
FDA´s QMSR: ISO 13485:2016 and beyond
In our previous article we described FDAs effort to align the…

Swedish Medtech Summit 2023
QAdvis är så klart representerade på höstens Swedish Medtech…

Is it time to scrap the DHF, DMR and DHR?
To successfully navigate an inspection by FDA, it’s essential…

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…

Medicinteknikdagarna 2023
Upplever du att de medicintekniska regelverken är lite krångliga…

Do you remember the FDA eSubmitter?
Over the years, the FDA has had several 510(k) submission programs…