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

Safety risks have always been considered in risk management according to ISO 14971. But what is about upcoming security risks?

In May 2019 the medical software community came together at the VDE Medical Software Event. Save the date: May 13, 2020.

Traceability plays a key role in increasing the safety of medical devices. Now, Unique Device Identification (UDI) also applies in Europe.

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.

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

The EU MDR contains new rules for medical device risk classification. Stand-alone medical software usually ends up in higher classes.

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