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…

We are delighted and proud to announce that QAdvis Group has achieved ISO 13485:2016 certification. This is a major milestone … Read more here!

At the core of every design and development process are the user needs. Too often, however, the user needs are limited to … Read more here!

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