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Faits marquants

juillet 04, 2024

As Europe moves into the summer…

This week parts of Europe saw the first nice, warm and sunny days of the year, as it has been an exceptionally wet and rainy year so far. Let’s hope that the same transition is ahead of us in the medical device and IVD regulatory space!

IVDR MDR 2017/745

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

juillet 16, 2024

Understanding the MDCG 2024-10 Guidance: Will it really help patients that need orphan medical devices?

juillet 16, 2024

Key Amendments to MDR and IVDR: EUDAMED Implementation and Compliance Guidelines

In this blog we'll discuss the gradual EUDAMED implementation, with a focus on compliance and transition requirements for manufacturers.

EUDAMED In-Vitro Diagnostics Réglementations des dispositifs médicaux Dispositifs médicaux

juillet 15, 2024

New Updates to IVD Classification Guidance Document MDCG 2020-16 r3 - Clarify Guidance for Self-Testing and Specimen Receptacle Devices

On 8 July 2024, the European Commission released the third revision of MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices, adding a definition for ‘kit’ and clarifying classification rules for self-testing and specimen receptacle devices.

Classification Rules In-Vitro Diagnostics MDCG

juillet 12, 2024

Navigating the New Era: The AI Act and Its Impact on Medical Device Manufacturers

AI In-Vitro Diagnostics Réglementations des dispositifs médicaux Dispositifs médicaux AI Act

juillet 12, 2024

Presentation Download | Impact of the EU AI Act on Medical Device and IVD Manufacturers

AI Artificial Intelligence

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