Sponsored by:
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.
SPEAKERS
Robert Dostert
Sales Manager Medical Devices
DNV
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
AKRA TEAM
Michelle Lott, RAC
Principal & Founder
leanRAQA
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.
|
Share This