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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

Latest News, Articles and Seminars

Compliance with ISO 13485 and EU MDR/IVDR require clear evidence…
Human Factors Engineering (HFE) or Usability Engineering (UE)…
International Congress on Quality in Laboratory Medicine and…
The EU Commission is urged to propose solutions by no later…
QAdvis continue the collaboration with Labquality and will…
People often talk about the Post Market Surveillance (PMS)…

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

+46 8 621 01 05