Importers and Distributors: Pivotal roles in MDR and IVDR Compliance
There is a common misconception that only manufacturers need to comply with the Medical Device ...
We strengthen our team.
A warm welcome to Marie Mathiasson, our new team-member in Kista QAdvis is happy to welcome Marie ...
Does the requirement for an independent person at design reviews no longer apply?
The FDA’s recent implementation of the Quality Management System Regulation (QMSR) introduces ...
Can supply problems potentially result in shortages of medical devices in hospitals?
In recent years, significant disruptions in global supply chains have had a huge impact on ...
Join us at the Swedish Medtech Regulatory Summit on 14 March 2024
QAdvis will attend the yearly Regulatory Summit hosted by Swedish Medtech. This year Robert ...
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 ...
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 ...