Europe’s Leading CRO for MedTech, IVD & Precision Medicine
Accelerating clinical research and regulatory success across medical devices, in-vitro diagnostics (IVDs), and precision medicine — with full-service CRO solutions tailored to your needs.
At MDx CRO, we empower medical device, IVD & precision medicine companies with expert-led clinical trials and regulatory consulting.
Our clients—ranging from global IVD manufacturers and Big Pharma to emerging MedTech startups—choose MDx for our unmatched expertise, personalized support, and 100% success rate in clinical study submissions.
With over 100 multi-country study submissions, 600+ essential study documents developed, and a global footprint across Europe, North America, and APAC, MDx CRO is the strategic partner you can trust.
End-to-End CRO Services for Regulatory & Clinical Success
Precision Support Across Key Sectors
Navigate FDA, IVDR and ISO 20916 compliance with confidence. We deliver end-to-end support—from study design and site qualification to regulatory submissions and monitoring.
Accelerate your CDx development with targeted clinical and regulatory strategies. Our expertise spans oncology, rare diseases, and multi-omic approaches—ensuring timely sample testing and regulatory alignment.
From EU MDR to global submissions, we support the development of your technical documentation, clinical investigations, risk management, and post-market clinical follow-up (PMCF) needs.
We support software-driven innovation—from SaMD classification and IEC 62304 compliance to usability engineering, risk management, and cybersecurity under MDR/IVDR and AI Act frameworks.
Ensure ISO 15189 compliance, streamline your lab-developed test (LDT) workflows, and connect laboratory data to clinical and regulatory processes for seamless integration and success.
From analytical validation to clinical utility, MDx helps you navigate the critical path of assay development. Our team supports assay design, regulatory planning, biomarker strategy, and early-phase clinical trials across therapeutic areas. We integrate scientific rigor with regulatory intelligence to streamline timelines, ensure compliance, and translate innovation into clinical outcomes.
What Makes MDx Different ?
- Preferred CRO for top 10 global IVD, MedTech, & Pharma companies
- Regulatory expertise across IVDR, MDR, FDA, UKCA, & EUDAMED
- 9.4/10 overall client satisfaction rating & 90%+ repeat business rate
- 200+ projects completed
- 500+ devices placed on the market
- 100% success in performance study submissions
- Global network across EU, US & APAC
- Led by former regulators, notified body experts, and CRO veterans
- Full digital workflows: eCRF, eTMF, biostatistics, and real-time reporting
70+ Clients Worldwide
Our Project Approach: Built for Your Success
We apply a clear, proven process to every project—ensuring precision, transparency, and results at every stage.
Listen
Align
Mobilize
Manage
Communicate
Deliver
Improve
Built Around You. Backed by Experts.
Spanish IVD Regulation 2025 – New Royal Decree Updates for IVD Manufacturers, Sponsors, and Labs
TGA guidance (Oct 2025): IVD Companion Diagnostics (CDx) Requirements in Australia
IVDR CE marking NGS: MDx Case Study with Fulgent
MDx CRO co-authors Journal of Liquid Biopsy paper on EU–US collaboration for IVDR-ready liquid biopsy validation
COMBINE Programme: Streamlining EU Combined Studies for Medicines, Devices, and Diagnostics
Your CRO Partner for Global Success
Looking for a European CRO partner that’s agile, knowledgeable, and fully equipped to guide your clinical and regulatory journey?
Whether you’re launching a Class III medical device, preparing a CDx trial, or transitioning from IVDD to IVDR, MDx CRO is here to accelerate your path to market with full-service support.
