Post Market Clinical Follow-up (PMCF) and EU MDR - Galen Data

WEBINAR 25 | Post-market Clinical Follow-up (PMCF) and EU MDR | Galen Data
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 Speaker:
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.
✔️ Contact Galen Data for your healthcare connectivity needs:
👉 www.galendata....