FDA´s QMSR: ISO 13485:2016 and beyond

In our previous article we described FDAs effort to align the…
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Swedish Medtech Summit 2023

QAdvis är så klart representerade på höstens Swedish Medtech…
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Is it time to scrap the DHF, DMR and DHR?

To successfully navigate an inspection by FDA, it’s essential…
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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…
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Medicinteknikdagarna 2023

Upplever du att de medicintekniska regelverken är lite krångliga…
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Do you remember the FDA eSubmitter?

Over the years, the FDA has had several 510(k) submission programs…
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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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