Our team is growing.
We start 2024 with a warm welcome to our new team-members, Ekaterina Riabova and Lee Ambolt to our ...
The 8th EAAR Annual Conference on the New Medical Device Regulations
The EAAR Annual Conference on the New Medical Device Regulations (RMD2024) will this year take ...
AI systems: The Benefit / Risk balance
Autonomous cars and medical devices are only two examples of autonomous systems, which are systems ...
The MedTech and Automotive Industry have a lot in common when it comes to AI.
In Sweden alone over 200 people are killed yearly in road accidents. A majority of those are due to ...
NMI – It’s a Swedish thing
National Medical Information Systems – NMI – are information systems that are not medical devices ...
FDA´s QMSR: ISO 13485:2016 and beyond
In our previous article we described FDAs effort to align the Quality System Regulation with the ...
Swedish Medtech Summit 2023
QAdvis är så klart representerade på höstens Swedish Medtech Summit den 21 november i Stockholm. ...
Is it time to scrap the DHF, DMR and DHR?
To successfully navigate an inspection by FDA, it’s essential to maintain three separate buckets ...
FDA issues a new version of ISO 10993-1 guidance, which impact devices with intact skin contact
In September 2023, FDA released a new version of their guidance “Use of International Standard ISO ...