QAdvis News #4 – 2022
Eighteen months have passed since the application date of the medical device regulation in May ...
Author Aurevia:
Proposed changes of MDR transition times
EU Commission is proposing elements of a bridging measure for MDD certificates that expire pending ...
Life Science barometer 2022
SwedenBIO’s Life Science Barometer highlights industry trends, as well as critical needs within the ...
EU Medical Device Regulation for combination products
Do you work with at the crossroads of medtech and pharma developing combination products? Are you a ...
United to accelerate innovation in clinical research
Sweden and the Netherlands, represented by Scandinavian CRO (SCRO) and Cardialysis, are uniting in ...
Welcome Noomi
We are very pleased to announce the joining of our new colleague Noomi Altgärde and extend a warm ...
2-day course EN ISO 13485:2016
The harmonised EN ISO 13485:2016 standard can be used to show compliance with the regulations and ...
Update of the guidance for medical device software applications (apps)
MHRA (Medicines and Healthcare Products Regulatory Agency) has published an update of the guidance ...
Book of the Year Award
Fantastic news! Regulatory Affairs Professional Society (RAPS) has congratulated Robert Ginsberg ...