Tuesday, June 5; 12 PM – 1 PM
Speakers: Jon Gimbel, Director and CER Business Unit Lead, Regulatory & Quality Solutions (R&Q)
Rina Sant, Clinical Investigation and Evaluation Board Member, EU MDR Global Task Force Clinical Subcommittee
Speaker introduction and moderation: Lisa Casavant, Executive Vice President, Regulatory & Quality Solutions (R&Q)
MEDDEV 2.7/1 Rev. 4 and the new European Union Medical Device Regulation (EU MDR) have raised a lot of questions in the regulatory and clinical affairs communities. This panel will feature medical device manufacturers and device consultants who we are in the unique position to have the opportunity to create CERs for products in a wide range of clinical specialties being submitted to a variety of notified bodies.
Our panel has seen it all and will share the most impactful lessons learned from every aspect of the CER process. From a strategy for finding data to establish equivalence to completion of state of the art analysis, the speakers have encountered obstacles and found solutions, and will share them with attendees so they can learn from experience and apply methods in their own organizations.
Speakers will discuss case studies featuring a multitude of challenges to share. For example, what should you do with a low-risk device that has no clinical data? And what about a device that will be up-classed from II to III? How will the new EU MDR impact your clinical evaluations?Speakers will share actionable tips and tricks gleaned from our first-hand experience and lessons learned.
Attendees will return to their organizations with ideas and recommendations to impact their decisions and plans on how to address the requirements.