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 race is on for companies to be among the first to CE mark their devices under the new EU regulations. Much will depend on which notified bodies are designated first; and national competent authorities play a key role.
As the date that EU notified bodies can submit for designation under the new regulations rapidly approaches, can EU designating authorities audit notified bodies against the MDR and IVDR at the same time to improve efficiency? And can notified bodies audit against the legacy directives alongside the regulations to minimize worst-case logjams?
As medtech grapples with the overwhelmingly complex implementation of the EU's new Medical Device and IVD REgulations, one legal pioneer, Oxford's Christopher Hodges, says it's time to think differently.
It is nearly six months since the EU's Medical Device and IVD Regulations entered into force. In 10 days' time, on Nov. 26, notified bodies can apply to be designated under the new rules. More are ready than expected. Can the European Commission cope?
The EU Roadmap has been published. But it represents a dawning of a hard truth. The EU medtech sector still has a long way to go along the road to implementation before it gets the clarity it needs.
More and more details are emerging about the likely impact of Brexit, as MedTech Europe shows in its newly publicized position paper. Will some companies even come to regret hiring UK notified bodies?