A lifetime dedicated to passionately following medtech regulations seems a big claim, but Amanda Maxwell, regulatory affairs editor, wears the badge and has a loyal list of followers. She still remains as passionate about the implications of changing requirements as 30 years ago when analysing the drafting of the first EU medical device and IVD rules. She tirelessly picks through the draft and existing requirements and the implications of the background debate, to bring you the reality of what the latest developments and discussions mean for you. Amanda knows where to get the vital information, who can offer the best inside knowledge and how to get it to readers quickly. She is well respected in the industry and has a history of moderating and chairing at many high-profile meetings in the EU and the US ( MedTech Forum (EU), AdvaMed (US), DIA (EU and US)), and a strong network of contacts among regulators, consultants, lawyers and EU institutions. She has also been active in consulting and training companies in EU medical device regulations. Amanda has been known to pick up stories while swimming in the Aegean, and there are rumours of her renting a window cleaning scaffold outside the European Commission, but she won’t comment on this and would not recommend anyone to try it!
When not writing, Amanda is a strong well-being advocate and loves health and wellness apps. She rarely sits still and loves to be out and about, actively participating in life with family and friends.
Latest From Amanda Maxwell
Those marketing products covered under the EU’s MDR and IVD Regulations have plenty of reading this month to help them prepare. More details have also emerged about the UK’s regulatory future.
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?
The European Commission has finally published detailed guidance on the EU IVDR’s classification rules. The IVDR’s completely new classification regime means guidance is urgently needed.
Do you know how to avoid the pitfalls when it comes to clinical evidence under the MDR? Or whether evidence gathered outside the US counts? Amie Smirthwaite of Maetrics answers these and other pivotal questions in this third and final part of an interview series with Medtech Insight.
Maetrics’ Amie Smirthwaite explains the fundamental differences in clinical evidence expectations under the MDR compared with the MDD in part two of a three-part interview.
Clinical evidence requirements are among the biggest challenges for manufacturers meeting the requirements of the EU’s new Medical Device Regulation. Maetrics’ Amie Smirthwaite explains how manufacturers should transition from the one to the other in part one of a three-part interview series with Medtech Insight.