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
Forthcoming requirements under the EU’s new Medical Device Regulation are creating upheaval for the medicinal products industry, unaccustomed to engaging with notified bodies and unfamiliar with the loose timelines that the medtech industry operates within. Will an increase in joint working, joint documents and general crossover between the drug and device sectors smooth the way?
With the delivery of drugs via medical devices commonplace now, and the introduction of new EU rules for these products via the MDR, the pharma industry is also searching for notified body capacity. It is dismayed at the uncertainty ahead.
Like every other service supporting compliance with the EU MDR, pre-clinical testing services are feeling the strain. Sandi Schaible explains why the demand is so high, and what manufacturers should know to ensure timely compliance.
There has been much excitement on social media as the designation of DEKRA as the EU’s first IVD notified body under the new IVD Regulation becomes public.
The fast and furious pace of EU medtech regulatory activity continues. Here we summarize six documents that have recently appeared on the European Commission’s medtech website.
As the European Commission invites candidates to join its medtech expert panels, it is becoming apparent just how significant a cornerstone of MDR implementation they will be. Will it take long to find the experts?