Your global regulatory partner for Medical Devices and in
Vitro Diagnostic Devices
Amstermed as an optimized Authorized Representative, serves as a global regulatory partner for Medical Devices & In vitro Diagnostic Devices. We serve as a legal entity representing the product manufacturer and acting as a liaison between the Manufacturers and relevant authority in European Union, United Kingdom, Australia, Switzerland and The United States of America by completing documentation review, product registration and legal representation.
We provide a comprehensive suite of services, including meticulous documentation review, streamlined product registration, and expert legal representation. As an authorized representative, Amstermed guarantees compliance with regulatory requirements. Our strategically located offices in Europe, Australia, the United Kingdom, Switzerland, and the United States of America further enhance our ability to offer efficient and effective support across diverse regulatory landscapes. Count on Amstermed to navigate the complexities of global regulations and facilitate a smooth market entry for your medical devices.
Amstermed provides Authorised Representative services
to our manufacturers to act on their behalf regarding
specific regulatory requirements in EU, UK, Switzerland,
Australia & US Market.
Our Vision
"To be the global leaders in medical device representation, providing
proactive and seamless services that empower manufacturers to
revolutionize healthcare."
Our Mission
"To help clients navigate the complex regulatory landscape of
medical device markets around the world, providing exceptional
representation services."
Experience
Trust
Professionalism
Diligence
M Vermin
Co-Founder
Ceo@amstermed.nl
Natalie McRoberts
Regulatory head UK and Switzerland
natalie@amstermed.nl
Poornima
Raghunandan
Regulatory Manager- EU, US
and Australia
poornima@amstermed.nl
Arab Health provides a platform to address and outline global healthcare challenges while providing attendees with opportunities to network with industry leaders from around the world.
Arab Health
MDCG 2022-16 - Guidance on Authorised Representatives Regulation (EU)
2017/745 and Regulation (EU) 2017/746 - October 2022