Header Artwork
Header Artwork

ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

A Year of MDR Remediation: Biocompatibility Strategies and Lessons Learned

Published Date: July 14, 2020

Enforcement of the EU MDR was scheduled for May 2020, which would require all submissions for CE marking or renewal to comply with the new regulation. In the years leading up to the deadline, companies have been urgently preparing for the transition through remediation of their files, conducting newly required testing, and screening for CMRs. Then, as SARS-COV-2 spread throughout the globe, a pandemic was declared, and submissions were stalled. The EU responded by extending the deadline for compliance by 1 year. This presentation, co-presented by a medical device manufacturer and a laboratory will discuss strategies for MDR remediation and lessons learned through the process so far with the aim of helping others avoid common pitfalls.

 

Bullet Points:

  • Brief overview of key changes in the new MDR and updated timeline
  • Industry experience of MDR remediation process
  • CRO experience of MDR remediation process at interface of sponsors and notified bodies

 

Presenters: Jennifer Braunschweig, MS – Engineering Director, Medtronic; Matthew R Jorgensen, PhD, DABT; Senior Chemist and Toxicologist, Nelson Labs

Matthew Jorgensen

Matthew Jorgensen

PhD, DABT
Chemistry and Materials Scientist

Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. His analytical chemistry background includes research in organic chemistry synthesizing and analyzing a naturally occurring anti-cancer drug, computational treatment of photothermal spectroscopy, and professionally in a commercial lab. Most of his materials...

Complete the following information to access the webinar