Amanda Maxwell
Managing Editor
Amanda is EU medtech regulatory affairs editor at Medtech Insight. She has been reporting and providing analysis on developments in the field of medical technology regulatory affairs, with particular focus on the current and future EU regulations for medical devices, IVDs and device/drug combination products since the mid-1980s. She monitors and reports on all aspects of the implementation of the EU’s Medical Device and IVD Regulations, including relevant guidances, standards, expert opinions and ongoing challenges for all players in meeting the new requirements.
Her features have appeared in a variety of in-house publications and services. She also wrote medtech regulatory country profiles for Citeline’s former EU Law service and regularly contributes to In Vivo. Amanda regularly interviews experts in the EU medtech regulatory space and publishes interview podcasts. She also has experience in providing medtech regulatory strategy consultancy services, is often invited to speak and chair at EU meetings on medtech regulations and drug/device combination regulatory issues and is a frequent advisor to conference organizations.
Amanda enjoys taking part in LinkedIn discussions, has a background in the language and literature of Italy and France, and a passion for being part of the EU scene.
Latest From Amanda Maxwell
Mid-May MDCG Mandate Madness: Pre-empting Questions On Investigator Brochures
Newly issued EU guidance documents make it easier for device companies to draft clinical investigation brochures that will pass authority inspection. They also give insight into what notified body designating authorities check for.
BSI First Notified Body To Officially Publish Lead Times Under EU Medtech Regulations
BSI says it has no capacity restrictions under the Medical Device Regulation or the IVD Regulation and can start the technical documentation review for the majority of product categories within a month from submission.
EU Medical Professions Call For Immediate Measures To Prevent Device Shortages
Their concerns overlap with those of the medtech products industry when it comes to how patients will be impacted unless critical action is taken to improve the EU's Medical Device Regulation.
EU Announces Fifth MDR Notified Body Designation In Five Weeks
The latest EU organization to be named under the Medical Device Regulation is based in Austria.
Notified Body Numbers Continue To Shoot Upwards As Turkey Gains Third Certification Body
The designations of notified bodies are coming fast and furious, with four announcements in a month.
Latest Designation Of Italian Notified Body Brings EU Total Under Medical Device Regulation To 47
EU announces the third designation under the MDR in a month.