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Le Rôle de la Gestion des Risques Biologiques dans le Développement des Dispositifs Médicaux

The biological evaluation of medical devices, guided by ISO standards, must be integrated into the risk management process to ensure comprehensive consideration of biological risks, a task often challenging for manufacturers but addressed by Qserve through expert collaboration, structured assessment, and data integration for enhanced safety evaluation and testing.

Biocompatibilité Réglementations des dispositifs médicaux Dispositifs médicaux Gestion des Risques

janvier 24, 2024

FDA Proposal to Change the Classification of Certain Wound Dressings, Topicals and Liquids

Blog FDA Dispositifs médicaux

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Le Rôle de la Gestion des Risques Biologiques dans le Développement des Dispositifs Médicaux

The biological evaluation of medical devices, guided by ISO standards, must be integrated into the risk management process to ensure comprehensive consideration of biological risks, a task often challenging for manufacturers but addressed by Qserve through expert collaboration, structured assessment, and data integration for enhanced safety evaluation and testing.

Biocompatibilité Réglementations des dispositifs médicaux Dispositifs médicaux Gestion des Risques

Q&A: Chinese Medical Device Regulations NMPA

The most common questions and answers about market access in China. In this whitepaper 21 questions will be answered about the Chinese Medical Device Regulations NMPA. Everything you need to know about Medical Device Registration in China.

Chine China Agent Global Registration Market Access China Medical Device Registration NMPA Highlights

Countdown to Compliance: Safeguarding Your EU Market Access in Less Than 100 Days – Stay on Track!

As the May 26, 2024, deadline for EU MDR transition approaches, regulatory compliance becomes paramount.

Réglementations des dispositifs médicaux Dispositifs médicaux Highlights

février 26, 2024

L'Union européenne continue-t-elle de favoriser l'innovation et se préoccupe-t-elle des PMEs ?

This blog discusses various topics related to medical device innovation, including challenges faced by startups, regulatory complexities, the impact of AI-enabled devices, the need for material innovation, and the importance of thorough clinical data collection for safety and compliance, emphasizing an integral approach to regulatory strategy and collaboration between companies and CROs.

Réglementations des dispositifs médicaux Dispositifs médicaux Affaires réglementaires

février 16, 2024

Certification news | Regulatory Compliance Certification IVDR for Christie Hughes

Congrats to Christie Hughes, MPH, MLS(ASCP), RCC-IVDR, for achieving Regulatory Compliance Certification IVDR (RCC-IVDR) at Regulatory Affairs Professionals Society (RAPS).

CE Certification Clinical Investigation Europe In-Vitro Diagnostics IVDR Regulatory Compliance Technical Documentation

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