Clinical Investigations for Medical Devices & IVD
A stalled ethics review or a notified body query on your CIP can push a CE or FDA submission back by months. Qserve's CRO and regulatory teams run your clinical investigation end to end, from CIP to CER-ready report.
What a medical device or IVD clinical investigation service covers
What a medical device or IVD clinical investigation service covers
A medical device or IVD clinical investigation service designs, submits, executes, and reports the clinical study that generates the safety and performance evidence a CE mark or FDA submission requires. It spans Clinical Investigation Plan (CIP) development, ethics committee and competent authority submission, site management, data collection, and the final clinical investigation report.
Done properly, this work:
- Keeps the device used safely, correctly, and consistently in real clinical settings
- Produces trial data that holds up as defensible safety and performance evidence
- Stays compliant with regulatory and ethical requirements throughout the study
- Protects patient safety and data integrity across every site
- Closes out within the budget and timeline agreed at the outset
Why manufacturers use Qserve rather than a generalist CRO
Qserve combines an in-house CRO with EU MDR and IVDR regulatory consultants under one roof. A generalist CRO can run a trial; it typically can't tell you whether the resulting clinical evidence will satisfy a notified body's clinical evaluation review. Qserve's clinical and regulatory teams work from the same technical file, so study design is built to the standard your CER or PER will eventually need to defend.
This matters most for devices where the clinical evidence bar keeps moving: Class III implantables, novel combination products, and IVDs facing IVDR performance-evaluation scrutiny for the first time. Our regulatory consultants make sure it's the study a notified body will actually accept.
When you need a clinical investigation, a PMCF study, or an IVD clinical performance study
You need a clinical investigation before CE marking a Class IIb or Class III device, or ahead of an FDA IDE study, to generate pre-market safety and performance evidence. A PMCF study gathers that same evidence after market entry, closing post-market surveillance gaps under EU MDR Annex XIV Part B. An IVD clinical performance study serves the equivalent IVDR role, for stand-alone IVDs and companion diagnostics (CDx) alike.
How ISO 14155 and ISO 20916 govern your trial management
ISO 14155:2020 sets Good Clinical Practice for medical device clinical investigations: sponsor and investigator responsibilities, risk-based monitoring, and safety reporting. ISO 20916:2019 does the equivalent job for IVD clinical performance studies. Qserve's CRAs and project managers run studies to both standards, plus ICH-GCP where a trial also touches pharmaceutical GCP requirements.
Depending on where you plan to submit, your investigation also needs to satisfy the FDA IDE regulation, 21 CFR Part 812, and quality system requirements under 21 CFR 820, or the clinical investigation provisions in EU MDR Articles 62–82, alongside ethics committee/IRB approval and data protection obligations under GDPR or HIPAA.
Our Clinical Investigation 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 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 Investigation Together
Clear project timelines, defined milestones, and proactive risk management keep a clinical investigation from sliding past its target dates. Working with one team across clinical operations and regulatory strategy also means fewer handoffs, and fewer versions of the same document to reconcile.
Get in touch to discuss your clinical investigation, PMCF study, or IVD clinical performance study, and how Qserve's CRO can support it end to end.
Let's Strengthen Your Clinical Investigation Together
Clear project timelines, defined milestones, and proactive risk management keep a clinical investigation from sliding past its target dates. Working with one team across clinical operations and regulatory strategy also means fewer handoffs, and fewer versions of the same document to reconcile.
Get in touch to discuss your clinical investigation, PMCF study, or IVD clinical performance study, and how Qserve's CRO can support it end to end.
Couldn't find your question?
Can Qserve take over a clinical investigation that's already running with another CRO or in-house team?
Yes. We regularly step into an in-progress study, whether to resolve a notified body query, add capacity at a specific site, or take over full management. We start with a review of the existing CIP, safety data, and site files before making any changes.
Do you support clinical investigations outside the EU and US?
Our CRAs and project managers operate across Europe, the US, and Asia, and work with local ethics committees and competent authorities in each region a study runs in.
How long does ethics committee and competent authority approval typically take?
Timelines vary by country and device class, and a complete, well-structured CIP submission is the single biggest lever you have over them. We build realistic review windows into the study plan from the outset rather than treating approval as a fixed number of weeks.
Do you provide biostatistics and data management as part of the service?
Yes. Our biostatisticians and data managers work alongside the CRA team from study design through database lock, so the statistical analysis plan and the CIP are built to the same assumptions from day one.
Relevant Blogs
These are the 5 most common Notified Body findings during CER reviews under MDR — and what you need to address to avoid them.
.png)
What ISO 14155 requires for medical device clinical investigations: history, roles, phases, and participant protections, plus how Qserve trains teams on it.
.png)
CEP and CER are not the same document. Learn the critical difference between a Clinical Evaluation Plan and Report under EU MDR, and why it matters.