January 08, 2019
MDR to move into next implementation phase – the vision of Scrooge
New Year’s Day, a time to navigate the grey divide between past, present and future. Having watched any of the versions of Scrooge during the holiday break will lead you to the question: who is Scrooge in the EU Saga? I guess it may depend on many factors. For me it could well be seen in the light of the EU-MDR.

Your Global Medtech Partner for Regulatory, Clinical & Quality Compliance

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 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