwest US, BSI

Uwe Degenhardt

Director, Quality Compliance, Edwards Lifesciences and, Timothy W Lee, Medical Devices Account Manager, Northwest US, BSI

Biography

Uwe is currently working in the Corporate Department as Director, Quality Compliance. In this role he is overseeing external agencies inspections according to applicable standards and regulations like ISO 13485, 21 CFR 820, CMDR, MDD etc. while also performing corporate audits. Members of his department oversee the Clinical Compliance program covering 21 CFR 50, 54 & 56 and Good Laboratory Practice according to 21 CFR 58. Before joining Edwards Lifesciences 2.5 years ago, Uwe was working 17 years for one of the leading Notified Bodies, TÜV SÜD. Over the course of his career in TÜV SÜD he has held different roles as Test Engineer for Active Medical Device, Lead Auditor for various standards and regulations, 510(k) Reviewer, Quality Unit Representative, and Division Manager. Uwe holds a M.S. degree in Biomedical Engineering from Technical University Dresden, Germany.

All session by Uwe Degenhardt

Medical Device Single Audit Program (MDSAP)

10:45 am - 11:45 am
Imperial Ballroom C