Our team is dedicated to support manufacturers through delivering cost effective clinical trails, PMCF studies or registries. As a full-service CRO, we deliver successful clinical investigations from inception to execution and closeout, supported by regulatory consulting services to keep focus on the end result: market authorization of new devices.

Post-Market Clinical Follow-up (PMCF) surveys are a cost-effective alternative to PMCF studies for legacy devices: medical devices that are successfully in the EU market already under the MDD but require their own clinical data to gain approval under the EU MDR. Qserve has already delivered hundreds of PMCF surveys that have been approved by Notified Bodies to support MDR certification. PMCF surveys require less money and time while providing high-quality clinical data to confirm the safety and performance of your devices and/or fill any clinical gaps.

We deliver clinical strategy support to help you define the most effective path from concept to market. Our team partners with you to design innovative, scalable clinical plans that align with regulatory requirements, accelerate timelines, and maximize the value of your clinical data. .

Clear, accurate, and compliant documentation is essential in highly regulated medical device clinical trials. We specialize in medical writing services that combine scientific precision with regulatory expertise. This includes literature searches, clinical evaluation plans and reports, SCCP’s and PSUR’s.

We have a team of different clinical professionals to support your interim staffing needs, whether it relates to keeping your trials running smoothly, continuation of clinical projects to gain market access, or writing clinical evaluation-related documentation. Whether you need short-term leadership, monitoring, literature searches, or project coordination, our experts step in quickly to maintain momentum and ensure compliance across all clinical operations activities.

We specialize in clinical audits to check the compliance of a running medical device or IVD trial, assess the compliance level of your CRO, monitor a clinical lab testing samples in an IVD clinical performance study, or assess your broader clinical department to ensure all applicable regulations are met and your quality system will pass external audits.

We specialize in equipping clinical teams with the skills and insights they need to navigate the complexities of clinical trials and wider clinical business aspects while maintaining regulatory compliance. We offer live, remote, in-company and public training and our training platform Qserve Learn offers an ever-expanding portfolio of e-module courses to cover all aspects of clinical operations.

We design and execute IVD clinical performance studies to demonstrate the accuracy, reliability, and clinical value of your (companion) diagnostic device. Our team ensures your study generates robust data to support regulatory approval, market access, and long-term success. This ranges from study protocol design, submissions to competent authorities and ethics committees, monitoring of central labs to writing clinical performance reports supporting your submission for market authorization.