Clinical Data Requirements: EU vs. US – Critical Differences and Strategies

On 25 September 2024, Donawa Lifescience President Dr. Maria E. Donawa spoke at the webinar titled ‘Clinical Data Requirements: EU vs. US – Critical Differences and Strategies’. Dr. Donawa was joined as a speaker by Tom Melvin, Associate Professor of Medical Device Regulatory Affairs, Trinity College, Dublin.

The webinar was hosted by MedTech Leading Voice and was moderated by David Filmore, Executive Editor, Market Pathways.

Key Topics included:

• 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
• An update on the revision of ISO 14155
• Development of the clinical evaluation international standard, and
• Revision of the European guidance on clinical evaluation

MedTech Leading Voice can be accessed from here.