We create a safe future for MedTech
Pure Clinical Research and Development Center was established by bringing together experts from notified bodies, competent authorities, industry, and consulting to provide comprehensive support for manufacturers, importers, and distributors of medical devices. As an R&D center, we combine expertise in design, clinical research, certification, and post-market surveillance to accelerate innovation from concept to patient - without compromising on quality or compliance.
The foundations of our credibility
Responsibility Arising from the role we play
Pure Clinical was founded through the merger of MDR Regulator – an organization shaping medical device compliance across Europe – and a research team conducting clinical and preclinical projects. Every signature, every analysis, every report is the result of knowledge gained through the certification of hundreds of products. That’s why we can take responsibility for what truly matters: the safety of patients and the reliability of our clients’ processes.
Partnership Not service. Co-creation.
We collaborate with companies developing technologies that move faster than regulations. That’s why we don’t work for – we work with. We understand that a product’s success depends not only on clinical data, but also on precise regulatory interpretation, certification strategy, and execution speed. We know MDR and IVDR realities from both sides – institutional and operational – which allows us to advise before a problem arises. Our partnership is a measurable advantage: over 500 projects, 230 certifications, and clients from 37 markets.
Knowledge Built on practice, not declarations.
Our team is made up of professionals who once assessed technical documentation within notified bodies, led clinical investigations, and implemented quality systems for global manufacturers. This experience gives us a complete view of the product lifecycle – from study design to certification audit. We don’t learn through our clients’ projects — our clients benefit from our experience. That’s why we know how to streamline processes, reduce risks, and deliver documentation that gets approved the first time.
Ambition We set the direction — not just follow the rules
Pure Clinical wasn’t created to adapt to regulations - it was created to anticipate what’s next. Together with our partners across Europe and Asia, we design strategies that bring innovations to market faster — without ever compromising compliance. Each project we complete becomes a new industry benchmark. Because our goal isn’t just to guide manufacturers through MDR and IVDR — it’s to make them the reference others will follow.
Our Story
- 2020
- 2021
- 2022
- 2023
- 2024
- 2025
April 2020
Establishment of a regulatory consulting company MDR Regulator focused on medical devices and IVDs
May 2020
First client contract
September 2021
Establishment of a CRO focused on IVD clinical trials
March 2022
Implementation of ISO 14155 and ISO 20916 and GCP standards in the company
April 2022
Strategic partnership in South Korea
June 2022
Creation of the Clinical Team for MDs clinical trials
December 2022
Over 136 IVD studies completed
February 2023
Acquisition of the diagnostic laboratory
January 2024
Expansion of international cooperation
December 2024
Expansion across the EU and Asia
January 2025
Recognition as an R&D center in Poland
February 2025
Development of regulatory and global market access services with over 300 projects finished since 2020
March 2025
Securing contracts for over 50 clinical trials
September 2025
Fusion of MDR Regulator and Pure Clinical
The fusion that powers our momentum
Pure Clinical, combined with MDR Regulator, forms a unique competence center in the field of medical devices (MD), in vitro diagnostics (IVD), and pharmaceuticals. Our team combines expertise in design, pre-clinical and clinical research, preparation of technical documentation, certification, registration, and post-market surveillance.
The merger of the two organizations allowed us to build a comprehensive offer for MedTech manufacturers and innovators, providing support at every stage of the product life cycle – from concept and research to global market access.
We help manufacturers navigate the complex world of MDR and IVDR. We build technical documentation, support certification processes, and cooperate with notified bodies. We know the procedures from the inside — and we know how to guide you through them without unnecessary risks.
We design and conduct clinical studies that confirm the efficacy and safety of medical devices. We ensure data quality, methodological integrity, and compliance with MDR/IVDR requirements. Our language is facts, not declarations.
We don’t measure success by the number of reports, but by the number of MedTech innovations that reach the market because of our work. At Pure Clinical, we’ve integrated research, documentation, and certification into one predictable process — eliminating uncertainty, interpretation errors, and regulatory delays. This allows every innovation we support to reach patients faster, fully compliant, and with complete transparency at every stage.
Our approach combines scientific insight with regulatory expertise, ensuring that every technical file prepared by Pure Clinical passes notified body review without surprises. It’s the result of real experience — our experts once assessed these same documents. Today, they stand alongside manufacturers to make approval a certainty.
Every market has its own regulations - but all share the same need: a partner who understands the differences and turns them into an advantage. With experience across Europe, Asia, and the United States, we design regulatory and clinical processes that perform seamlessly on an international scale. That’s why clients from 37 countries choose Pure Clinical — not for where we are, but for how effectively we deliver.
At Pure Clinical, we take full responsibility for every stage of the process – from clinical trials to post-market surveillance. Instead of multiple vendors and fragmented decisions, we provide one clear structure of actions and communication. This gives our partners complete visibility, a single point of contact, and the confidence that every step is handled with precision and ownership.
