Kim is an experienced Medical Devices and InVitro Diagnostics Executive Vice President with 26 years of working at the U.S. FDA Center for Devices and Radiological Health (CDRH) and working with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes medical device regulatory services and recently developed a formal Education/Training business, as well as an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body in Ireland for EU IVDR/MDR Designation.
- Panel: Strategies for Implementing the New EU MDR Requirements
- Tuesday, February 11 • 10:45 AM - 11:45 AM
- Tech Talk Panel: FDA's Shift from 21 CFR 820 Toward ISO 13485: How It Will Impact You
- Wednesday, February 12 • 8:30 AM - 9:30 AM
- Explore the Convergence of Global Regulatory Trends Impacting Quality Management Systems (QMS): Risk Management, Clinical Evaluations, and Post Market Surveillance
- Wednesday, February 12 • 9:45 AM - 10:30 AM