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At QAdvis we understand the challenges of navigating the complex landscape of medical and invitro medical device development and market surveillance.
Risk management
Risk management has become central in the life cycle of medical devices …
Software and Cybersecurity
Throughout the software development lifecycle, collaboration between …
Marketing approval for medical devices, MD and IVD
The marketing approval process for medical devices refers to the process of …
Access UK
One of our key competences is to support non-UK manufactures of medical …
Biocompatibility assessment
Biocompatibility assessment plays a crucial role in the overall design and …
Due Diligence
Stricter regulatory requirements on medical device economical operators …
Quality Management System for medical device manufacturers
The implementation of the Medical Device Regulation (MDR 2017/745) and …
Access European Union (EU)
We also assist non-EU manufactures of medical devices to comply …
PMS – Post Market Surveillance
Post market surveillance is a crucial part of the medical device lifecycle and …
Usability
The usability of medical devices is a crucial aspect that impacts effectiveness …
Clinical evaluation and Performance evaluation
Clinical evidence is a critical component for medical device development …
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+46 8 621 01 05