Clinical Affairs - by Cord Schloetelburg

Clinical Evaluation of Medical Devices

Get an overview of the most important elements of a clinical evaluation of medical devices according to the EU Medical Device Regulation (MDR).

Published: 2019/01/11 - Clinical Affairs - Updated: 2019/11/28 - by Thorsten Prinz and Helene Kern

How to Perform Clinical Evaluation of Medical Software

Manufacturers must do a clinical evaluation of a medical device before they can market it in Europe. Find out what you need to keep in mind.

A hospital in the background, a patient and a medicin in the foreground and a big datasheet, symbolizing Medical Device Clinical Trials
Published: 2019/01/04 - Clinical Affairs - Updated: 2019/11/28 - by Thorsten Prinz and Helene Kern

Medical Device Clinical Trials

Medical device clinical trials are completely new regulated under the EU MDR. Manufacturers are faced with new challenges.

Do you want faster market access of medical software?

Then subscribe to our newsletter and get practical insights about all relevant regulatory aspects.

In the privacy policy we describe how your personal data is processed electronically.