AMPLEXOR Webinar on demand desktop-monitor.png

Focusing on the Details: MDR PART II - Translations Requirements

Now, language requirements are part of the MDR  - with a requirement that labeling must be in the national language and "clearly comprehensible to the intended user or patient".

This significant change will impact the way organizations approach translations.

Watch now for free


Yvonne Middlefell

Yvonne Middlefell
A highly experienced regulatory professional with more than 29 years’ experience in Global Regulatory Affairs, Quality and R&D, 
Yvonne Middlefell, RAC, FRAPS, is currently the Executive Director of Stellar Regulatory Consulting, LTD.  She has in-depth knowledge across a broad range of disciplines, including medical devices, in-vitro diagnostics, biologics, pharmaceuticals and OTC. Yvonne has written and submitted more than 30 510(k) submissions, PMAs, IDEs and BLAs and established RA functions for multinational organizations. She holds a 2:1 Hons degree in Science, Technology and Management from the Open University, United Kingdom.