Johnnie Dahlberg | QAdvis AB

About Johnnie Dahlberg

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Entries by Johnnie Dahlberg

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 […]