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février 03, 2025

Introducing Qserve Learn: A dedicated online learning platform for the Medical Device and IVD sector!

Qserve Learn is a flexible and comprehensive online training platform designed to equip clinical, regulatory, and quality professionals in the Medical Device and IVD sector with expert-led courses, virtual training, and on-demand resources to support their professional growth.

E-Learning Qserve Learn Training Virtual Training

Navigating MDR Challenges: How Qserve's Interim Support Can Optimize Your Medical Device Compliance

Explore how the European Union’s Medical Device Regulation (MDR) revolutionizes safety standards for medical devices while challenging companies' resources, and discover how interim support can be a game-changer in navigating these stringent new requirements.

Réglementations des dispositifs médicaux Dispositifs médicaux Interim Support Medical Device Compliance

Résultats

Do you need help with regulatory strategies for AI medical device?

To put your AI medical device on the market, it is important to get your strategy right. Since most markets follow either the FDA or the EU approach, we will be looking into both, highlighting similarities and differences.

Key focus areas of Medical Device AI Compliance

In this blog, we will discuss the key focus areas of Medical Device AI compliance, focusing on the FDA and European regulatory frameworks.

AI Compliance foundation for medical devices

Artificial intelligence (AI) has become integral to many medical devices in today's rapidly evolving technological landscape. However, organizations integrating AI capabilities in healthcare products often underestimate the regulatory implications, creating significant business risks.

Things you need to know about market access in the United Arab Emirates

In the United Arab Emirates (UAE), medical devices are regulated by the Ministry of Health and Prevention (MOHAP). They evaluate the safety and quality of the devices in line with international standards such as U.S. FDA and European CE.

Blog Global Registration

IVDR 3^rd Anniversary – Did you take your foot off the gas? Time to accelerate!

On 26 May 2025 we are celebrating the 3^rd anniversary of the IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices).

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