Does the Health Technology Assessment Regulation (HTAR) include medical devices?
The Health Technology Assessment Regulation (HTAR), officially known as Regulation (EU) 2021/2282, ...
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Regulatory strategy vs. regulatory intelligence
Navigating the regulatory landscape of the medical device sector is a complex task, requiring both ...
Can regulatory strategy and regulatory intelligence replace each other or do you need both to ensure market access and fulfilment of post market obligations
Navigating the regulatory landscape of the medical device sector is a complex task, requiring both ...
SCRO is now Aurevia
We are happy to announce that Scandinavian CRO (SCRO) is now operating under the name of Aurevia, ...
QAdvis is now Aurevia – Expanding our capabilities together
QAdvis is now Aurevia – expanding our capabilities together We are happy to announce that QAdvis is ...
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According to MDR 2017/745 “Devices shall be designed and manufactured in such a way as to ensure ...
Merging expertise: Clinical research and regulatory affairs
In January, Aurevia was established from the merger of five European companies within clinical ...
Ulrika Hammarström appointed new Head of CRO
Last year, Aurevia (formerly LabQuality) acquired Scandinavian CRO. Recently, Ulrika Hammarström, ...
The FDA is being restructured and the world is holding its breath
For nearly 30 years, the U.S. Food and Drug Administration has played a pivotal role in shaping the ...