Medical Device CRO

Qserve, your full-scope CRO for Medical Device Clinical Trials

Medical Device CRO

Full scope CRO for Medical Device 

Clinical trials play a crucial role in your medical device's development and life cycle. Qserve offers a comprehensive CRO service specializing in medical devices. While our primary focus is in Europe, we can also support studies with sites in the US and Asia.

At Qserve, we specialize in streamlining 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. Qserve is 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.

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Experience and Expertise in Medical Device Clinical Trials

Qserve CRO is a leading medical device-focused CRO with extensive experience across various device categories, including cardiovascular, vascular, orthopedics, ophthalmology, urology, neurology, dental, wound care, and imaging. We prioritize a strategic, Notified body-approved, and practical approach to ensure the success of your clinical trials.

Our clinical team brings a wealth of experience from their backgrounds at Notified Bodies, CROs, and Sponsors/Manufacturers. This diverse expertise, combined with Qserve's profound regulatory knowledge, ensures the efficiency and compliance of your clinical trials.

We specialize in tailoring clinical trials to meet the specific needs of your medical device, offering expertise in feasibility, pre-market, and post-market studies ranging from class I to class III devices. Trust Qserve CRO to deliver exceptional results through our experienced and dedicated team.

Therapeutic Specialties

Qserve brings extensive experience in regulatory affairs and quality 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. Trust Qserve CRO for comprehensive support throughout your clinical trial journey.


We offer CRO support in the following areas

Clinical Strategy
Study design, global registration requirements, and sample size.

Clinical Study startup
Site feasibility/selection and essential documentation.

CA/EC submissions
Submission package and EC/CA/IRB/Hospital contact.

Medical Writing
Protocol, ICF, and an IB report.

ISO14155 & (GCP) Training
ISO14155, training, site initiation, and study-specific training.

CRAs, on-site (initiation, interim, close-out), remote, and risk-based.

Clinical Data Management
(e) CRF, EDC, safety monitoring, and statistical analysis.

Clinical Auditing
Site, CRO, contractor, sponsor, and pre-inspection.

Clinical Project Management
Full project management, investigator meetings, and interim Clinical Management.