Entries by Johnnie Dahlberg

October has been a busy month for us here at QAdvis

This week, Robert Ginsberg, QAdvis’s Chairman of the Board, was speaking at RMD in Brussels, our consultants have been participating as speakers at several events, including SARQA´s autumn meeting and MEDEA autumn meeting as well as participating in a meeting with Läkemedelsverket (Swedish Medical Products Agency).   We have also hosted our new 2-day course […]

Finally released – Guideline for medical device SW i EU

We think that many of you have waited for the guideline for medical device SW in EU! “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR” – Direct download link Link to European Commision A short introduction – 191014 Intro to the MDR & IVDR […]