Major Regulatory Compliance Challenges for the Non-European Industry
Mindy Mc Caan
VP Regulatory Compliance, Qserve Group, USA
Mindy has multi-faceted medical device regulatory experience, having worked for a start-up, large global company and two notified bodies before joining Qserve, a medical device consulting company Mindy’s hands-on experience as a development engineer, notified body auditor and technical file reviewer, global certification manager, and executive has led to a practical approach in developing and implementing regulatory, quality and clinical strategies and supporting documentation.
The new European regulations have presented the medical device industry with new challenges in order to ensure compliance to the MDR/IVDR and continue placing medical devices on the EU market. This session will identify some unique key challenges experienced by non-European medical device manufacturers in preparing for compliance to the MDR/IVDR, and the lessons learned and/or strategies being used by medical device manufacturers to address these challenges.