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
Medtech notified bodies need to monitor PIP liability issues again as France's top court weighs in. Will it trigger a reopening of the TÜV Rheinland liability case? And what might it mean for notified bodies in general?
The new executive group chair of the Competent Authorities for Medical Devices will help steer EU medtech through one of the trickiest times in its regulatory history, as the key national authorities group loses its UK lead.
With just over one week to go until the General Data Protection Regulation (GDPR) fully applies, are you sure your company is fully compliant? Anything overlooked? Attorneys Renzo Marchini and Robert Fett answer Medtech Insight's questions.
Belgium is introducing new registration requirements for medical device and IVD operators June 17, ahead of the full application of the EU's medtech regulations and new Eudamed medical device database.
How many experts can member states appoint to the new EU's MDCG governance group? And what say will industry have within this group? Publication of new rules answers these questions and more.
The demand for medtech regulatory professionals has escalated recently, especially in the EU with the new Medical Device and IVD Regulations. Will upcoming survey results into regulatory professional salaries show big increases?