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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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:
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.
Upon conclusion of the program, you will be able to:
Who Should Attend
RAC – executive director, Regulatory & Quality Consulting Services
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.
– project engineer
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
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.