April 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.
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Your MedTech Partner for Regulatory, Quality Affairs and Clinical Trials

Qserve is the largest consultant company in the EU that is 100% focused on medical devices and In-Vitro Diagnostics. Check out our company video.

Why choose Qserve as your regulatory consultant?

 

  • We know exactly what should be prepared to become and stay in compliance with the regulations
  • Strong international team with technical, regulatory quality and clinical competence
  • Ex EU Notified Body, FDA, and CFDA staff
  • Full Medical Device CRO services
  • We have a team where we use multiple levels, from junior to principal. Depending on your project we are able to form a cost-effective team
  • We charge you for the work performed, no hidden costs
  • We train and we leave something behind, a regulatory compliance imprint
  • 1 contact point giving you access to a broad team with all expertise
  • Legal representation in China, Europe and the United States

 

Our method

"Our mission is to support all medical device and IVD manufacturers with a practical approach, translating existing regulations to understandable requirements."
Jan van Lochem , CEO