Medical Device & IVD Regulatory Experts
From Study Design to Market Access.
We partner with IVD manufacturers, medical device companies, and precision medicine innovators to navigate EU MDR, IVDR, FDA, and global regulatory frameworks, on time, on budget, with 100% submission success.
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What we do
We help medical technology companies move forward with confidence in complex regulatory environments.
Our work focuses on supporting teams through key stages of product development, regulatory approval, and post-market activities. Whether companies are preparing for market entry, strengthening their quality systems, or responding to regulatory changes, we provide the expertise needed to move projects forward.
Proven growth since day one
Founded in 2021, MDx has grown rapidly into Europe’s leading MedTech and IVD CRO, expanding our project portfolio every year with no slowdown in sight.
Clients who trust us
"Consistently delivered results that exceed our expectations. We consider MDx a trusted partner in advancing our MedTech product development."
R&D Director, Top 25 MedTech Manufacturer
IVD project distribution
Medical Device project distribution
Who we are
We support medical technology companies in navigating regulatory and quality requirements across global markets.
Our team works with organizations developing medical devices and in vitro diagnostics, helping them move efficiently from development to market while maintaining compliance with international regulations.
We collaborate with startups, scale-ups, and established companies that need experienced support in regulatory strategy, quality systems, and market access.
Our journey
From a founding team with decades of combined MedTech expertise to Europe's most trusted CRO, every milestone reflects our commitment to accelerating medical technology.
Services
Regulatory Strategy
Quality & Compliance
Market Access & Lifecycle Support
Request company overview
Want to learn more about our work?
Request our company overview to see our expertise, experience, and the types of projects we support.
You will receive a short presentation with an overview of our capabilities and examples of how we support medical technology companies.
Please indicate your area of interest so we can share the most relevant information.
