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.
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 […]
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 some type of human error. We are all aware of this and more or less accept this risk when we sit down behind the wheel. So why is it such a big issue when a single […]
Holiday greetings
Soon 2023 comes to an end and we at QAdvis want to take the opportunity to thank all our clients, partners, and colleagues for the valued cooperation we have experienced throughout the year. It has been an intensive period filled with challenges, significant opportunities, valuable collaboration, and a multitude of enjoyable assignments. Looking ahead to […]
NMI – It’s a Swedish thing
National Medical Information Systems – NMI – are information systems that are not medical devices in themselves, and therefore regulated by the provision HSLF-FS 2022:42. The provision is a standalone regulation, however very similar to MDR Annex I. Since 2014, software systems in Sweden that are used on a national and regional level for handling […]
FDA´s QMSR: ISO 13485:2016 and beyond
In our previous article we described FDAs effort to align the Quality System Regulation with the global Quality Management System standard ISO 13485:2016. Although this is still a proposal, it is planned to be a Final Rule in December 2023, with implementation 2024. Even though ISO 13485:2016 will largely replace a lot of the requirements […]