QAdvis is now officially part of Aurevia. This change of name follows our company’s integration into Aurevia. The Aurevia brand was born in January, when Labquality, Artimed, Clinical Consulting, Kasve, and Prisma CRO merged under the same name. With QAdvis now proudly joining the team, we are further strengthening our expertise and services and together offering greater value to our joint customers. Scandinavian CRO is also joining Aurevia.
2019 was an exciting year for us at QAdvis!
Hermine Redl, Office Manager, and Bing Wu, E.A.R. Manager and Quality and Regulatory Consultant at our Kista office and Caroline Ehrenborg, Quality and Regulatory Consultant at our Lund office are all very welcome new members on our team. We have taken part in a number of conferences this year, including RMD USA, RMD Europe, RAPS USA […]
QAdvis wishes all our customers and partners a Merry Christmas and a Happy New Year!
We refrain from physical christmas gifts and choose to support the Swedish Childhood Cancer Foundation (Barncancerfonden) in their effort to prevent and combat cancer diseases in children. Read our Diploma (Swedish). Link to the Swedish Childhood Cancer Foundation (Swedish).
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. […]