December 05, 2022
A Personal Reflection as a Working Group Member on CLSI IVD Guidance Documents
Over the past eight years, Principal Consultant Diane M. Ward has been active on two working committees involved with updating EP12 and EP17 (Limit of Detection) - learn more about her experience as a working group member in this blog. 
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Your 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