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 […]

The 4th EAAR Annual Conference on New Medical Device Regulations

Robert Ginsberg, Chairman of the board at QAdvis and board member of European Association of Authorized Representatives (EAAR), is one of the speakers at RMD 2019. The event takes place in Brussels on 28–29 October, 2019, with an impressive list of competent speakers, including industry experts, and speakers representing EU Com, Notified Bodies, Legal and MedTech Europe. […]