MEDDEV

A guy showing his hand with some kind of stain on it, a smartphone showing a checkmark. All together symbolizing mole assessment via medical app as an example for risk classification . A guy showing his hand with some kind of stain on it, a smartphone showing a checkmark. All together symbolizing mole assessment via medical app as an example for risk classification .
Medical Software - Updated: 2021/04/16 - Isabel Jakobs and  Ulrich Spiegel

Risk Classification of a Medical App

Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!

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.

Monitor showing an ECG heartbeat line, a x-ray image of a hand and a graph, symbolizing medical stand alone software or Software as Medical Device (SaMD). Monitor showing an ECG heartbeat line, a x-ray image of a hand and a graph, symbolizing medical stand alone software or Software as Medical Device (SaMD).

Stand-Alone Software as Medical Device

Thorough analysis of the intended purpose provides essential evidence for stand-alone software being a medical device on its own.

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.