Your Global MedTech Partner for Regulatory Affairs, Quality Assurance 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 multifaceted team ranging from junior to principal consultants and depending on your project, we can form a cost-effective team and strategy
  • We charge you for the work performed, no hidden costs
  • We train and we leave something behind, a regulatory compliance imprint
  • One 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