Join us for a comparison of how medical device clinical data requirements differ between the EU and US. The speakers will highlight the key differences and discuss the practical implications of these differences. Examples and strategies for compliance with these divergent requirements will be provided.
Regardless of your market entry plans, this webinar will help you understand and address these differing requirements.
Key Topics will include: • Critical differences between clinical data requirements in the EU and the US. • Practical implications of these differing clinical data requirements • Real-world examples of how these differences can affect market entry
Plus, an update on the revision of ISO 14155, development of the clinical evaluation standard, and revision of the European guidance on clinical evaluation.
Speakers: • Maria Donawa, MD: President of Donawa Lifescience • Tom Melvin: Associate Professor of Medical Device Regulatory Affairs, Trinity College Dublin • Moderated by David Filmore: Executive Editor, Market Pathways (MedTech Strategist)
Date and Time: September 25 at 10:00 AM Eastern Time / 4:00 PM Central European Time* *Recording available to all registrants.
Why Attend: • Understand the nuances of the different clinical data requirements in the EU and US. • Benefit from the experience of specialists in the clinical data area. • Get your questions answered by subject matter experts.
Don’t miss this opportunity to stay ahead in the ever-evolving field of medical device regulations. Register today and secure your spot for this must-attend webinar!
