Test Labs is a GLP-certified and ISO 17025-accredited medical device testing laboratory, equipped with state-of-the-art facilities specialising in Microbiology, Material Science, and Chemistry. Our custom-built, multipurpose laboratory is designed to meet a wide range of testing needs, integrating multiple disciplines within a single facility. This cohesive setup allows us to accelerate your product's journey from development to market, ensuring efficiency and precision every step of the way.
Medical device cleaning, disinfection and sterilisation validations are a critical component to the overall reprocessing validation. It proves that the device can be cleaned, disinfected and sterilised following the manufacturer’s instructions for use (IFU). We are specialist in reprocessing validation studies and we cover global regulatory requirements.
Our facility features 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.
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 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.
