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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.
This is an On-demand recording from August 2020.
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
- MDR and IVDR PMCF
- How to pick the
best strategy for your needs (surveys, literature searches, registries,
- 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
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
Upon conclusion of
the program, you will be able to:
Develop a PMCF strategy for product portfolio
Identify appropriate PMCF activities for specific
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
Decision makers responsible for EU MDR
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.
– principal specialist