Contract Research Organization dedicated to medical devices

Qserve CRO, a full-service contract research organization offering a full range of services, from designing and executing clinical trials to conducting PMCF surveys. Qserve CRO provides unparalleled support for medical device and IVD clinical data collection, with a practical approach and a focus on quality and compliance.

Dedicated to medical device and IVD clinical data collection

Covering all phases of clinical development, including PMCF surveys

Strategic and regulatory compliant clinical data collection

High quality combined with a practical approach

Experienced team members, short communication lines

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

Clinical Trial Services

Qserve CRO provides specialized services for medical device and IVD companies, including regulatory affairs support and a range of clinical trial services such as planning, data management, project management, writing, and monitoring.

Our clinical team is made up of experienced professionals who can provide end-to-end support for your clinical study or help with specific topics such as monitoring, medical writing, or auditing. Our experts come from diverse backgrounds, with experience working at Notified Bodies, CROs, and sponsors/manufacturers. We take a practical and strategic approach to clinical trial planning, tailoring each trial to meet the specific needs of your medical device.

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Clinical Evaluation Services

A strong clinical strategy can help bring your device to market faster and support unique claims with solid clinical evidence. The Clinical Evaluation is a crucial component of the CE marking pathway for medical devices in Europe and is necessary for market access worldwide.

Qserve CRO provides expert support for clinical development planning and Clinical Evaluation at every stage of product development. Our approach is rooted in risk management activities to ensure that your device performs as intended and is safe for patient use, in accordance with its instructions for use. Our team of experts has extensive experience in identifying the regulatory requirements that must be met and in developing the appropriate research questions to fulfill those requirements.

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PMCF Solutions

Post-Market Clinical Follow-up (PMCF) is a critical process in which manufacturers actively collect data on the clinical experience of their device after it has been released to the market. The MDR mandates that PMCF is a continuous process, and manufacturers are responsible for proactively collecting and evaluating clinical data to ensure the safety and performance of their device over its expected lifetime. At Qserve CRO, we offer comprehensive PMCF support that can range from analyzing data from existing literature or device registries to conducting new post-market clinical investigations or PMCF surveys.

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Extensive Contract Research Organization Services for Medical Devices

Clinical trials are critical in your medical device’s development and life cycle. Qserve offers tailor-made CRO service specializing in medical devices with a broad range of experience across various device categories, including cardiovascular, vascular, orthopedics, ophthalmology, urology, neurology, dental, wound care, and imaging.

Specialized in the streamlining of the development process of medical devices. Leveraging our expertise in regulations and the medical field, we guide your device efficiently through its lifecycle. As a contract research organization, we aim to facilitate swift and successful development and commercialization.

Our services encompass device testing, regulatory support, quality consulting, and clinical research. Conducting a clinical study is a significant undertaking for every medical device manufacturer, requiring a strategic and practical approach. We are here to assist you in every step, from developing the clinical strategy to designing and conducting the trial to final reporting.

Ready to streamline your medical device’s journey to market success?

Let Qserve CRO’s experienced team guide you every step of the way.
Contact us now to discuss your clinical trial needs and discover how we can help you achieve your goals efficiently and compliantly.

“Qserve CRO has experts who are very familiar with identifying the correct regulatory requirements to be addressed, as well as developing an appropriate research question(s) required to fulfill the regulatory requirements.”

Wouter Mattheussens / Clinical Project Manager

Qserve’s team has extensive awareness of medical writing, data analysis, and broad experience as writers of CEPs and CERs – we can support any medical device manufacturer. Contact us and our team will answer all your questions about our services, solutions, and budgets.

Our medical device contract research organization services

Discover our tailored solutions dedicated to propelling your IVD and medical device projects forward. From extensive research and development support to effective post-market strategies and clinical trials, our Contract Research Organization services are a roadmap to success in the dynamic healthcare landscape.

Clinical Investigation Design
Clinical Project Management
Site Feasibility Assessment, Site Selection, and Site Qualification
Regulatory submissions (Ethics Committees/ Competent Authorities)
Data management
Medical device Monitoring
Training
CEC and DMC activities
Safety Reporting
Clinical Study Reporting
Clinical Investigation Documentation
PMCF
Medical Writing
Clinical Auditing

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Therapeutic Specialties

Qserve brings a wide range of experiences in medical device CRO and development to the table. With Qserve CRO, you can expect the same high level of expertise in clinical affairs. We specialize in supporting trials across all therapeutic areas for Class I to Class III medical devices, ensuring the collection of high-quality, ISO 14155-compliant clinical data. With us, you can only expect the most comprehensive support throughout your clinical trial journey.

Full-service Contract Research Organization (CRO) for Medical Devices

Clinical Trial Services

Clinical Evaluation Services

PMCF Solutions

Extensive Contract Research Organization Services for Medical Devices

Ready to streamline your medical device’s journey to market success?

“Qserve CRO has experts who are very familiar with identifying the correct regulatory requirements to be addressed, as well as developing an appropriate research question(s) required to fulfill the regulatory requirements.”

Our medical device contract research organization services

Therapeutic Specialties

Contact Qserve CRO

We call you to discuss details (24h)

We create a custom fit offer
(within 3 days)

You choose the service you need

Newsletter

Full-service Contract Research Organization (CRO) for Medical Devices

Clinical Trial Services

Clinical Evaluation Services

PMCF Solutions

Extensive Contract Research Organization Services for Medical Devices

Ready to streamline your medical device’s journey to market success?

“Qserve CRO has experts who are very familiar with identifying the correct regulatory requirements to be addressed, as well as developing an appropriate research question(s) required to fulfill the regulatory requirements.”

Our medical device contract research organization services

Therapeutic Specialties

We call you to discuss details (24h)

We create a custom fit offer(within 3 days)

You choose the service you need

Newsletter

Complete the form below.We will contact you within 24h.

We create a custom fit offer
(within 3 days)

Complete the form below.
We will contact you within 24h.