July 10, 2020
EU publishes sector specific guidance on EU-UK relation change end of the year. What’s relevant for devices?!
The European has adopted yesterday a Communication to help national authorities, businesses and citizens prepare for the inevitable changes that will arise at the end of the transition period of the EU and UK in the Brexit separation process. Changes will occur to cross-border exchanges between the EU and the UK as of 1 January 2021– irrespective of whether an agreement on a future partnership has been concluded or not.
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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