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Complimentary Webinar

November 30, 2021 | 11:00 a.m. - 12:00 p.m. ET

EU MDR Lessons Learned

Join us for a panel discussion on the EU MDR lessons learned since the May 26th deadline requiring all new medical devices to meet Regulation (EU) 2017/745. The webinar will cover the key concerns, challenges and common non-conformities that manufacturers, consultants and notified bodies are seeing from the application stage to final approval.  


Robert Dostert
Sales Manager Medical Devices

Robert has 20 years of experience in the Healthcare industry. At DNV, Robert collaborates with a team of more than 150 experts, who serve the medical device industry worldwide. Robert is driven to ensure DNV's clients are provided quality services including assessments, CE Marking, software tools, training, and technical expertise to successfully bring their products to the healthcare market in a safe and timely manner.

Dr. Bassil Akra
CEO & Owner

Dr. Akra is a regulatory expert supporting his clients in the field of medical device, in-vitro diagnostic, and combination devices. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in the various European discussion and guidance documents preparation. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standards.

Michelle Lott, RAC
Principal & Founder

Michelle Lott is founder and principal of leanRAQA (leanraqa.com). She's supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services – and grief counseling, as dealing with regulators can be emotionally draining. Michelle served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP), holds a BS in Chemistry from Troy State University and is a Certified Executive Leader in Regulatory Affairs from RAPS and Kellogg University.

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