Clinical Trials for Medical Devices and IVD
Expert CRO support for clinical investigations, post-market studies, and device registries, delivering compliant, high-quality clinical evidence for global market access.
Clinical Evidence Generation for Medical Devices: Pre-Market to Post-Market
Clinical Evidence Generation for Medical Devices: Pre-Market to Post-Market
Generating robust clinical evidence isessential for regulatory approval and ongoing compliance across global markets.Whether you're conducting a first-in-human feasibility study, a pivotalclinical investigation for FDA PMA or EU CE marking, orcollecting real-world data through post-market surveillance, your clinicalstrategy must be scientifically sound and regulatory-compliant.
The challenges are significant:
- Complex study designs that balance regulatory requirements with practical execution
- Country specific requirements we have a complete overview of all the different requirements for the EU countries
- Site recruitment and retention in competitive clinical trial landscapes
- Data quality management to prevent protocol deviations and regulatory findings
- Multi-country coordination across different regulatory frameworks (EU MDR, FDA 21 CFR Part 812, Health Canada, etc.)
- Post-market evidence generation to maintain market authorization and support reimbursement
Without specialized medical device clinical trial expertise, manufacturers risk costly delays, rejected submissions, inadequate evidence, and failed regulatory inspections.
A Specialized Medical Device CRO: FromProtocol to Publication
We are not a pharmaceutical CRO. We are a specialized Contract Research Organization built exclusively for medical device and IVD clinical research.
Our team combines:
- Regulatory expertise in MDR, IVDR, FDA IDE pathways, ISO 14155, and GCP requirements
- Clinical operations experience managing complex device trials across multiple therapeutic areas
- Real-world pragmatism to navigate site challenges, enrollment obstacles, and data quality issues
We act as a seamless extension of yourclinical team, providing the infrastructure, expertise, and hands-on executionneeded to generate inspection-ready clinical evidence.
Our Comprehensive 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.
Clinical trials that lack effectiveoversight are prone to delays and costly rework. Poor site performance orincomplete documentation can result in inspection findings, rejectedsubmissions, or additional study requirements.
Our structured, regulatory-driven approachminimizes risk while maintaining operational efficiency. By proactivelymanaging study design, site performance, monitoring activities, anddocumentation, we help you maintain control over timelines, costs, and compliance.We deliver high-quality clinical evidence that supports regulatory approval andmarket success.
Clinical trials that lack effectiveoversight are prone to delays and costly rework. Poor site performance orincomplete documentation can result in inspection findings, rejectedsubmissions, or additional study requirements.
Our structured, regulatory-driven approachminimizes risk while maintaining operational efficiency. By proactivelymanaging study design, site performance, monitoring activities, anddocumentation, we help you maintain control over timelines, costs, and compliance.We deliver high-quality clinical evidence that supports regulatory approval andmarket success.
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. 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.
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.