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EU Medical Device Regulation:
Defining Sufficient Clinical Evidence for Your Device

Two-part MDR Series: Stay for One, or Both

When: Tuesday, June 11 | 1:00 pm - 2:30 pm 
Where: Room 49 - Product Lifecycle Management Track
Level: Intermediate, Advanced
Participant Type: Research & Development, Product Development, Regulatory/Clinical Affairs, Sales & Marketing

 

Description

Do you have sufficient clinical evidence to keep your orthopedic products on the market? With EU’s Medical Device Regulation looming, companies need to examine their approach to clinical data and clinical evaluation to ensure that they’re meeting the more stringent equivalence requirements. Dr. Fink will review the essential regulatory changes, share the trouble areas for orthopedic device manufacturers and leave plenty of time for attendees to pose questions to a Notified Body.

Attendee Takeaways

  • Understand the impact of the clinical evidence requirements
  • Understand expectations of clinical evaluation reports
  • Learn the enhanced postmarket expectations

Speakers

Matthias Fink, M.D., is a board certified surgeon and medical professional with over 17 years of experience in orthopedic, trauma and reconstructive surgery. He has expert knowledge in the field of orthopedic implants and cardiac devices. Dr. Fink has worked as a Clinical Reviewer for the Clinical Centre of Excellence for TÜV SÜD Product Service since 2016 and as the Team Leader for the ortho and trauma team since 2018. He serves as a medical expert for the Clinical Audit Team within and outside of the European Union, as well as a presenter and panelist at national and international conferences. Dr. Fink has the ability to build successful internal and external relationships, enabling optimization and streamlining of operational and clinical processes.

 

Recommend Reading

Your EU Medical Device Regulation Guide