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.
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 […]
FDA issues a new version of ISO 10993-1 guidance, which impact devices with intact skin contact
In September 2023, FDA released a new version of their guidance “Use of International Standard ISO 10993-1”. In this version FDA guidance document , it is stated that: FDA agrees with the ISO 10993-1:2018 revision regarding focus on minimizing the “number and exposure of test animals by giving preference to in vitro models and to […]