Vice President US Operations and Principal Consultant
Qserve Group
Mindy has multi-faceted hands-on medical device regulatory experience, having worked for a start-up, a large global company, and two notified bodies before joining Qserve, a medical device consulting company Mindy’s experience as a development engineer, notified body auditor, and technical file reviewer, global certification manager, regulatory affairs manager, consultant, and executive has led to a practical approach in developing and implementing regulatory, quality and clinical strategies and supporting documentation. Over the past 8 years, the focus has been primarily on assisting medical device manufacturers with the implementation of the EU-MDR and EU-IVDR, strategic global strategies, leadership engagement projects, and supporting time-critical responses to regulatory findings.