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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

EU Regulation 2024/1860 includes an amendment to the MDR &…
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We are pleased to introduce two new team members who will be…
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In most 510(k)s the FDA does not require clinical data, and class…
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Labquality strengthens its regulatory affairs service…
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Let’s talk about incident reporting, one of the important Post…
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Let’s talk about incident reporting, one of the important Post…
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Contact us for further information or
if you want to learn more about how we can support you.

+46 8 621 01 05

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