Structuring PERs under IVDR

"Excellent presentation. I've seen many IVDR webinars over the years and your presentation was more detailed and meaningful (not reading directly from the reg). Thank you!"

"Great work, I have little experience with drafting CERs and these webinars have helped me learn more."

"This was very helpful, thank you! The speakers were very knowledgeable and presented material very clearly. I feel that I have learned a lot in one hour!"

"Fantastic presentation as always. Thanks for providing these webinars."

"I appreciated that almost no time was spent trying to push your services."

You are probably familiar with the increased requirements for clinical performance under the new IVDR. Whether you are interested in improved strategies for completing Performance Evaluation Reports (PERs) or learning the ropes so you can efficiently and effectively complete your first PER, this webinar can act as a critical guide. The focus points of this webinar will be:

─  How to structure your PERs under IVDR and what elements to consider for PER templates
─  Making sense of and leveraging MEDDEV 2.7/1 Rev. 4 and GHTF guidance documents
─  How to conduct literature searches for PERs
─  A summary of things to consider to enable your organization to comply by the 2022 IVDR date of application

The webinar will also cover issues such as State of the Art, scientific validity reports, and analytical performance reports will be addressed, as well as the role of Post-Market Clinical Follow Up (PMPF).

In the end, attendees of this webinar will leave with the ability to impact their organizations with a clear understanding of the regulations and actionable takeaways to help their organization move towards IVDR compliance.

Presenter

Jon Gimbel, Ph.D. – Executive Director and CER / PER 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 / PER 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.