Articles – Resources – AKRN Social network
List of Member States’ Competent Authorities for Medical Devices
The competent authorities are responsible for transposing the requirements of European regulations into national legislation. The competent
What is the status of the COVID-19 rapid tests in the EU/EEA?
In-vitro diagnostic tests for detecting the coronavirus is an essential tool in slowing the
Humanitarian Exemption and Emergency Approval Scenarios
United States - European Union Exceptional regulatory situations have been allowed recently due to the coronavirus pandemic. Exceptional
List of Notified Bodies under MDR (EU) 2017/745 on Medical Devices
A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market. The conformity
Free Resources for the Medical Device Industry to Fight COVID-19
Do you want to place your medical device or in-vitro diagnostic device on the market, but you have limited resources to do so? We prepared this
ÅKRN is Joining The Fight Against COVID-19
ÅKRN is a European Medical Device and In-Vitro Diagnostics CRO that can help your company get clinical trial approval / EU market approval To
The Path to CE-mark
There’s a common misconception among many medical device manufacturers that obtaining a CE mark is now too hard, too costly, and too
For Medical Device Start-Ups: A Brief Guide To CE Mark Certification
It is understandable that many medical device start-up companies have limited resources and they do not have time to study the new EU MDR
What You Need to Know About the New ISO 14155 Standard
New requirements and changes in the standard of references for Medical Device Clinical Investigations. The third edition of the standard is under
AKRN Social Network