We are focused on medical devices

We specialise in medical device testing and validation, focusing particularly on instructions for use validation and material compatibility studies to ensure compliance with global regulations.

At Test Labs, we cut through the complexity of medical device testing. We recognise that the world of medical devices is filled with regulatory mazes, endless paperwork, and time-consuming processes. That’s why we’ve set out to do something different. We’re not just another testing lab; we’re innovators, scientists, and problem-solvers. We’ve designed our laboratory to allow microbiology and material sciences, supported by chemistry, to coexist under one roof, enabling us to provide highly customised solutions for your products. We provide global support for our clients throughout their medical device journey, ensuring compliance with requirements for EU CE Mark, UKCA Mark, FDA, Health Canada, and SFDA

Why We Started Test Labs

Frustrated with the status quo, we knew there had to be a smarter and better way to help medical device manufacturers navigate the intricate landscape of evaluation and validation. We wanted to create a service that was agile and responsive, that could save time and improve patient care.

So, we invested in state-of-the-art testing chambers, and fully equipped microbiology and material science areas, all designed to simulate real-life challenges. This approach has allowed us to tailor each investigation to meet precise regulatory requirements without unnecessary delays or red tape.

We are based in the UK where we provide global compliance testing services to medical device manufacturers.

What Sets Us Apart?

We started with an ambitious goal. In under a year, we had transformed into a ground-breaking, industry-recognised laboratory, maintaining extraordinarily high standards from day one: within 11 months of our inauguration, we were accredited with ISO 17025. This commitment to excellence was recognised by UKAS, who published a case study about our achievement soon after our accreditation was confirmed.

We have maintained this trajectory with our subsequent certifications by BSI for ISO 9001, ISO 45001, ISO 14001, and ISO/IEC 270011.

We constantly working on increasing our scope and gaining new certifications.

Test Labs Expands Operational Capacity with £250,000 investment in New Laboratory Facilities

On April 12, 2024, Test Labs unveiled its latest expansion initiative with the official opening of new laboratory facilities, marking a significant milestone in the company’s growth trajectory. This expansion, which entailed an investment exceeding £250,000 in state-of-the-art equipment and additional space, was made possible through securing a grant from local combined authorities.

We believe in consultative testing approach and that’s what we provide.

Understanding your needs is the cornerstone of the Test Labs experience. Our focus on customer insight ensures that we not only meet but exceed the expectations of regulators.
We offer you control and adaptability with our agile approach.

But what truly makes us stand out is our commitment to partnership.

We don’t just run tests: we work alongside you to develop customised study plans that align with your specific goals, timescales, and budgets.

We’re driven by the knowledge that what we do goes far beyond mere compliance; it’s about ensuring the highest standards of quality, safety, and reliability of medical devices.

We believe that testing is not just a checkbox to be ticked off; we see the profound impact that medical devices have on healthcare systems, as they enable healthcare professionals to deliver life-saving treatments and improve the quality of life for patients around the world.

‘Beyond Market Access’ is our commitment to patient-focused care, not just market readiness. We believe our approach and results set us apart from the rest.

August 7th 2023

Test Labs Achieves Unparalleled Status as the Only Accredited UK Laboratory for Crucial Medical Device Reprocessing

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October 17th 2022

List of Notified Bodies – Map of Europe

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April 21st 2023

Student Live Brief – Improving Disinfection Protocols for Medical Devices

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