A specialized Medical Device & IVD CRO
95% of our studies are approved after just one round of EC/CA questions. Let's design a study that meets Notified Body expectations.
What is a Medical Device CRO and what do they do?
What is a Medical Device CRO and what do they do?
A Medical Device CRO (Contract Research Organization) is an organization that designs, runs, and reports clinical studies for medical devices and IVDs across all therapeutic areas. They act as a seamless extension of your team, translating complex guidelines and regulatory expectations into practical, audit-ready clinical solutions.
Does your study design meet Notified Body expectations?
Regulatory expectations for medical devices and IVDs continue to intensify. Across EU MDR/IVDR, FDA, and beyond, you must now demonstrate safety, performance, and clinical benefit across the entire product lifecycle.
Designing studies that align with ISO 14155 and GCP strains internal resources, and the varying requirements of European Competent Authorities make approval its own challenge.
Without a specialized clinical and submission strategy, you risk:
- Data gaps that delay regulatory submissions
- Protocol deviations that weaken evidence quality
- Compliance findings from Notified Bodies
- A slower, costlier path to CE marking and global market entry
MedTech CRO vs. Pharma CRO: What's the Difference?
Traditional CROs are optimized for pharmaceutical drug trials. MedTech CROs specialize exclusively in medical devices and IVDs, with deep expertise in PMCF, MDR/IVDR requirements, ISO 14155, device-specific clinical investigations, and the iterative nature of MedTech product development, areas a pharma-focused CRO isn't built to handle.
When do you need a CRO for EU MDR & IVDR?
You typically need a CRO for EU MDR & IVDR when:
- You must generate or strengthen clinical evidence to support CE marking
- Your existing data is insufficient under MDR's or IVDR's higher requirements
- You need a clinical investigation approved across multiple EU Competent Authorities
- Ongoing PMCF studies and surveys are required to maintain certification.
- Internal clinical or regulatory resources are stretched and timelines are at risk
Our Medical Device & IVD CRO 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 Studies
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, observational, pivotal, pilot or randomized studies in a all 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.
How we reduce Clinical Study Risk
Poorly planned or inadequately managed clinical programs are the leading cause of delays in MedTech. Protocol deviations, slow enrollment, inconsistent data quality, and regulatory findings don't just increase costs. They weaken the evidence value and risk rejection by Notified Bodies.
Our Approach:
Proactive Risk Management – We identify potential site bottlenecks, enrollment challenges, and data quality risks before they impact timelines.
Scientific Rigor – Every clinical objective, endpoint, and data collection method is directly linked to your regulatory and commercial goals.
Operational Agility – We utilize structured project management frameworks to keep studies efficient, compliant, and inspection-ready for regulatory audits.
How we reduce Clinical Study Risk
Poorly planned or inadequately managed clinical programs are the leading cause of delays in MedTech. Protocol deviations, slow enrollment, inconsistent data quality, and regulatory findings don't just increase costs. They weaken the evidence value and risk rejection by Notified Bodies.
Our Approach:
Proactive Risk Management – We identify potential site bottlenecks, enrollment challenges, and data quality risks before they impact timelines.
Scientific Rigor – Every clinical objective, endpoint, and data collection method is directly linked to your regulatory and commercial goals.
Operational Agility – We utilize structured project management frameworks to keep studies efficient, compliant, and inspection-ready for regulatory audits.
Why choose Qserve?
Why choose Qserve?
•Specialized in all Medical Devices (Low and High)
•Specialized in IVD Performance studies
•25 years of strong regulatory background
•Submission experts and CRAs in all major European countries
•Strong notified body background
•Full Device Lifecycle support
FAQ – Medical Device & IVD CRO Services
Still have questions? We are here to help, including with clinical strategy support.
Do you support both pre-market and post-market clinical evidence generation?
Yes. Our services span the entire product lifecycle—from initial clinical investigations for CE marking and FDA submissions to post-market clinical follow-up (PMCF), safety surveillance, and long-term registry management.
Which global regulatory standards do your clinical programs follow?
All clinical activities align with MDR (EU 2017/745), IVDR (EU 2017/746), ISO14155:2020, GCP (ICH E6), and MDCG guidance documents. We also adapt strategies to meet FDA, Health Canada, TGA, and other regional requirements for global market expansion.
Can you act as an extension of our internal clinical team?
Absolutely. We offer flexible CRO engagement models—from complete end-to-end study management to targeted consulting, staff augmentation, and clinical training—tailored to your internal capabilities and resource needs.
What does "95% approval after one round of EC/CA questions" mean?
It means that for 95% of the clinical investigations we submit, the Ethics Committee or Competent Authority approves the study after a single round of questions, rather than sending it back through multiple rounds of clarifications. Each additional review round can add weeks or months to a study start, so a high first-round approval rate is one of the clearest signals of well-designed protocols and submission-ready documentation.
Relevant Blogs
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