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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

Résultats

On-Demand Webinars | Medical Device Registration in worldwide countries

New to our On-Demand webinar series: Canada. Watch our On-Demand webinars to learn more about the regulatory framework in Asia-Pacific, Latin American countries and Canada, presented by our regulatory affairs associates around the world.

ANVISA Argentine Brésil Canada Chine Colombie Global Registration Inde Malaisie Market Access China Medical Device Registration Réglementations des dispositifs médicaux Mexique Nouvelle-Zélande NMPA On-Demand Webinar Affaires réglementaires Singapour

Garantir l'intégrité des données dans les soumissions de dispositifs médicaux : Appel à l'action de la FDA

FDA Réglementations des dispositifs médicaux Dispositifs médicaux

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

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