Clinical Research Services for Medical Devices and IVD
A full-service CRO with regulatory consultants in the same business, running your clinical trials, PMCF studies and IVD performance studies toward one goal: market authorization.
The problem most manufacturers hit
The problem most manufacturers hit
Medical device and IVD manufacturers increasingly need their own clinical data to support market approval, before launch or after it. Studies stall when regulatory requirements are treated as paperwork rather than a design input: protocols bounce back from ethics committees, and Notified Bodies raise queries a stronger study design would have prevented.
The real cost sits in the redo, not the study itself. A clinical strategy chosen before the protocol is written is what keeps timeline and budget predictable. It's the difference between one round of questions from an Ethics Committee or Competent Authority and three.
Why a CRO with regulatory consultants in-house is different
Qserve is a CRO with regulatory consultants within the same business, not two vendors handed back and forth. Our clinical team designs and runs the study; our regulatory consultants have sat across the table from Notified Bodies and the FDA on hundreds of submissions. That combination shapes the protocol from day one around what a reviewer will actually ask.
We pair this with tailored training through Qserve Learn and software built for study oversight, so operational consistency doesn't depend on any one person's memory.
What is clinical research for medical devices and IVD?
Clinical research for medical devices and IVDs is the systematic collection of safety and performance data in humans, used to show a device works as intended and meets regulatory expectations. It covers clinical trials, IVD performance studies, PMCF studies and surveys, and clinical registries, operating under EU MDR, IVDR, ISO 14155, ISO 20916 and GCP guidance.
When do you need clinical research?
Clinical research becomes necessary at several points in a device's life. You're likely facing it if you:
- Need pre-market clinical or performance data for a new device or IVD
- Have PMCF or PMPF obligations under EU MDR or IVDR post-market
- Need clinical evidence to support a Notified Body or FDA submission
- Require an EU-based legal representative to run a clinical investigation in the EU
- Want a clinical registry to track long-term device performance
Our Clinical Research Services:
PMCF Surveys & Studies
PMCF surveys and studies give medical device manufacturers real-world evidence of a device's performance and safety, satisfying post-market requirements under the EU MDR and FDA. Qserve manages the full lifecycle, from protocol development and ethics submissions to site identification, investigator engagement, data collection, and reporting, so safety and performance are documented with scientific integrity.
IVD Clinical Performance Studies
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.
Clinical Trials
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.
Clinical Registries
We support your device lifecycle end-to-end so you can generate reliable, real-world evidence with speed and compliance.
Clinical Training
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.
EU Legal Representation
Conducting a clinical investigation in the European Union demands full compliance with the EU Medical Device Regulation (EU MDR 2017/745), including the appointment of an EU‑based Legal Representative for non‑EU manufacturers. Qserve provides this essential service.
How clinical research works
Ten steps take a study from objective to post-market follow-up:
1. Define your research objective. Identify what you're evaluating — safety, performance, usability or clinical effectiveness — and the target population and endpoints. Objectives need to align with EU MDR, ISO 14155 and FDA guidance from the outset, not after the protocol is drafted.
2. Review regulation and existing literature. Check existing clinical evidence to avoid duplication and surface gaps your study should close, and confirm the standards in play — ISO 14155 for devices, GCP guidance more broadly — before locking the design.
3. Choose the study type. An observational study collects real-world evidence without intervention; an interventional trial tests a device under controlled conditions. PMCF studies address ongoing EU MDR compliance obligations, and performance studies for IVDs evaluate analytical and clinical performance. This choice shapes the protocol, regulatory route and data collection method
4. Prepare a study protocol. Set out objectives, design, sample size, endpoints, inclusion and exclusion criteria and statistical methods, along with monitoring and data-collection procedures. The protocol then goes to the relevant Ethics Committee or Institutional Review Board for approval.
5. Select study sites and investigators. Choose sites with access to the right patient population and staff experienced in clinical research, and train investigators and site personnel on procedures, device use and reporting.
6. Obtain regulatory approvals. Submit the protocol to the relevant Notified Body, Competent Authority or the FDA. Obtain informed consent from every participant, and confirm data-privacy compliance, including GDPR, throughout.
7. Conduct the study. Run it to the approved protocol, in line with GCP and ISO 14155, and keep systematic, verifiable records to support both internal review and regulatory submission.
8. Analyze the data. Run the pre-defined statistical analysis and evaluate the safety, performance and effectiveness endpoints. Summarize findings in clinical study reports suitable for internal review and regulatory submission.
9. Prepare a clinical evaluation. Integrate study results with existing literature and post-market data to assess whether the device meets safety and performance requirements, and document the conclusions in a Clinical Evaluation Report.
10. Follow up post-market. Run PMCF studies or surveys to track long-term performance and safety, then update risk management files and regulatory documentation against the findings.
How clinical research works
Ten steps take a study from objective to post-market follow-up:
1. Define your research objective. Identify what you're evaluating — safety, performance, usability or clinical effectiveness — and the target population and endpoints. Objectives need to align with EU MDR, ISO 14155 and FDA guidance from the outset, not after the protocol is drafted.
2. Review regulation and existing literature. Check existing clinical evidence to avoid duplication and surface gaps your study should close, and confirm the standards in play — ISO 14155 for devices, GCP guidance more broadly — before locking the design.
3. Choose the study type. An observational study collects real-world evidence without intervention; an interventional trial tests a device under controlled conditions. PMCF studies address ongoing EU MDR compliance obligations, and performance studies for IVDs evaluate analytical and clinical performance. This choice shapes the protocol, regulatory route and data collection method
4. Prepare a study protocol. Set out objectives, design, sample size, endpoints, inclusion and exclusion criteria and statistical methods, along with monitoring and data-collection procedures. The protocol then goes to the relevant Ethics Committee or Institutional Review Board for approval.
5. Select study sites and investigators. Choose sites with access to the right patient population and staff experienced in clinical research, and train investigators and site personnel on procedures, device use and reporting.
6. Obtain regulatory approvals. Submit the protocol to the relevant Notified Body, Competent Authority or the FDA. Obtain informed consent from every participant, and confirm data-privacy compliance, including GDPR, throughout.
7. Conduct the study. Run it to the approved protocol, in line with GCP and ISO 14155, and keep systematic, verifiable records to support both internal review and regulatory submission.
8. Analyze the data. Run the pre-defined statistical analysis and evaluate the safety, performance and effectiveness endpoints. Summarize findings in clinical study reports suitable for internal review and regulatory submission.
9. Prepare a clinical evaluation. Integrate study results with existing literature and post-market data to assess whether the device meets safety and performance requirements, and document the conclusions in a Clinical Evaluation Report.
10. Follow up post-market. Run PMCF studies or surveys to track long-term performance and safety, then update risk management files and regulatory documentation against the findings.
FAQ
Couldn't find your question?
Can Qserve support clinical research outside Europe?
Yes. We support clinical and performance studies with regulatory considerations across Europe, the United States and Asia, aligning local execution with a single global strategy.
How long does a clinical or performance study take?
Timelines vary by device class, study type, and Notified Body or Ethics Committee turnaround, so there's no single figure that fits every project. Classification and protocol design done early are what most reliably shorten the timeline — the fastest studies are the ones planned around the destination submission from day one.
What is clinical research for medical devices and IVDs?
Clinical research is the systematic gathering of safety and performance data from humans to demonstrate that your medical device or IVD works as intended and meets regulatory expectations. It includes clinical trials, performance studies, PMCF studies, and other data‑collection efforts.
Why do medical devices need clinical research?
Regulatory frameworks such as the EU MDR and ISO 14155 require manufacturers to provide clinical evidence demonstrating safety and performance. Clinical research fulfills this requirement and supports successful regulatory approval.
How does Qserve combine clinical and regulatory support?
Qserve’s integrated approach brings together CRO clinical execution with regulatory consulting expertise — enabling strategic study design, compliant execution, and optimized regulatory submissions that improve approval outcomes.
What’s the difference between PMCF surveys and PMCF studies?
PMCF studies are formal clinical investigations required for ongoing compliance. At the same time, PMCF surveys use structured questionnaires to gather real-world evidence more cost-efficiently — often beneficial for legacy devices transitioning to MDR compliance.
Can Qserve support global clinical research?
Yes. We offer support for clinical studies with regulatory considerations in key markets, including Europe, the United States, and Asia, ensuring local compliance alongside global strategy.
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