EU Commission working on a proposal to postpone the new Medical Device Regulation for one year
Today (25 March 2020), the Commission announced that they are working to submit this proposal in ...
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Covid-19 situation statement
In the current situation with Covid-19, increasingly stricter national measures are being ...
Good study practice for IVDs - ISO 20916
ISO 20916 is a new ISO for clinical performance studies with in vitro diagnostic (IVD) medical ...
QAdvis News #1 – 2020
Focus on risk management and auditing Without doubt, the new medical device regulations add an ...
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 ...
QAdvis wishes our customers & partners a Merry Christmas and Happy New Year!
We refrain from physical christmas gifts and choose to support the Swedish Childhood Cancer ...
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 ...
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 ...
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 ...