embedded software

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).
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.

Person with a broken leg and a broken arm, money flying around him, symbolizing product liability with medical devices Person with a broken leg and a broken arm, money flying around him, symbolizing product liability with medical devices
2019/01/09 - Medical Software - Cord Schloetelburg and Boris Handorn

Product Liability and Medical Software: Fortunately You Can Insure Yourself

Software can be a medical device. This has considerable consequences for product liability. The good news: manufacturers can manage the risks.