Qserve is a Full-service Medical device dedicated Contract Research Organization

Qserve CRO is a full-service contract research organization with experience in designing and executing clinical trials, ranging from early pre-market to PMCF surveys for the Medical Devices industries. 

We have the knowledge, capabilities, and processes that are needed to develop and run a successful clinical trial while ensuring trial quality and compliance with the European Medical Device Regulation (EU MDR), which is vital to obtain and/or maintain CE marking.

Dedicated to medical device clinical data collection

Covering all phases of clinical development, including PMCF

Strategic and regulatory compliant clinical data collection

High quality combined with a practical approach

Experienced team members, short communication lines

Qserve is a Full-service Medical device dedicated Contract Research Organization

Qserve CRO is a full-service contract research organization with experience in designing and executing clinical trials, ranging from early pre-market to PMCF surveys for the Medical Devices industries. 

We have the knowledge, capabilities, and processes that are needed to develop and run a successful clinical trial while ensuring trial quality and compliance with the European Medical Device Regulation (EU MDR), which is vital to obtain and/or maintain CE marking.

Dedicated to medical device clinical data collection

Dedicated to all phases of clinical development, including PMCF

Strategic and regulatory compliant clinical data collection

High quality combined with a practical approach

Experienced team members, short communication lines

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Clinical Trial Services

At Qserve CRO, we offer medical device dedicated services that include regulatory affairs support besides clinical trial planning, clinical data management, clinical project management, clinical writing, and clinical trial monitoring.

Our clinical team can support your clinical study from start to finish, or can support specific topics such as monitoring, medical writing or auditing. Our team is full of Experts with experience working at Notified Bodies, CROs, and sponsors/manufacturers.  We believe in a strategic and overall practical approach through setting-up clinical trials tailored to your medical device’s specific needs.

Post Market Clinical Follow-up (PMCF)

PMCF is an active collection of data on clinical experience with your device after market release. PMCF is a continuous process, regulated in the MDR. The regulation specifies the manufacturer’s responsibility to proactively collect and evaluate clinical data to meet the safety and performance requirements of the device during its expected lifetime.

Qserve CRO offers PMCF support that can range from an analysis of data from literature or existing device registries to performing a new post-market clinical investigation or a PMCF survey.

“Our clinical team will be happy to discuss any clinical research needs you might have. Don’t hesitate to contact us for more information about our CRO solutions and learn about the custom-made and cost-effective options we can create for you.”

Iris Verboven – business operations manager clinical

Clinical Evaluation Services

A good clinical strategy gives you a competitive advantage, by bringing your device to market faster and supporting unique claims with solid clinical evidence. The Clinical Evaluation is a critical element in the CE marking pathway for a medical device on the European market. In addition, the Clinical Evaluation is required for market access in the rest of the world.

Qserve offers support for clinical development planning and Clinical Evaluation during various phases of product development, underpinned by risk management activities. Clinical Evaluation is the final validation of a medical device to confirm that the device performs as intended and can safely be used in patients in accordance with its instructions for use.

Our experts are familiar with identifying the correct regulatory requirements to be addressed, as well as developing an appropriate research question(s) required to fulfil the regulatory requirements.

“Our clinical team will be happy to discuss any clinical research needs you might have. Don’t hesitate to contact us for more information about our CRO solutions and learn about the custom-made and cost-effective options we can create for you.”

Iris Verboven – business operations manager clinical

Clinical Evaluation Services

A good clinical strategy gives you a competitive advantage, by bringing your device to market faster and supporting unique claims with solid clinical evidence. The Clinical Evaluation is a critical element in the CE marking pathway for a medical device on the European market. In addition, the Clinical Evaluation is required for market access in the rest of the world.

Qserve offers support for clinical development planning and Clinical Evaluation during various phases of product development, underpinned by risk management activities. Clinical Evaluation is the final validation of a medical device to confirm that the device performs as intended and can safely be used in patients in accordance with its instructions for use.

Our experts are familiar with identifying the correct regulatory requirements to be addressed, as well as developing an appropriate research question(s) required to fulfil the regulatory requirements.