What you should know when designing a PMCF Plan for your Medical Device

January 7, 2020

An on-demand webinar on the things you should know as you design the Post-Market Clinical Follow-up plan for your Medical Device will be taking place on the 16th of January. Hosted by Jon I. Bergsteinsson ,VP of Business Development for SMART-TRIAL together with Wiebe Postma, Senior Consultant and CRO Lead for Qserve Group.

According to the KPMG/RAPS survey results published in September 2019, 43% of Medical Device respondents had not started updating their Post-Market Surveillance (PMS) procedures, and 13% didn't even have a PMS strategy in place.

A PMCF plan plays a big role in the new requirements for PMS introduced by the MDR. But the lack of guidance from the European Commission leaves many uneasy and unsure of how to implement a strong PMCF plan to comply with the regulations.

The MDR is very clear on what a PMCF plan should include, but the choice of strategy can greatly vary from one device to another. If you are looking for guidance on your choice of strategy for your medical device PMCF plan, this webinar is for you.

In this webinar the hosts will go through:

  • How your PMCF strategy can impact the rest of your portfolio
  • How ethics interplay with your PMCF plan
  • How to justify PMCF data results
  • How you demonstrate sufficient data quality
  • Why you should not rely too much on key opinion leaders (KOL)

About the webinar hosts

Jón I. Bergsteinsson, M.Sc. Biomed. Eng. is the VP of Global Business Development and the co-founder of SMART-TRIAL, he also served as the CTO until 2017 where he paved the way for the platform's quality standards, data security, and compliance. With a strong technical background, and 10 years of experience in clinical informatics, research, and medical devices, Jón's primary mission is to share valuable insights and know-how on clinical data management with the MedTech industry.

Wiebe Postma, M.Sc. Immunology & Ph.D.Molecular Biology is part of the Clinical Affairs team at Qserve, his area of expertise is in Clinical Strategy development, Clinical Evaluation, and Clinical Investigation. His main activities are setting up international clinical operations and study management for all device classes under the Medical Device Regulation, with a focus on non-active high-risk devices.

Register today and get access to this unique and free webinar, brought to you by SMART-TRIAL in partnership with Qserve Group.