New requirements on Clinical Evaluations

23.8.2017

MEDDEV guidance on Clinical Evaluations has been updated (MEDDEV 2.7.1 rev. 4). The guidance is clearly more extencive than previously, but includes also guiding how to apply it. Notified Bodies, in our experience, are getting more active on this. Read more »

New MD and IVD regulations approved

12.4.2017

The European device regulation is changing! The European Parliament has approved  the new regulation regarding medical devices and  IVD devices on May 4th 2017. As the European Council has accepted regulations earliert... Read more »

Merry Christmas and a Happy New Year!

15.12.2016

Merry Christmas and a Happy New Year! God Jul och Gott Nytt År! This year we donated the card funds to the Association of Friends of the University Children's Hospital. Detta år begåvade vi julkort pengar till Barnkliniernas... Read more »