Sponsored Webcast: Strategies for Successful PMCF Planning and Execution

Postmarket 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

Speakers

Nancy Morrison, RAC – executive director, Regulatory & Quality Consulting Services

Regulatory & Quality Solutions (R&Q)

Nancy has over 30 years of quality and regulatory experience in the medical industry with US and global regulatory submission experience. She has spent the previous seven years with R&Q, working with start-up, mid-size and multi-national medical device and combination product companies. Nancy specializes in EU MDR and IVDR leadership, developing solutions and implementing the regulations at both small and large organizations. She holds a Bachelor of Science in Mathematics and an Advanced Certificate in Regulatory Affairs along with RAC certifications for the US and EU.

Brian Hockett – project engineer

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 Hockett is currently a Project Engineer at Regulatory & Quality Solutions (R&Q), working with companies to develop strategies and plans to meet the new EU MDR requirements for their technical documentation, postmarket surveillance, and QMS. He holds a Bachelor of Science Degree in Biomedical Engineering from Case Western Reserve University.

Celeste Maksim, Ph.D. – principal specialist

Regulatory & Quality Solutions (R&Q)

Celeste Maksim is a Principal 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.