Does the requirement for an independent person at design reviews no longer apply?

The FDA’s recent implementation of the Quality Management System…

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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