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"Great webinar as usual. Very helpful on an organizational level - basically, how to get organized to get the job done. Loved it."

"This was a very knowledgeable group of presenters and there was a wealth of information throughout the webinar. Probably one of the best presentations I've seen, with both a high-level overview and detailed description, including examples on how to apply it all."

"The slides are precise and target the point. The presenters carry a huge knowledge and made the session interesting."

"Thank you. That was very informative; great level of detail!"

"Thank you so much for providing the standard approach tool criteria for PMCF. I am hoping to implement a similar tracking system for my organization and this will very helpful to use as a guide!"

"The RQteam were excellent presenters. They were well prepared, did NOT read from the slides, and provided a lot of top level, yet valuable data."

"The R&Q presenters organized a nice high-level overview of PMCF planning and provided many practical examples of key considerations and options."

"Great speakers. One of the best RAPS webinars of the year."

"It was very informative and presented in simplest forms that helped to understand the concept/content much better."

"Great presentation. Really liked the collaborative presentation from this group."

 


 

Post-market Clinical Follow-up (PMCF) planning and execution can be challenging, requiring input from multiple functions within an organization. This webcast will walk you through a clear process for ensuring your PMCF planning is effective and efficient, beginning with an overview of what's required and how to evaluate your current state against the requirements. The broadcast will cover considerations for potential PMCF activities, including the execution plan and weight each carries with notified bodies in terms of clinical evidence. You will learn why having well-documented justification for how you selected PMCF activities is essential to a successful notified body audit and leave well-equipped with the knowledge to either begin the process or make improvements mid-stream.

This webcast will cover:

  • MDR and IVDR PMCF requirements

  • How to pick the best strategy for your needs (surveys, literature searches, registries, studies, etc.)

  • Considerations for each PMCF activity, including like HIPAA, General Data Safety Protection Requirements, and statistical analysis plans

  • How to successfully execute PMCF activities, including project management, timelines, and budgets while avoiding potential pitfalls

  • How to document strong justifications for your selected PMCF strategies


Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Learning Objectives

Upon conclusion of the program, you will be able to:

  • Develop a PMCF strategy for product portfolio

  • Identify appropriate PMCF activities for specific device/clinical gaps

  • Discuss PMCF plans with a notified body

  • Perform detailed planning for specific PMCF activities for successful implementation


Who Should Attend
  • Clinical, regulatory, and quality team leaders and members responsible for developing PMCF strategies for EU MDR submissions

  • Teams involved in PMCF planning and execution process

  • Decision makers responsible for EU MDR submission budgets


Presenters

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

Morrison_Square-minNancy has over 30 years of quality and regulatory experience in the medical industry with US and global regulatory submission experience. The previous seven 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 been providing EU MDR and IVDR leadership in developing solutions and implementing the regulations at small and large organizations.

 

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

Brian_Hockett_Square

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, PMCF, and QMS.. Brian has a Bachelor of Science Degree in Biomedical Engineering from Case Western Reserve University.

 

Celeste Maksim, Ph.D. – Principal Consultant
Regulatory & Quality Solutions (R&Q)

celeste_square-minCeleste Maksim is a Principal Consultant with Regulatory & Quality Solutions (R&Q) where she helps to provide clients with industry-leading regulatory and quality consulting and engineering services throughout the entire product lifecycle. Her medical device experience spans from research and development of nanoscale electrochemical sensors for emergency medicine applications and nanomaterials that enable drug delivery across the blood brain barrier to regulatory experience in generating regulatory strategies, the development of FDA submissions, including IND, NDA, IDE, and 510(k) submissions, biocompatibility strategy, and EU MDR preparation focusing on post-market surveillance and post-market clinical follow-up. Celeste is Regulatory Affairs Certified (RAC) by RAPS, possesses a Bachelor’s degree in chemistry from Northern Kentucky University, and a PhD in Analytical and Materials Chemistry from Indiana University, Bloomington.