News from QAdvis

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 could hopefully become a global standard. It will apply to any business operating within the EU or offering AI systems or services to EU residents. The use of artificial intelligence in the EU will be regulated by the AI […]

It will happen to you too.

Maybe not today or tomorrow, but it will happen, an unannounced audit from your Notified Body. Unannounced audits by the Notified Body (NB) are performed without any prior notice or schedule. The auditor can show up at any time and expect to have access to your premises and documentation related to your medical devices, including […]

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 is a very counterproductive way of looking at it. We see the QMS more like the barrier between the opposite lanes of the motorway preventing you from a head on collision in case of an innocent mistake. Sweden is […]

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 Device Regulation (MDR) before 26th of May 2024. Many medical device manufacturers, obliged to have a Notify Body acceptance and supervision, are still in the process of transfer from MDD to MDR and intend to use the […]

Our team is growing.

We start 2024 with a warm welcome to our new team-members, Ekaterina Riabova and Lee Ambolt to our office in Lund. QAdvis is happy to welcome Ekaterina and Lee to our growing team of experienced quality and regulatory consultants. This strategic expansion is a testament to our commitment to continuous growth and to be able […]