"Truly appreciated that the data elements were broken up into "data packets." It's a great organizational approach and led to easy understanding."

"The webinar was WAY better than I expected. I would definitely recommend future webinars presented by R&Q. A great job done!"

"I appreciate the thoroughness of the slides since this is so complex and can be hard to follow during the presentation. The slides are a great resource."

"Presenters seemed well-informed and confident of the information they shared. I enjoyed this presentation very much, thank you."

"Thanks for highlighting relationships between these required documents."

"Good webinar: I plan on using the slides to create our template for PMS planning. Thanks."

"Nicely done. Gives me confidence as we begin to partner on CER projects. Thank you."

"This was one of the top five webinars that I have attended. Very informative and well written presentation."

"Excellent and informative webinar! Thank you."

"I thought you did a great job with the visuals!"

"This was a very good webinar. Appreciated! Thank you!"

CEP, CER, PMS Plan, PMS Report, PSUR and SSCP: With a variety of new requirements detailed in EU MDR, integrating the clinical, regulatory, and post-market documentation is a difficult and confusing task for both small and large organizations. There are overlapping requirements and consistent information needs to be included in a variety of plans and reports.

R&Q will explain how the data inputs and outputs for these documents are interrelated and provide guidance on how to share information throughout the organization to streamline processes and ensure consistency.

Presenters

Nancy Morrison – Executive Director, Regulatory & Quality Consulting Services
Regulatory & Quality Solutions (R&Q)

Nancy has over 25 years of quality and regulatory experience in the medical industry with US and global regulatory submission experience. The previous five years have been with R&Q working with start-up, mid-size and multi-national medical device and combination product companies. Nancy has a Bachelor of Science in Mathematics and an Advanced Certificate in Regulatory Affairs along with RAC certifications for the US and EU. Nancy has the ability to build collaborative relationships with stakeholders to utilize regulations to identify opportunities that provide compliant and effective business solutions.

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. 

Brian Hockett – Project Engineer
Regulatory & Quality Solutions (R&Q)

Brian Hockett is a Project Engineer at Regulatory & Quality Solutions (R&Q). Brian is a skilled medical device professional with experience in design, development, risk management, regulatory submissions, and quality management systems. He has worked in both startups and large medical device organizations, and has been a key member of corporate integration and remediation teams. Brian has helped lead quality system updates and implementation for ISO certification, FDA and notified body audit preparation and defense, as well as directed design and development efforts, and design quality assurance projects.

Brian currently works with companies to develop strategies and plans to meet the new EU MDR requirements for their technical documentation, post-market surveillance, and QMS. Brian has a Bachelor of Science Degree in Biomedical Engineering from Case Western Reserve University.