Clinical Trials/Investigations, PMCF Studies & Registries

PMCF Surveys

Expert Clinical Strategy Support for Medical Devices and IVDs

Generating high-quality clinical evidence is a critical requirement under EU MDR and global regulations for both pre-market approval and post-market surveillance. Whether launching a first-in-human study, conducting a pivotal clinical investigation, or collecting real-world data through a registry, your clinical strategy needs to be compliant and aligned with regulatory expectations.

Qserve’s CRO provides comprehensive and practical support for clinical investigations, PMCF studies, and registry development tailored to medical devices. Our experts help you from preparing the protocol design to study execution, ensuring full compliance with ISO 14155, GCP and relevant local regulations. For PMCF studies, we create smart, risk-based strategies that meet MDR obligations while optimizing resource use.

Registries play a vital role in collecting long-term performance and safety data. Qserve has significant experience and expertise in designing, implementing, and maintaining medical device registries that provide real-world evidence for regulatory reporting, reimbursement, and clinical improvement.

Why choose Qserve as your CRO?

Our technical experts can contribute with smart planning, dedicated execution, tailor-made monitoring, and compliant documentation for your clinical trials in a wide range of therapeutic areas, such as cardiovascular, wound care, orthopedics, and diabetes. Each engagement is tailored to your specific needs to ensure the budget is in control and results meet your expectations.

Our Services

With an in-dept understanding of all the challenges in medical device trials, Qserve offers specialized solutions:

Clinical Investigation Planning

We support the design and planning of pre- and post-market clinical studies in full compliance with EU MDR and ISO 14155.

PMCF Study Design and Execution

Qserve creates and manages post-market clinical follow-up studies to collect real-world evidence and maintain CE certification.

Clinical Trial Protocol Development

Our technical experts draft scientifically and regulatory-approved protocols responding to your device’s risk and clinical claims.

Ethics Committee and CA Submissions

We make sure the preparation and submission of documentation to Ethics Committees and Competent Authorities are compliant and receive smooth approval.

Clinical Monitoring and Site Management

Our experienced CRAs ensure protocol adherence, patient safety, and data integrity across all trial sites.

Registry Design and Implementation

We design and launch medical device registries to collect long-term safety and performance data aligned with PMCF needs.

Data Management and Biostatistics

We offer end-to-end clinical data services including database setup, data cleaning, and statistical analysis for regulatory submission.

Clinical Study Project Management

Qserve provides dedicated project managers to oversee your clinical investigation from initiation to final report.

Clinical Evaluation and Report Integration

We ensure seamless integration of clinical data into your Clinical Evaluation Report (CER) to support ongoing compliance.

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FAQ

Frequently Asked Questions About Clinical Trials/Investigations, PMCF Studies & Registries

Still have questions? We are here to help, including with clinical strategy support.

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.

Under EU MDR, PMCF studies are required unless sufficient clinical evidence already exists, particularly for higher-risk and innovative medical devices.

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.

Registries collect long-term safety, performance, and usage data, supporting post-market surveillance, PMCF, reimbursement strategies, and clinical improvement.

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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