medical app

A hand with a red hose leading to a blood icon, a hand with a smart phone and a diagram and a certificate saying "compliance". Symbolizing MDR compliance for medical apps. A hand with a red hose leading to a blood icon, a hand with a smart phone and a diagram and a certificate saying "compliance". Symbolizing MDR compliance for medical apps.

[Video] How to Achieve MDR Compliance for Medical Apps

It’s hard to achieve MDR compliance when developing medical apps. Learn in this presentation how to overcome this hurdle.

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!

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.