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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

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

PMS – Post Market Surveillance

Post market surveillance is a crucial part of the medical device lifecycle and …


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

Latest News, Articles and Seminars

In most 510(k)s the FDA does not require clinical data, and class…
Labquality strengthens its regulatory affairs service…
Let’s talk about incident reporting, one of the important Post…
Let’s talk about incident reporting, one of the important Post…
AI enabled medical devices are increasingly making their way…
There is a common misconception that only manufacturers need…

Contact us for further information or if you want to learn more about how we can support you.

Stockholm Office Färögatan 33, 164 51 Kista, Sweden.
Lund Office Scheelevägen 17, 223 70 Lund, Sweden.

+46 8 621 01 05




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