Regulators will regulate, and AI is on top of their list.
The EU AI Act will become the world’s first broad legal framework for artificial intelligence and ...
Author Aurevia:
It will happen to you too.
Maybe not today or tomorrow, but it will happen, an unannounced audit from your Notified Body. ...
Does quality and regulatory pose a challenge to Innovation?
Quality and Regulatory Affairs is often regarded as being a hindrance to innovation. We think this ...
The 26th of May 2024 is soon here!
Ensure that your Quality Management System (QMS) is up to date and in line with the EU/EEA Medical ...
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 ...