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 27001.
We currently perform regulatory studies in compliance with the Principles of GLP. We were thrilled to announce that we have achieved Good Laboratory Practice (GLP) certification. We have always approached certifications and accreditations pragmatically, dedicating time and resources to systems that genuinely add value for our customers. Achieving GLP certification is no exception.
We constantly working on increasing our scope and gaining new certifications.
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.
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.