EU MDR

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!

A shield in with a lock on it in the foreground, 0 and 1 in the background, symbolizing cybersecurity principles in software A shield in with a lock on it in the foreground, 0 and 1 in the background, symbolizing cybersecurity principles in software
2019/02/05 - Cybersecurity - Updated: 2020/06/05 - Thorsten Prinz and Daniel Jacobi

Cyber Security Threats in Healthcare

Cyber security threats affect medical device safety and patient protection. Learn here how to perform best regarding risk management.

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).
2019/01/10 - Medical Software - Thorsten Prinz and Isabel Jakobs

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
2019/01/10 - Medical Software - Thorsten Prinz and Isabel Jakobs

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.

2019/01/08 - Regulatory Affairs - Cord Schloetelburg

EU MDR Factsheet for Manufacturers of Medical Devices

Medical device manufacturers must implement the new EU MDR. Here you will find an overview to get things going.

footsteps towards a sign saying ce, symbolizing step by step guide to EU CE medical device certification footsteps towards a sign saying ce, symbolizing step by step guide to EU CE medical device certification
2019/01/03 - Regulatory Affairs - Cord Schloetelburg

Medical Device Certification Based on the New EU MDR: a Step by Step Guide

Medical device certification is a prerequisite for market access in Europe. Use this checklist to start certification based on the new EU MDR.

Compass and a person working an computer, symbolizing Guidance for Medical Software Compass and a person working an computer, symbolizing Guidance for Medical Software
2019/01/03 - Medical Software - Thorsten Prinz

Guidance for Medical Software Companies

You have to do with medical software and feel lost in regulation? Don’t give up. Get guidance with our latest book.