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.
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Latest From Amanda Maxwell
Following the recent vote in the European Parliament, the EU has finally adopted the Medical Device and IVD Regulations that were proposed back in September 2012. The texts, vastly longer and more complex than the three directives they are replacing, will establish a tougher regulatory code for the next decade or more, but where are the likely pressure points for industry and how can manufacturers prepare?
A text has appeared in the Official Journal of the EU that is raising some questions over whether the new EU regulations are in the process of being officially published, an action which would trigger the countdown to them taking effect.
After nearly nine years, MedTech Europe's John Brennan is leaving the medical device and diagnostics trade association. This is a particularly critical time for the industry body and its members, so what has tempted him away at this specific juncture?
Challenges will persist for borderline and combination products under the new EU regulatory structure so manufacturers need to continue to pay close attention when determining the classification of these products.
What is the governance structure under the forthcoming new EU Medical Device and IVD Regulations? Here, Medtech Insight attempts to answer that question and explain how the different organizations and groups relate.
The countdown to the new EU Regulations taking effect is nearly over. Where can you get advice? This article provides you with some useful resources, including conferences and webinars, to help get started.