Clinical Affairs

2020/12/08 - Clinical Affairs - Cord Schloetelburg

Clinical Evaluation of Medical Devices according to MDR

Manufacturers of medical devices must carry out a clinical evaluation of their products in order to be allowed to market them in Europe. To do this, the manufacturer must use clinical data to check whether the medical device is safe and efficient.

2019/01/11 - Clinical Affairs - Updated: 2021/04/16 - 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 A hospital in the background, a patient and a medicin in the foreground and a big datasheet, symbolizing Medical Device Clinical Trials
2019/01/04 - Clinical Affairs - Updated: 2021/04/16 - 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.