September 02, 2019
Focus on MDR compliance, as extension limited to class Ir !
With just 9 months to go until the go-live date of the EU-MDR, the stress and anxiety is rapidly increasing. Cries for extension are met with slow progress in implementation of the new legislation. On the IVDR front it is still quiet, as many appear not to focus on this challenge yet, as there is plenty of time. So, what is happening? A selection, to get you thinking and enhance your efforts to comply!

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 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