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
Little has been forthcoming from the European Commission about actions it is taking to get the new European regulatory framework for medical devices and IVDs ready on time. Now the European Parliament wants some answers.
Precious few details are available on the readiness of necessary structures and documents to support the EU's new Medical Device and IVD Regulations. But the current agenda of the Medical Device Coordination Group gives some insight.
There are hurdles to compliance with the EU Medical Device and IVD Regulations – but companies must jump them now. A look at why it's time for manufacturers to throw themselves into MDR/IVDR compliance, even if they will sometimes need follow their instinct rather than formal guidance.
It looks as if the EU medtech regulatory system could survive intact in the UK, given terms of the UK blueprint for its future relationship with the EU after separation. But a storm of controversy must be navigated first.
The EU medtech regulatory system is coming under fire again in the UK, being blamed for the vaginal surgical mesh scandal as action is taken to limit procedures. But this is a global problem.
Theresa May finally made a Brexit plan, but its effects have been explosive. One consequence: the UK has a new health secretary. What do the latest cabinet changes mean for health products, and why is certainty still so far away?