"Very informative, really answered my questions on Clinical Data, CER and PMS interaction. Thank you!"
"The webinar was much more informative than expected and the subject matter experts were excellent! Very pleased that I attended."
"Very useful to hear about common audit findings, thank you!"
"I though the webinar was very well facilitated with a wealth of information to help us think through the process of PMS."
"Thank you for offering these educational tools."
"Good webinar. Thank you for providing the slides."
"The slides will be excellent resources. Thank you."
"Great perspective provided from former NB rep! Thanks."
What is ‘sufficient clinical evidence’ and what does it look like as part of PMS?
The EU MDR lays out requirements for a proactive post-market surveillance system that inputs into the ongoing risk management and clinical evaluation processes throughout the device lifecycle. This session will address the expectations for sufficient clinical evidence and the opportunities, risks, and challenges associated with each. Additionally, we’ll cover requirements for PMS planning and PMS reporting for all classes of devices. With significant new requirements for device-specific plans and reports, you’ll need to update your post-market surveillance system with enough time for your staff to implement the changes. The requirements seem to overlap with the CER requirements and risk management activities.
How can you optimize your processes to avoid duplication of efforts and maintain consistency throughout your quality management system? Are you really ready?
Who should view?
This session is designed for regulatory, quality, and supply chain representatives.
Jon Gimbel, Ph.D. – Director and CER Business Unit Lead
Regulatory & Quality Solutions (R&Q)
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.
Ron Sills – Senior Principal Specialist
Regulatory & Quality Solutions (R&Q) (former TUV Rheinland)
Ron recently joined R&Q after collaborating with us on panel discussions, roadshow events, and webinars while a Lead Auditor of TUV Rheinland. He has authorizations for ISO 13485, ISO 9001, MDD, IVDD, CMDCAS and MDSAP. He's also a subject matter expert on sterilization technologies and validation, hygiene and clean room certification, and biocompatibility. In the past Ron has developed clinical evaluation report services, as well as providing expert research services for clients in the medical devices, pharmaceutical, and life sciences industries. He has also worked for medical device companies, including ACMI and US Surgical (Medtronic) as a QA Manager and QMS Management Representative.