Can supply problems potentially result in shortages of medical devices in hospitals?
In recent years, significant disruptions in global supply chains…
Join us at the Swedish Medtech Regulatory Summit on 14 March 2024
QAdvis will attend the yearly Regulatory Summit hosted by Swedish…
Regulators will regulate, and AI is on top of their list.
The EU AI Act will become the world's first broad legal framework…
It will happen to you too.
Maybe not today or tomorrow, but it will happen, an unannounced…
Does quality and regulatory pose a challenge to Innovation?
Quality and Regulatory Affairs is often regarded as being a hindrance…
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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QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.