Entries by Johnnie Dahlberg

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 […]

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 place in Brussels on 26-27 February 2024. It is the 8th consecutive year with seasoned speakers from the medical device industry, including EU Commission, competent authority and notified bodies. It is a fantastic prestigious 2-day event, this year held at […]

AI systems: The Benefit / Risk balance

Autonomous cars and medical devices are only two examples of autonomous systems, which are systems that can achieve a specified goal, independent of detailed programming. These systems have both risks and advantages that need to be considered by manufacturers, users and regulators alike. Autonomous systems can increase efficiency and productivity by reducing costs, saving time […]