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
How do the EU’s new MDR cybersecurity guidelines expand on the MDR and fit into the myriad other software-related guidance documents the medtech industry has to consider?
Switzerland’s current economic and trading relationship with the UK is based on its MRA with the EU. So, where does this leave the two countries in trading with one another now each of their relationships with the EU are under threat?
With fewer than a hundred days left before the EU Medical Device Regulations kick in, Medtech Insight’s executive editor Ashley Yeo and managing editor Amanda Maxwell discuss in this week's podcast growing concerns by medtech industry members that they may not be ready in time to comply with the regulations and may inadvertently run afoul of them.
What will the fall-out of political tensions between the EU and Switzerland mean for notified bodies based in Switzerland, and for the future recognition of CE marks granted in one of the most important medtech markets in Europe?
Eighteen years of free trade threatens to come to a sudden stop, as a result of the stalemate in the market access agreement between Switzerland and the EU. Industry association Swiss Medtech is advising local medtech manufacturers to find notified bodies and authorized representatives based in the EU. However, local company SQS remains confident of its ongoing notified body role.
The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.