Entries by Johnnie Dahlberg

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 […]

Swedish Medtech Summit 2023

QAdvis är så klart representerade på höstens Swedish Medtech Summit den 21 november i Stockholm. Kom och prata med våra konsulter Ladan Amiri och Krishnadev Moothandassery Ramdevan. Konferensen kommer ge en belysning av hur vården– och omsorgen håller på att utvecklas och hur stor betydelse de nya teknikerna kommer ha i framtiden. Som konsultföretag inom […]

Is it time to scrap the DHF, DMR and DHR?

To successfully navigate an inspection by FDA, it’s essential to maintain three separate buckets for your device files: the Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR). However, with the upcoming update to the US Quality System Regulation, these terms may no longer be used. Since 2018, the […]