Clinical Investigations for Medical Devices & IVD
We offer a full spectrum of solutions to support your clinical investigation needs, from development of clinical strategies, writing clinical protocols, executing clinical trials, conducting PMCF surveys to writing clinical evaluations.
Navigate Clinical Strategy Challenges with Confidence
Navigate Clinical Strategy Challenges with Confidence
Clinical investigations are important for medical devices and IVD’s because they ensure that the device is safe, effective, compliant, and usable in real clinical settings. Without strong clinical investigations, even a well-designed device can fail to protect patients, meet regulations, or succeed in the market.
Qserve understands in detail the importance of professionally deliver Clinical investigations in order to:
- Ensure the device is used safely, correctly, and consistently
- Generate clinical evidence for safety, performance, and effectiveness
- Maintain regulatory and ethical compliance
- Support patient safety and data integrity
- Respect the agreed budget
Qserve CRO provides end-to-end clinical investigation support, from study design and site initiation to investigator training and patient recruitment. We oversee device accountability, clinical data collection, and safety reporting, and ensure efficient study close-out with clear, regulatory-ready reporting.
Whether you aim as a MD or IVD manufacturer to gain approval for your devices in the EU, US or other global markets, clinical data generation, appraisal and evaluation is critical to success today. Executing a successful clinical strategy, with the right resources and partners, to achieve regulatory approval in a cost effective manner is a challenge in today’s world.
At Qserve, we provide full scope support for medical device and IVD clinical strategy development, data collection and evaluation, with a practical approach, a focus on quality and compliance, and a very high success rate on approvals. Qserve works in full alignment with:
- ISO 14155 – Clinical investigation of medical devices
- Good Clinical Practice (GCP)
- FDA (21 CFR 812, 820) or EU MDR (Articles 62–82) depending on region
- Ethics committee / IRB approvals
- Data protection laws (HIPAA, GDPR)
Our Clinical Investigation Services
PMCF Surveys
Post-market clinical Follow-Up (PMCF) surveys have become essential for medical device manufacturers in an increasingly regulated medical world. They provide insights into the performance and safety of devices in real-world settings and ensure compliance with regulatory requirements such as the EU MDR and FDA.
PMCF Studies (Prospective & Retrospective)
We manage the complete lifecycle of PMCF studies, including protocol development, ethics submissions, site identification, investigator engagement, data collection, and final reporting. Our approach ensures your device's continued safety and performance are documented with scientific integrity.
IVD Clinical Performance Study
We design and execute IVD clinical performance studies to demonstrate the accuracy, reliability, and clinical value of your diagnostic device. For stand-alone IVD products and for companion diagnostics (CDx) connected to a drug trial. Our team ensures your study generates robust data to support regulatory approval and long-term success.
Clinical Trials
We conduct full-scope clinical studies pre- and post-market across a variety of therapeutic areas. As a leading contract research organization, we specialize in providing comprehensive services supporting the successful design, development, execution, and management of clinical trials.
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 while maintaining regulatory compliance.
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.
Let's Strengthen Your Clinical Investigations Together
Use clinical expertise to have clear project timelines, effective milestone tracking, and proactive risk management to help avoid delays and cost overruns.
Leveraging the experienced teams of Qserve allows you to streamline communication and ensures better coordination, data quality, and overall trial performance.
Get in touch with us to discuss your clinical needs and find out how Qserve can help you achieve regulatory success efficiently and effectively.
Let's Strengthen Your Clinical Investigations Together
Use clinical expertise to have clear project timelines, effective milestone tracking, and proactive risk management to help avoid delays and cost overruns.
Leveraging the experienced teams of Qserve allows you to streamline communication and ensures better coordination, data quality, and overall trial performance.
Get in touch with us to discuss your clinical needs and find out how Qserve can help you achieve regulatory success efficiently and effectively.
Relevant Blogs
Clinical data quality drives every study decision. Learn how Qserve handles structured data management and thorough UAT to prevent delays and surprises.
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Plan your clinical investigation submission in Germany: ensure process clarity and MDR-aligned documents to avoid delays or questions from the EC and BfArM
Clinical data collection is often overlooked early in development stages. Learn the benefits of early data collection and risks of delaying.