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
Analyze clinical data to verify the safety and performance of your medical device. Assessment is based on existing literature and clinical studies.

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

All expertise fields

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

1 partner

"Choose 1 partner for medical device regulatory. With the right partner you realize your company’s full potential. Qserve is such a partner."

News

RSS

February 15, 2017 Announcing Gert Bos as member of the RAPS Board of Directors

We are pleased to announce the appointment of Gert W. Bos, PhD, FRAPS, executive director and partner at Qserve Group as a new member of the RAPS Board of Directors.

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January 25, 2017 First EU MDR workshop was a success and all speakers for the February Clinical session are confirmed

On the 16th of January, 2017 the first Qserve EU MDR workshop took place in Amsterdam, The Netherlands. We were very pleased with the positive responses that were submitted through evaluations.

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January 24, 2017 Wiebe Postma, an experienced Clinical researcher joins Qserve Clinical team

It is with pleasure that we introduce Wiebe Postma as a member of our expanding team of experts. Wiebe brings experience in clinical evaluation and clinical investigation (CRO) and will join us to strengthen the Clinical Evaluation Business area, supporting also the growing need for clinical data in the field.

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