June 5, 2024

MedTech Event: EU MDR Regulatory Updates and Best Practices for Evidence Management

Agenda – June 5, 2024

 

12:00 pm – 1:00 pm

Lunch + Registration

 

Status of EU MDR 2017/745 and Key Learnings from initial EU MDR Certification

Dr. Bassil Akra, Founder and CEO at AKRA Team GmbH
Dr. Matthias Fink, Senior Clinical Consultant at AKRA Team GmbH

 

NB Update: Clinical Evaluation Assessment Process

Richard Holborow, Global Head of Clinical Compliance at BSI Notified Body (NL) & BSI Approved Body (UK)
Gretchen Adams, Technical Director at DEKRA Certification BV

 

Best practices for literature search and evidence management

Peter O’Blenis, CEO at DistillerSR
Dr. Matthew Cooper, CEO at Peak Cardiovascular

 

Best Practices for RWE in EU and US Markets

Amelia Hufford, Co-founder and SVP, Clinical and Regulatory Science Operations at 3Aware

 

5:30 pm – 6:30 pm

Networking hour

Why You Should Attend

  • Understand the current status, key provisions, and timelines of the EU MDR, and how to develop a strong strategy for compliance and market readiness.
  • Learn about the latest updates from the Medical Device Coordinating Group (MDCG) on clinical investigation guidance, including how these revisions impact the planning and conduct of clinical trials.
  • Gain clarity on notified body’s expectations for clinical evaluation requirements under the EU MDR, including methodologies for assessing clinical data and demonstrating device safety and performance.
  • Hear firsthand experiences, key lessons, and practical insights from organizations that have successfully navigated the initial EU MDR certification process.
  • Explore effective strategies for conducting literature searches and appraising relevant clinical data for EU MDR clinical evaluation requirements.
  • Discover how RWE can be leveraged to support clinical claims, including the nuances and best practices for RWE utilization across the US and the EU markets.

Confirmed Speakers

Bassil Akra

Bassil Akra

Founder & CEO at AKRA Team GmbH
Richard Holborow BSc (Hons) MSCST RCCP

Richard Holborow BSc (Hons) MSCST RCCP

Global Head of Clinical Compliance for BSI Notified Body (NL) & BSI Approved Body (UK)
Dr. Matthias Fink (AKRA Team)

Dr. Matthias Fink (AKRA Team)

Senior Clinical Consultant at AKRA TEAM GmbH
Amelia Hufford

Amelia Hufford

Co-founder and SVP, Clinical and Regulatory Science Operations of 3Aware
Gretchen Adams

Gretchen Adams

Technical Director at DEKRA Certification BV
Dr. Matthew Cooper

Dr. Matthew Cooper

CEO at Peak Cardiovascular
Peter O'Blenis

Peter O'Blenis

CEO at DistillerSR