Clinical Research Designed for Regulatory Success
Full-service CRO solutions for medical devices, IVDs and digital health companies. We support your clinical strategy, execution and regulatory pathway across Europe, the UK, the US and beyond.
End-to-End Clinical Research Across Complex Technologies
We provide full-service clinical research tailored to the specific challenges of MedTech, diagnostics and digital health. Our work spans from early clinical strategy and feasibility to study execution and submission-ready documentation.
For medical devices, we support clinical evaluation, PMCF and clinical investigations aligned with MDR and FDA expectations. In the IVD space, we guide developers from RUO validation through IVDR compliance and global regulatory submissions. We also work extensively with software and AI-based technologies, supporting clinical validation for SaMD and digital health solutions under evolving regulatory frameworks, including the upcoming AI Act.
Our experience also extends to precision medicine and companion diagnostics, where clinical evidence must align both diagnostic performance and therapeutic relevance, a critical factor for successful co-development and market access.
Clinical Research as a Strategic Lever for Market Access
Clinical research is no longer just a regulatory requirement, it is a strategic function that directly impacts time-to-market, approval success and commercial viability. At MDx CRO, we design clinical strategies aligned with MDR, IVDR and FDA pathways from the outset, ensuring that every study generates the right evidence for submission and reimbursement.
By integrating regulatory thinking into study design, we help companies avoid common pitfalls such as underpowered studies, misaligned endpoints or delayed validation requirements. In practice, this means faster approvals, reduced rework and a smoother path to market, especially for complex technologies like IVDs, AI-based software and Class IIb/III medical devices.
A CRO Built for Regulatory Complexity and Innovation
MDx CRO combines deep clinical research expertise with strong regulatory capabilities, allowing us to operate as a true end-to-end partner rather than a fragmented service provider. This integration is particularly valuable in highly regulated environments where clinical evidence and regulatory strategy must evolve together.
With operations across Europe, the UK and the US, we support global clinical programs while maintaining a strong understanding of European regulatory frameworks. In many cases, companies come to us when facing complex or high-risk scenarios, such as transitioning to IVDR, validating AI-based diagnostics or preparing first-in-human studies, where standard CRO approaches are not sufficient.
Our model is built around flexibility and specialization, adapting to each technology, regulatory pathway and business objective to deliver clinical research that is both compliant and strategically effective.
Discover all our services
Clinical evaluation, PMCF and MDR/FDA-aligned studies.
Clinical validation for digital health and AI-driven solutions.
Biomarker strategies and companion diagnostics development.
Integrated clinical and regulatory roadmap design.
From RUO to IVDR compliance and global submissions.
Execution across Europe, UK, US and international sites.
Frequently Asked Questions
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What type of companies do you support?
We work with MedTech, IVD, biotech, pharma and digital health companies, from early-stage innovators to established global organizations.
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Do you support both Europe and the US?
Yes. We operate globally, with a strong footprint in Europe, the UK and the US, supporting CE marking, UK regulatory pathways and US FDA regulatory pathways.
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Can you handle both clinical research and regulatory strategy?
Yes. One of our key strengths is integrating clinical and regulatory expertise to ensure alignment from study design to submission.
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Do you work with AI and software-based medical technologies?
Absolutely. We support SaMD, AI/ML-based diagnostics and digital health platforms under MDR, IVDR and evolving AI regulatory frameworks, including the EU AI Act.
Ready to accelerate your clinical research?
Partner with a CRO that understands your technology, your regulatory pathway and your timeline.
