Clinical Trials for Medical Devices and IVD
Specialized CRO support for pre-market clinical investigations, post-market studies, and device registries, delivering compliant, inspection-ready clinical evidence for global market access.
Why medical device clinical trials need a specialized CRO
Why medical device clinical trials need a specialized CRO
Medical device clinical trials generate the pre-market and post-market clinical evidence regulators require for FDA clearance, EU CE marking, and continued market authorization. Device studies differ from pharmaceutical trials in a key respect: iterative design changes, operator-dependent performance, and multi-country regulatory frameworks demand a CRO built specifically around device development, not one adapted from drug trial methodology.
- Complex study designs that reconcile regulatory requirements with practical site execution
- Country-specific requirements across the EU's national competent authorities and ethics committees
- Site recruitment and retention in competitive device trial landscapes
- Data quality management that prevents protocol deviations before they become inspection findings
- Multi-country coordination across EU MDR, FDA 21 CFR Part 812, Health Canada, and other frameworks
- Post-market evidence generation to sustain market authorization and support reimbursement, often through PMCF surveys and studies
Without device-specific clinical trial expertise, manufacturers risk costly delays, rejected submissions, inadequate evidence, and failed regulatory inspections.
How a medical device CRO differs from a pharmaceutical CRO
Qserve is a specialized medical device CRO built exclusively for medical device and IVD clinical research, not a pharmaceutical CRO. Device trials revolve around iterative design changes, operator technique, and country-specific device regulations rather than dose-response or drug metabolism. Our team pairs regulatory expertise in MDR, IVDR, FDA IDE pathways, ISO 14155, and GCP with hands-on device trial operations experience.
We also bring real-world pragmatism: site relationships and operational judgment to address enrollment shortfalls and data quality issues as they surface, not just on paper.
Our Comprehensive Medical Device & IVD Clinical Trial Services:
Clinical Investigation planning & strategy
We design compliant clinical development programs aligned with your regulatory pathway and commercial objectives, from FDA 510(k) to EU CE marking.
Clinical Trial Protocol Development
Our experts develop scientifically rigorous, inspection-ready protocols that satisfy regulatory requirements while remaining practical for site execution. We ensure full compliance with ISO 14155 and GCP while addressing device-specific safety and enrollment optimization.
Ethics Committee & Regulatory Submissions
We manage all regulatory and ethics submissions across global jurisdictions, including FDA IDE applications, EU MDR Clinical Investigation Plans, Health Canada CTAs, and submissions to TGA, PMDA, NMPA, and other regional authorities.
Site Selection & Feasibility
We identify and qualify clinical sites with the right patient populations, investigator expertise, and operational capabilities through comprehensive feasibility assessments and qualification visits.
Clinical Trial Monitoring & Oversight
Our experienced Clinical Research Experts provide on-site and remote monitoring to ensure protocol compliance, data integrity, patient safety, and regulatory adherence throughout your trial.
Data Management & Biostatistics
We provide complete clinical data management from EDC system setup and validation through statistical analysis and regulatory reporting.
Clinical Study Project Management
Every study is assigned a dedicated Clinical Project Manager who coordinates all trial activities, maintains timelines and budgets, and serves as your single point of contact.
Clinical Study Reporting & Regulatory Integration
We deliver comprehensive clinical study reports that meet regulatory standards for FDA submissions (IDE, 510(k), PMA) and EU Clinical Investigation Reports that comply with MDR requirements.
When you need dedicated clinical trial support
Manufacturers turn to a dedicated clinical trial partner at three points: running a first-in-human feasibility study, conducting a pivotal clinical investigation for FDA PMA or EU CE marking, or collecting post-market real-world data to sustain market authorization. Each stage carries its own evidentiary bar, and study design has to match it. For IVD manufacturers, the equivalent evidence sits in IVD clinical performance studies rather than a device clinical investigation.
How we manage risk across your clinical trial
Clinical trials without effective oversight are prone to delays, and poor site performance or incomplete documentation can trigger inspection findings, rejected submissions, or added study requirements. Our structured, regulation-driven approach — covering study design, site performance, monitoring, and documentation — keeps timelines, cost, and compliance under your control.
When you need dedicated clinical trial support
Manufacturers turn to a dedicated clinical trial partner at three points: running a first-in-human feasibility study, conducting a pivotal clinical investigation for FDA PMA or EU CE marking, or collecting post-market real-world data to sustain market authorization. Each stage carries its own evidentiary bar, and study design has to match it. For IVD manufacturers, the equivalent evidence sits in IVD clinical performance studies rather than a device clinical investigation.
How we manage risk across your clinical trial
Clinical trials without effective oversight are prone to delays, and poor site performance or incomplete documentation can trigger inspection findings, rejected submissions, or added study requirements. Our structured, regulation-driven approach — covering study design, site performance, monitoring, and documentation — keeps timelines, cost, and compliance under your control.
Still have questions? We are here to help, including with clinical strategy support.
What is the difference between a clinical investigation and a PMCF study?
A clinical investigation is typically conducted pre-market to establish safety and performance, while a PMCF study is conducted post-market, designed to gather real-world data and fulfill EU MDR requirements.
Are PMCF studies mandatory under EU MDR for all medical devices?
Under EU MDR, PMCF studies are required unless sufficient clinical evidence already exists, particularly for higher-risk and innovative medical devices.
How does Qserve support ISO 14155-compliant clinical trials?
Qserve provides full-service support for clinical trials aligned with ISO 14155:2026. Our experts have many years of experience to ensure the execution of compliant studies, and using proven eTMF, CTMS and EDC software to maintain full transparency and recording of all documentation.
What types of data can be collected through a medical device registry?
Registries collect long-term safety, performance, and usage data, supporting post-market surveillance, PMCF, reimbursement strategies, and clinical improvement. See our clinical device registries page for how a registry differs from a PMCF study.
How long does it take to prepare and start a clinical investigation?
Timelines vary, but with Qserve’s support in protocol development, ethics submission, and project management, studies can be ready for initiation in a matter of months.
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