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

Overview of the related regulatory requirements, Safety concepts, Testing requirements, Labelling requirements, Related Usability and Home healthcare requirements

Get an overview of the most important elements of a clinical evaluation of medical devices according to the EU Medical Device Regulation (MDR).

In this article we discuss how Usability Engineering based on IEC 62366 leads to a better and compliant medical device.

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

The risks of a medical device must be acceptable in comparison to its benefits. Manufacturers must therefore carry out a risk management process. Read how this works in this article.

The MeSo expert community will meet on 13 May 2020 in Frankfurt. Find out which regulatory requirements you have to meet now and in the future and how to implement them efficiently.

VDE MeSo offers practical support for the approval and certification of medical devices and software. We help you to bring your product to market faster and more efficiently.

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