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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
The European Commission is planning to invite comments on editorial mistakes within the EU's new medtech regulations. But will it get more than it is bargaining for?
Implementation of the EU's new highly-detailed Medical Device and IVD Regulations will greatly challenge EU regulatory groups. The work plan signposts the direction ahead, but it will be resource-hungry.
So, you think you have nearly three years to comply with the EU's Medical Device Regulation and five years with the IVD Regulation. Not so. The clock has started ticking and industry has reason to be concerned.
Nearly 16 months after the Brexit vote, uncertainty persists over whether the EU's Medical Device and IVD Regulations will be adopted by the UK. Stakeholders tried to wade through the morass at two recent London meetings.
While UK medtech is absorbed by uncertainties caused by Brexit and the new EU regulations, it is being eyed by the US, which sees opportunities. But are the two cultures too different?
The issue of EU medtech standardization has been on the backburner while the focus has been on the medtech regulations. But developments taking place are now making implementation look even trickier.