Next upcoming event …

2-day course Medical device software process design
based on IEC 62304

The course is focused on how to develop medical device software and maintaining it according to
the requirements of the IEC 62304 standard and regulatory requirements for medical device software.

More information and registration!
Stockholm 26th and 27th March 2019 (seats left)

Medical Devices Regulation Countdown

(EU) 2017/745 (MDR)


All medical devices need to comply with a number of rigidly specific requirements from national regulatory bodies.  Read more.

As medical device companies grow, significantly change their organization or evolve into several sites, the need often … Read more.

We know, from extensive experience, that compliance goes hand in hand with productivity. Don’t fall into the trap of … Read more.

Our team of senior software consultants can assist you in achieving compliance and high productivity in your software … Read more.

Non-European manufacturers of medical devices without an establishment within the European Union are required … Read more.