MEDDEV

Medical Software - Updated: 2020/05/29 - Thorsten Prinz

Legal Requirements for Medical Software

Our resources of legal requirements for medical software help you to find all important laws, guidelines, and standards.

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: 2020/01/06 - 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: 2019/11/28 - 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.

Tree Model for Classification Tree Model for Classification

Medical Device Classification: The Software Special

The EU MDR contains new rules for medical device risk classification. Stand-alone medical software usually ends up in higher classes.

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: 2019/11/28 - 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.