Jim is a seasoned RA/QA leader within the medical device industry, with over 30 years medical device experience. He has extensive experience with successful 510(k) and PMA submissions & clearances for various Class II and III products and experience gaining clearances in OUS countries (Canada, Korea, Singapore, Taiwan, Brazil, Australia, Thailand, China, Japan, Argentina, Mexico, Costa Rica, Colombia, Ukraine, Turkey, Middle East). He also has direct experience hosting FDA, notified body, and CE Mark audits (creating Tech File), complaint handling, medical device reporting, vigilance and post market surveillance across start-ups, mid-size and large medical device companies.
- Panel: Strategies for Implementing the New EU MDR Requirements
- Tuesday, February 11 • 10:45 AM - 11:45 AM