Clinical Research Services for Medical Devices and IVD
We support manufacturers with cost-effective clinical trials as a full-service CRO, including strategic consulting to achieve successful regulatory approvals and faster time to market.
Integrated Clinical and Regulatory Support for Medical Device and IVD Manufacturers
Integrated Clinical and Regulatory Support for Medical Device and IVD Manufacturers
Medical device and IVD manufacturers increasingly need their own clinical data to support their market approval, either pre- or post-market. It is often a challenge to address the complexities of conducting clinical studies, ensuring compliant and cost-efficient execution, and engaging with authorities and Notified Bodies to obtain market authorization in a timely and predictable manner.
Why Clinical Research Matters for Medical Devices & IVDs
Clinical research is essential to demonstrate:
- Safety, performance, and effectiveness of your medical device or diagnostic in real-world use
- Regulatory compliance under frameworks such as ISO 14155 ISO 20916and ISO 20916 EU MDR/IVDR, and GCP guidelines
- Robust clinical evidence to support submissions to Notified Bodies, the FDA, or global regulatory agencies
A strong clinical strategy not only accelerates regulatory approval but also strengthens your commercial positioning and reduces operational risk.
At Qserve, we combine many years of experience in both clinical research and regulatory and clinical consulting. We have a uniquely integrated approach in which our CRO team executes all aspects of clinical studies efficiently. In contrast, our MD and IVD regulatory consulting teams have years of experience with key Notified Bodies and the FDA to help achieve market authorization with the highest possible success rate. We combine this with the possibility of tailored training through our Qserve Learn platform and state-of-the-art software to support people development and operational excellence in clinical research.
Our Clinical Operations services cover multiple disciplines. Discover all of them:
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.
PMCF Surveys
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.
Clinical Strategy Support
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. .
Medical Writing
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.
Interim Support
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.
Audits & Assessments
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.
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.
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.
Step-by-Step Guide to Conducting Clinical Research for Medical Devices & IVDs
Step 1: Define Your Research Objective
Begin by identifying the primary goal of your study: evaluating safety, performance, usability, or clinical effectiveness. Determine the target population and relevant endpoints to ensure your research addresses the right questions. Your objectives must align with regulatory requirements, including EU MDR, ISO 14155, and FDA guidance, to maintain compliance throughout the study.
Step 2: Conduct a Regulatory & Literature Review
Next, review existing clinical evidence to avoid duplication and identify any knowledge gaps your study should address. This step also involves examining relevant standards, such as ISO 14155 for medical devices and GCP guidelines, to ensure that your research design and methodology meet current regulatory expectations.
Step 3: Choose the Study Type
Select the study type that best fits your research objectives. An observational study collects real-world evidence without intervention, while an interventional clinical trial tests a medical device or IVD under controlled conditions. Post-Market Clinical Follow-Up (PMCF) studies are mandatory for ongoing compliance with the EU MDR, and performance studies for IVDs are designed to evaluate analytical and clinical performance. The choice of study type will shape your protocol, regulatory approach, and data collection methods.
Step 4: Prepare a Study Protocol
Develop a detailed study protocol that outlines the study objectives, design, sample size, endpoints, inclusion and exclusion criteria, and statistical methods. The protocol should also define monitoring and data-collection procedures to ensure accurate, consistent data. Once complete, the protocol is submitted to the appropriate Ethics Committees or Institutional Review Boards (IRBs) for approval before the study can begin.
Step 5: Select Study Sites & Investigators
Choose study sites with access to the relevant patient population and with staff experienced in clinical research. Investigators and site personnel must be trained in the study procedures, device use, and reporting requirements to ensure the study is conducted consistently and in compliance with regulatory standards.
Step 6: Obtain Regulatory Approvals
Submit the study protocol to the relevant Notified Bodies, Competent Authorities, or the FDA, depending on the market and regulatory requirements. Obtain informed consent from all participants before any procedures are conducted, and ensure full compliance with data privacy regulations, such as GDPR, throughout the study.
Step 7: Conduct the Study
Carry out the study in accordance with the approved protocol and in compliance with GCP and ISO 14155 standards. Collect data systematically and maintain accurate, verifiable records to support both internal evaluation and regulatory submissions.
Step 8: Analyze the Data
Once data collection is complete, perform statistical analyses according to the pre-defined plan. Evaluate study endpoints related to safety, performance, and effectiveness. Summarize the findings in clinical study reports that are suitable for both internal review and regulatory submission.
Step 9: Prepare a Clinical Evaluation
Integrate the study results with existing literature and any post-market data to perform a comprehensive clinical evaluation. Assess whether the device meets all relevant safety and performance requirements. The conclusions are then documented in Clinical Evaluation Reports (CERs) to support regulatory submissions and product compliance.
Step 10: Post-Market Follow-Up
After the product is on the market, conduct PMCF studies or surveys to monitor long-term performance and safety. Update risk management files and regulatory documentation based on the findings and implement any necessary improvements or additional training to maintain compliance and ensure continued device effectiveness.
Step-by-Step Guide to Conducting Clinical Research for Medical Devices & IVDs
Step 1: Define Your Research Objective
Begin by identifying the primary goal of your study: evaluating safety, performance, usability, or clinical effectiveness. Determine the target population and relevant endpoints to ensure your research addresses the right questions. Your objectives must align with regulatory requirements, including EU MDR, ISO 14155, and FDA guidance, to maintain compliance throughout the study.
Step 2: Conduct a Regulatory & Literature Review
Next, review existing clinical evidence to avoid duplication and identify any knowledge gaps your study should address. This step also involves examining relevant standards, such as ISO 14155 for medical devices and GCP guidelines, to ensure that your research design and methodology meet current regulatory expectations.
Step 3: Choose the Study Type
Select the study type that best fits your research objectives. An observational study collects real-world evidence without intervention, while an interventional clinical trial tests a medical device or IVD under controlled conditions. Post-Market Clinical Follow-Up (PMCF) studies are mandatory for ongoing compliance with the EU MDR, and performance studies for IVDs are designed to evaluate analytical and clinical performance. The choice of study type will shape your protocol, regulatory approach, and data collection methods.
Step 4: Prepare a Study Protocol
Develop a detailed study protocol that outlines the study objectives, design, sample size, endpoints, inclusion and exclusion criteria, and statistical methods. The protocol should also define monitoring and data-collection procedures to ensure accurate, consistent data. Once complete, the protocol is submitted to the appropriate Ethics Committees or Institutional Review Boards (IRBs) for approval before the study can begin.
Step 5: Select Study Sites & Investigators
Choose study sites with access to the relevant patient population and with staff experienced in clinical research. Investigators and site personnel must be trained in the study procedures, device use, and reporting requirements to ensure the study is conducted consistently and in compliance with regulatory standards.
Step 6: Obtain Regulatory Approvals
Submit the study protocol to the relevant Notified Bodies, Competent Authorities, or the FDA, depending on the market and regulatory requirements. Obtain informed consent from all participants before any procedures are conducted, and ensure full compliance with data privacy regulations, such as GDPR, throughout the study.
Step 7: Conduct the Study
Carry out the study in accordance with the approved protocol and in compliance with GCP and ISO 14155 standards. Collect data systematically and maintain accurate, verifiable records to support both internal evaluation and regulatory submissions.
Step 8: Analyze the Data
Once data collection is complete, perform statistical analyses according to the pre-defined plan. Evaluate study endpoints related to safety, performance, and effectiveness. Summarize the findings in clinical study reports that are suitable for both internal review and regulatory submission.
Step 9: Prepare a Clinical Evaluation
Integrate the study results with existing literature and any post-market data to perform a comprehensive clinical evaluation. Assess whether the device meets all relevant safety and performance requirements. The conclusions are then documented in Clinical Evaluation Reports (CERs) to support regulatory submissions and product compliance.
Step 10: Post-Market Follow-Up
After the product is on the market, conduct PMCF studies or surveys to monitor long-term performance and safety. Update risk management files and regulatory documentation based on the findings and implement any necessary improvements or additional training to maintain compliance and ensure continued device effectiveness.
Prevent Loss and Operational Inefficiency
In clinical research, the vast amount of regulatory requirements dictate in detail how a study is executed. Most gains in time and costs can be obtained in developing the right clinical strategy with the aim of market approval. The experts of Qserve combine the right regulatory knowledge with cost-effective execution of studies to drive down costs and time-to-market with a high success rate to obtain regulatory approval.
At Qserve, we help you to deliver the best possible clinical strategy and clinical study execution together in terms of regulatory compliance, costs, time-to-market, and interaction with approval bodies, Notified Bodies or FDA alike. We complement this by delivering tailored training programs that keep your teams up to date with the latest regulations and best practices. We work with you to standardize processes and implement digital tools that enhance data management and trial oversight. Additionally, we provide strategic guidance on risk management and foster improved collaboration among all stakeholders, ensuring smoother communication and faster resolution of challenges.
FAQ
Couldn't find your question?
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.