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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
Structural Heart Interventions. In Pursuit of the Holy Grail?
Transcatheter Aortic Valve Implantation/Replacement Structural heart disease minimally invasive interventions represent a new branch of
Do You Need a Transition Strategy from MDD to MDR?
If you are failing to plan, you are planning to fail. It is crucial for all medical device manufacturers, as part of their business strategy,
EU MDR Gap Analysis | Are You Prepared For Changes?
In the past, due to the relative requirements and processes in place in each area, it has been the conception that it is better for products to enter
Are you ready for MDD to MDR transition?
The MDR will replace the existing Medical Devices Directive (93/42/EEC) [MDD] and the Active Implantable Medical Devices Directive (90/385/EEC)
ISO 14155 Standard vs. FDA Medical Device Regulations
Background The ISO 14155 standards were created to clarify the design, conduct, recording and reporting of clinical investigations carried out in
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