Test Labs - Medical Devices

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.

Contact Us
Our Approach

Explore our research & testing facilities

Microbiology Laboratory

Learn more

Test Chambers

Learn more

Chemistry Laboratory

Learn more

Reuseable medical device reprocessing validation

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.

Contact Us
Our Accreditations
Reprocessing Validation for Class 1r Medical Devices

Reprocessing Validation for Class 1r Medical Devices

We test your medical device reprocessing procedures, as detailed in your IFU, validating the cleaning, disinfection and sterilisation cycles.
31 related Medical device resources related to Reprocessing Validation for Class 1r Medical Devices
View resources
  • 4-week typical lead time
  • BS EN ISO 15883-5:2021
  • BS EN ISO 15883-2:2009
  • BS EN ISO 17665-1:2006
  • UKAS accredited
Learn more
Medical Device Bioburden Testing

Medical Device Bioburden Testing

Our team will determine the presence or absence of bioburden on your sterile or non- sterile medical devices.
16 related Medical device resources related to Medical Device Bioburden Testing
View resources
  • 3-4 week typical lead time
  • TYMC “Total yeast mould count”
  • TAMC “Total aerobic count”
  • Specific pathogen testing
  • ISO 11737 & ISO 11137 sterilisation method validation
Learn more
Medical Device Cleaning Validation

Medical Device Cleaning Validation

We validate your medical device cleaning instructions, as detailed in your IFU, which can be manual or automated.
37 related Medical device resources related to Medical Device Cleaning Validation
View resources
  • 4-5 week typical lead time
  • Simulated use/accumulation study
  • AAMI ST98/ISO 15883-5
  • Validated via residual analyte detection (Protein & ATP)
  • High/Low level disinfection validation to AAMI TIR-12
Learn more

Climatic test chambers

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.

Contact Us
Our Services
Highly Accelerated Life Test

Highly Accelerated Life Test

We use in-house methods and technologies to repeatedly operate devices and prototypes without human intervention to provide crucial data in accelerated time.
30 related Medical device resources related to Highly Accelerated Life Test
View resources
  • 4-6 week typical lead time
  • Medical device expected service life testing
  • Material compatibility testing
  • Basic electrical safety & essential performance testing
  • Final product & prototype testing
Learn more
UV-C Technology Efficacy Testing

UV-C Technology Efficacy Testing

We assess the efficacy of UV-C light technology units and systems against the latest industry standards.
12 related Medical device resources related to UV-C Technology Efficacy Testing
View resources
  • 2-4 week typical lead time
  • BS8628:2023 – UKAS accredited
  • 245nm UV-C, UVC LED, Far UVC (222nm)
  • Safety and Output Measurement testing
  • Simulated real-world use studies/ worst case studies
Learn more
Whole Room Disinfection Systems Testing

Whole Room Disinfection Systems Testing

We test a wide range of technologies including disinfection robots, fogging machines, electrostatic hand sprayers.
6 related Medical device resources related to Whole Room Disinfection Systems Testing
View resources
  • 4-5 week typical lead time
  • EN17272:2020 – UKAS accredited
  • Cycle development / range finder tests
  • Distribution test
  • Biocide monitoring / safety tests
Learn more

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.

Contact Us
Our Services

Contact Us:

020 3813 0969

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.

Contact Us
Our Services
Strong foundations are built with robust Quality Management Systems
Our Accreditations

A Guide to UKAS Accreditation: Everything You Need to Know

UKAS Accreditation - ‘Accreditation’ and ‘certification’ often get used interchangeably, however, they are distinctly different

Read the full blog post

Dental Product Material Compatibility Testing – Case study

Medical device safety testing includes material compatibility studies with wide range of quantitative measurements

Read the full blog post

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

In a momentous progress, Test Labs has emerged as the sole UK laboratory accredited to conduct reprocessing procedure tests

Read the full blog post