QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
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 […]
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 […]