May 31, 2021
Updated IMDRF guidance on PMCF studies
On 20 May the IMDRF posted an updated guidance on Post-Market Clinical Follow-up (PMCF). Guidance IMDRF/MDCE WG/N65 FINAL:2021 updates the former GHTF document on PMCF which dates back to 2010 (GHTF/SG5/N4:2010).
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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.

 

Europe

Our knowledge of the European Medical Device Regulation (EU-MDR) ensures that we can train and support you with an efficient regulatory strategy.

 

China

We can help you navigate through the Chinese market by offering a wide range of customized services.

 

USA

We have supported hundreds of Medical device manufacturers with FDA submission. Qserve’s legal entity can act as US Agent and Official Correspondent.

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 manufacturers with a practical approach, translating existing regulations to understandable requirements."
Jan van Lochem , CEO