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.
Regulations vary depending on the medical device and market you wish to enter. Our specialized teams will help you comply with all necessary regulations.
Analyze clinical data to verify the safety and performance of your medical device. Assessment is based on existing literature and clinical studies.
Ensure that all quality performance requirements are met by implementing and maintaining a Quality Management System (QMS) based on local requirements.
All expertise fields
"Choose 1 partner for medical device regulatory. With the right partner you realize your company’s full potential. Qserve is such a partner."
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.
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.
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.