medical software

2021/05/25 - Artificial Intelligence, Cybersecurity, Medical Software - Thorsten Prinz und Hans Wenner

Next-level security for AI-based software as medical device

To prove the safety and performance of AI-based software as a medical device, there are special documentation requirements due to data management and model development.

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!

A shild with an eye on it, symbolizing GDPR principles A shild with an eye on it, symbolizing GDPR principles
2019/01/09 - Medical Software - Cord Schloetelburg and Gerald Spyra

GDPR Principles and Medical Software: Privacy by Design is King

The GDPR is legal basis for data protection in Europe. You should adopt GDPR principles directly into the design of your medical devices.