Medical Software

In this article we give an overview of the software life cycle of medical devices and the corresponding standards.

Segregation is an important strategy in software development for reducing complexity. Find out how to apply segregation to your software!

Our resources of legal requirements for medical software help you to find all important laws, guidelines, and standards.

The MDR caused uncertainty concerning software classification. We give you an exclusive insight into the upcoming EU guideline!

Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!

Market access of medical software in the U.S. is quite different compared to Europe. Get insights about the principles.

Software documentation can meet regulatory requirements although it is based on an agile development process. Our video will show you how!

Thorough analysis of the intended purpose provides essential evidence for stand-alone software being a medical device on its own.