Post-Market Clinical Follow-Up (PMCF) and EU MDR

Galen Data Medical Device Innovation Webinar Series Presents:   

Post-Market Clinical Follow-Up (PMCF) and EU MDR  

Description:  The European Medical Devices Regulation (EU MDR) is a new set of regulations that govern medical devices’ production and distribution in Europe. The EU MDR requires more stringent clinical evidence for medical device manufacturers than previous guidance. As a result, many medical device manufacturers will need to collect more evidence via clinical investigations or other post-market clinical follow-up (PMCF) activities to obtain and renew their CE Mark certifications.  

Discussion Topics: 

The PMCF plan and general vs. specific PMCF activities 

Which PMCF activities can be relevant? 

Pros and cons of each 

PMCF activity Selecting the ideal activity for your device  

About our Guest:  Jón Ingi Bergsteinsson, M.Sc. in Biomedical Engineering, founder and Director of EMEA Sales at SMART-TRIAL by Greenlight Guru, where he helps MedTech companies bridging the gap between their devices and clinical data. As the technical founder of SMART-TRIAL he previously served as the CTO where he paved the way for the platform’s quality standards, data security, and compliance. With a strong technical background, and over 10 years of experience in clinical investigations, eClinical software, and medical devices, Jón is mostly occupied with sharing valuable insights and know-how on clinical data collection with the MedTech industry.