Clinical Data and Post-Market Compliance Under the MDR

This webinar will help you gain a better understanding of insights from Emergo’s medical device clinical research team on the role of PMCF studies in MDR compliance and what it takes to conduct a PMCF study that should be acceptable to all stakeholders.

Learning objectives:

• If and when to conduct a PMCF study
• Medical Device Coordination Group (MDCG) requirements
• How PMCF studies can address the MDR data gap
• The relationship between post-market surveillance, PMCF and risk management
• PMCF pre-approval process
• PMCF study structures and methodologies, including the place for retrospective studies
• ISO 14155 and GCP requirements  

About the presenter:

Dietmar Falke, Senior consultant, clinical research, Emergo by UL

Dietmar Falke, PhD heads the Clinical Research team at Emergo by UL. For more than 18 years, Dr. Falke has been involved in or responsible for conducting pharmaceutical and medical device clinical studies. He has wide experience in clinical study product management, from trial design to the generation of the final report, including submission to authorities and ethics committees. In addition, he has significant experience in the interpretation and presentation of study results. Dr. Falke holds a PhD in Microbiology from the Eberhards-Karls-University of Tübingen in Germany. Prior to entering clinical research, he spent several years as a post-doctoral fellow in the department of pharmacology at the University of North Carolina.