NMI – It’s a Swedish thing
National Medical Information Systems – NMI – are information systems that are not medical devices ...
FDA´s QMSR: ISO 13485:2016 and beyond
In our previous article we described FDAs effort to align the Quality System Regulation with the ...
Swedish Medtech Summit 2023
QAdvis är så klart representerade på höstens Swedish Medtech Summit den 21 november i Stockholm. ...
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 ...
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 ...
Medicinteknikdagarna 2023
Upplever du att de medicintekniska regelverken är lite krångliga och ibland svåra att navigera i, ...
Do you remember the FDA eSubmitter?
Over the years, the FDA has had several 510(k) submission programs to make the process more ...
Do you as a medical device manufacturer consider the intended environment of use when you design alarm sounds?
Based on experience in emergency/intensive care and equally within the medical device industry, we ...
Advancing clinical research together
Scandinavian CRO (SCRO) and Cardialysis are contract research organizations (CROs) in the field of ...