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…

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…

Whenever you see a successful business, someone once made a courageous decision.

The above is a quote from Peter Drucker (1909 - 2005) the founding…

Why having a second supplier could make sense even if it costs more.

Having dual sourcing of important components causes additional…

IVDR Application Process – What do you need to know?

QAdvis have invited Charlotte Hess from BSI to give us some …

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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