Practical support to accelerate your market approval

Our philosophy is to optimize and customize our advice using a practical approach to support each individual company in the most efficient and cost-effective manner. 

Regulatory Compliance

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 Evaluation

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

Services

How can we help you?

Qserve offers a full regulatory service package for medical device development. Together with our partners, we assist you in choosing the most beneficial strategy to get your medical device to the global market.

 

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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