Test Labs - Medical Devices

As an ISO 17025-accredited Medical Device Contract Research Organisation, Test Labs houses a state-of-the-art laboratory specialising in Microbiology, Material Science, and Chemistry. Our custom-built, multipurpose laboratory is tailored to meet your diverse testing needs. Our unique setup integrates multiple testing areas within a single facility. This efficient, interdisciplinary approach is designed to expedite your product’s journey from development to market.

Explore our research & testing facilities

Microbiology Laboratory

As the lab’s central hub, the Microbiology Lab is designed for processing samples from disinfectant efficacy tests, technology efficacy tests, and environmental monitoring. We are fully equipped to conduct an expansive range of microbiological tests on bacteria, yeast, fungi, and bacterial spores.

Medical Device Reprocessing

We’ve dedicated a specialised zone solely for medical device reprocessing, equipped with calibrated devices such as autoclave and washer- disinfectors, in compliance with our UKAS accreditation. Here, we manage autoclaving processes, validate cleaning, disinfection and sterilization instructions.

Material Science Laboratory

Our material science lab is a powerhouse of diverse capabilities, from titration to formulation development and gas calibrations. Working in synergy with the Microbiology Lab, it aids in assessing the material compatibility of disinfectant products and the development of new formulations.

Reuseable medical device reprocessing validation

After establishing a robust understanding of your needs, we zero in on identifying the optimal methodology to meet your testing requirements. This could mean following established industry standards or innovatively crafting new testing protocols tailored specifically for you.

Medical device cleaning, disinfection and sterilization validations are a critical component to the overall reprocessing validation. It proves that the device can be cleaned, disinfected and sterilized following the manufacturer’s instructions for use (IFU). We’re specialist in reprocessing validation studies and we cover global regulatory requirements (FDA; EU MDR; SFDA).

Reprocessing Validation for Class 1r

Material Compatibility Assessment

Medical Device Cleaning Validation

Climatic test chambers

Our facility features three cutting-edge Test Chambers, with sizes spanning 67m3 and 12m3. Engineered with stainless steel interiors and an array of advanced sensors, these chambers offer precise control over temperature and humidity conditions. Our tech-savvy design not only allows real-time parameter monitoring via external screens but also the capability to simulate specialised environmental conditions, thereby mimicking the real-world challenges your products may face. We’re experts in medical device service life validation.

Highly Accelerated Life Test

Service Life Validation Tests

Robotic Disinfection technology tests

Material science laboratory

Our material science capabilities were purposely built to support our material compatibility studies. We have a Colour Assessment Cabinet to visually assess any potential material damages due to decontamination technologies and cleaning practices. This information is later complemented by quantitative methods with the use of calibrated equipment, such as colour meters and opacity meters.

Reusable medical device reprocessing laboratory

Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. When used on patients, reusable devices become soiled and contaminated with microorganisms. To avoid any risk of infection by a contaminated device, reusable devices undergo reprocessing, a detailed, multistep process to clean and then disinfect or sterilize them. We’ve dedicated a specialist zone solely for reprocessing validation.

Strong foundations are built with robust Quality Management Systems
April 18th 2023

A Guide to UKAS Accreditation: Everything You Need to Know

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March 24th 2023

Dental Product Material Compatibility Testing – Case study

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August 7th 2023

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

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