Medical Software

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 shild with an eye on it, symbolizing GDPR principles A shild with an eye on it, symbolizing GDPR principles

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.

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

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.

Sheet of paper with a magnifying glass, showing a scale in the glass. It symbolizes the conformity with the law in harmonized standards Sheet of paper with a magnifying glass, showing a scale in the glass. It symbolizes the conformity with the law in harmonized standards
2019/01/07 - Medical Software - Updated: 2019/11/28 - Thorsten Prinz

Harmonized Standards for Medical Software

Harmonized standards are the first choice to achieve conformity with the EU MDR, but not all requirements are always covered.

Compass and a person working an computer, symbolizing Guidance for Medical Software Compass and a person working an computer, symbolizing Guidance for Medical Software

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.