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
UK companies, and firms in the EU dealing with them, need to be prepared to renegotiate their relationships in the context of Brexit, lawyer Alison Dennis tells the sector.
The EU association representing the medical imaging, radiotherapy, health IT and electromedical industries appoints a new president.
It's a vital entity now, but what is the longer-term future of the EU's Competent Authorities For Medical Devices (CAMD) group once the new Medical Device and IVD Regulations take full effect?
The vast majority of medical device and IVD manufacturers are dependent on their notified bodies to grant them certificates of conformity to the EU's medtech rules. But what happens when they don't see eye-to-eye?
Much speculation and little certainty means notified bodies and Brexit continue to dominate headlines as one UK notified body is phased out. News and insights on single-use device reprocessing and health technology assessments also attracted attention last month.
Plans for the second meeting of the Medical Devices Coordination Group reflect topics that are high on the current EU agenda.