Amanda Maxwell
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.
Latest From Amanda Maxwell
How Europe’s Nomenclature System Works And Offers New Insights
Transparency linked to new device registration rules will provide new market analysis possibilities. Medtech Insight delved deeper into the benefits of the European Medical Device Nomenclature with two Italian executives who see its potential.
Reading Between The Lines: Is There A Positive Message Hidden In MDCG’s Blame Document?
The hope is now that a new EU document will be issued to address head on the scale of bottlenecks at notified bodies and of products needing to be removed from the market.
Commission Offers Glimpse Of Actions To Speed Up MDR Compliance
With a sense of desperation building among stakeholders over the challenges in ensuring all products are compliant with the Medical Device Regulation in time, high-level solutions are being considered. But a further MDR delay is not an option.
MDCG Throws Ball Back Firmly In Manufacturers' Court As Pressure Grows For MDR Solutions
EU manufacturers who delay applying to notified bodies for conformity assessment of their medtech products well in advance are being held accountable for implementation problems with the EU Medical Device Regulation.
New Voices Clamor For Urgent MDR Action To Avoid Major Clinical Crisis
Industry and notified bodies have long warned of the hurdles to implementation of the Medical Device Regulation. Now competent authorities and medical and research societies are adding to the pressure for the EU to find solutions fast.
EU Offers Insight On New MDR Guidance Documents On The Horizon
The EU Medical Device Regulation has been in force for a year and the IVD Regulation applied a few weeks ago. Many vital guidance documents have been in the pipeline for considerable time but will be made available later this year.