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Faits marquants

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

juillet 17, 2025

Comment fonctionne la collaboration avec un partenaire consultant en matière de conseil réglementaire ?

La réalisation d'une diligence raisonnable à la fois approfondie et efficace représente des défis complexes en matière d'investissements dans les technologies médicales qui exigent des approches spécialisées.

Blog Due Diligence

juillet 10, 2025

Due diligence réglementaire pour les acquisitions MedTech

La due diligence réglementaire est devenue cruciale dans le cadre les fusions et acquisitions dans le domaine des MedTech.

Blog Due Diligence

juillet 09, 2025

Things you need to know about market access in Singapore

In Singapore, the Health Sciences Agency (HSA) regulates the import, manufacturing, export and supply of medical devices to safeguard public health safety.

Global Registration Legal representation Singapour

juillet 03, 2025

The impact of regulatory changes on the value of MedTech businesses

The MedTech sector faces unprecedented regulatory overhaul, particularly with Europe's transition from the Medical Device Directive (MDD) and In Vitro Diagnostic Directive (IVDD) to the more stringent Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

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.

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