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.
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Amanda Maxwell
Will there be enough resources for IVD manufacturers to be audited in time against the EU's IVD Regulation? A survey from TEAM-NB reveals a drop in notified body numbers just at a time when more resources are needed.
Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations
Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified bodies are the biggest barrier to products being able to comply with the new EU Medical Device Regulation before deadlines. Time is running out.
The recent no-deal Brexit notice from the UK government says that companies selling devices in the UK would need a "Responsible Person" in the UK if the firm is not based there. The government clarifies to Medtech Insight that such person must be physically present in the UK, and not simply have an address there.
EU Regulatory Roundup, 2018: Year Of Dithering And Distractions Likely To Be Topped By Upcoming Year Of Turbulence And Stress
2018 needed to be medtech's year to focus on the ongoing implementation of the EU MDR and the IVDR and the structures and documents to support them. But lack of progress means a 2019 work bulge amid Brexit issues and recent journalistic investigations. Here's a look at the top EU regulation issues and articles of the past year.
With the UK still wallowing in uncertainty over Brexit, the government has been forced hit the ground running in January by issuing various documents spelling out in greater detail what will need to happen in the case of a "no-deal" Brexit, which is looking increasingly possible. What does medtech need to know?
EU Regulatory Roundup, December 2018: Renewed Focus On Regs While 'Implant Files' Still Grabs Attention
Passing the half-way mark in the transition period to full implementation of the EU's new Medical Device Regulation (MDR) seems to have focused the attention of readers back onto technical regulatory issues.