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avril 02, 2024

The Role of Biological Risk Management in Medical Device Development

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.
mars 18, 2024

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.
mars 06, 2024

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.
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.
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).