On your Marks! The countdown has begun

Today marks yet another milestone in the EU-MDR development: the day on which the EU-MDR and EU-IVDR are being published, with 20 days to go until the day of entry into force, and a total of 1116 days for the date of application of the MDR and 1847 days for the IVDR. 

Practical support to accelerate your market approval

Qserve is the largest consultant company in the EU that is 100% focused on medical devices.  We are able to provide you with detailed knowledge and experience on the broad range of expertise needed. We have subject matters experts (SME) on all aspects of medical device regulation. 

Regulatory Affairs

Regulations vary depending on the medical device and market you wish to enter. Our specialized teams will help you comply with all necessary regulations.

Clinical Affairs

Experience a practical approach based on your existing regulatory data. Our team supports medical writing of clinical evaluations (MEDDEV 2.7.1.), as well as full-service CRO activities.

Quality Assurance

Ensure that all quality performance requirements are met by implementing and maintaining a Quality Management System (QMS) based on local requirements.

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

News

May 18, 2017

EU-MDR and EU-IVDR are live!

On the 5th of May 2017, the long awaited European Medical Device Regulation was published. The EU-MDR will affect all Medical Device manufacturers. Gert Bos shares his knowledge on this matter: Key changes with EU-MDR and EU-IVDR, Some Things to Expect During the Transition Period and Steps to Begin Taking Now.
May 15, 2017

The first EU-MDR app by Qserve that gives insight in the compliance status is now available

Qserve designed a dedicated app that can be used as a tool to assess a company’s EU MDR implementation status and provide next steps on the road to compliance. 
May 05, 2017

On your Marks! The countdown has begun

Today marks yet another milestone in the EU-MDR development: the day on which the EU-MDR and EU-IVDR are being published, with 20 days to go until the day of entry into force, and a total of 1116 days for the date of application of the MDR and 1847 days for the IVDR. 

May 01, 2017

Founder Qserve Group Willibrord Driessen completes transition to new leadership

QserveÒ Group, a leading consulting group in medical device compliance, today announced the completion of the transition to new leadership for the company.

April 24, 2017

Meet our Qserve team at the MedTech Summit 2017

April 12, 2017

Entering the Twilight Zone for legacy products

With the final steps of the approval of the new EU-MDR and EU-IVDR being moments away, the debates are moving to understand the impact and ramifications of the hard and soft transitioning specifications.