Jonathan Gimbel is Director at Regulatory and Quality Solutions (R&Q), an industry-leading regulatory and quality consulting firm that helps medical device and combination product companies bring safe and effective products to market… and keep them there. Jon has worked in the biomedical and medical device area for nearly 20 years, acting as a key member in a medical device startup, a consultant to a wide variety of medical device companies, and as a researcher on both academic and industrial projects. Having a thorough understanding of the ever-changing global regulations, Jon leads R&Q’s CER business unit and has been successful implementing regulations at multinational medical device companies: delivering business-balanced solutions for their business-balanced demands. Jon oversees clinical evaluations completed by R&Q and helps ensure compliance to MEDDEV 2.7/1 Rev 4. Jon also works with companies to develop strategies and plans to meet the new EU MDR requirements pertaining to clinical evaluations and post-market activities. Jon holds a Ph.D. in Mechanical Engineering and BioEngineering, and a Master’s degree in Mechanical Engineering, from the University of Pennsylvania. Jon received his Bachelor’s degree in the same subject from Penn State University.
Conference Track: Post market surveillance under EU MDR – do I have to run a clinical study? What other options do you have to fulfill post market surveillance requirements; including updating CERs
Conference Track: Achieving MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant Clinical Evaluation Reports (CERs): What We’ve Learned From Completing 100+