Barbara Atzenhoefer

Barbara Atzenhoefer currently serves as a Senior Product Development Strategist at NAMSA. Throughout her 25+ years in the medical device industry, Barbara has held executive and management positions in regulatory and clinical affairs and quality systems. In 2003 she joined NAMSA, specializing in regulatory affairs. Her regulatory experience includes authoring over 70 U.S. FDA applications, >100 EU Technical Files, and numerous international license applications.

Conference Track: Comparing and Contrasting Global Regulatory Requirements for Clinical Evaluation Reports (CERs). Highlighting: Japan, China, Europe, Australia and ASAEN