State-of-the-art labs in Microbiology, Materials, and Chemistry.
Testing, without the friction.
Multiple disciplines in one lab means fewer delays and a faster path to market.
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.
- 4-week typical lead time
- BS EN ISO 15883-5:2021
- BS EN ISO 15883-2:2009
- BS EN ISO 17665-1:2006
- 17025 UKAS accredited
Medical Device Sterilisation Validation
We validate your medical device sterilisation instructions, which can be moist heat, low temperature hydrogen peroxide or other process.
- 4-5 week typical lead time
- Simulated use/accumulation study
- BS EN ISO 17664-1:2021
- ISO 14937:2009
- BS EN ISO 17665:2024
Medical Device Cleaning Validation
We validate your medical device cleaning instructions, as detailed in your IFU, which can be manual or automated.
- 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
Label Durability Validation
We perform assessments of medical device packaging, labels and markings to determine the robustness during the life cycle of the device.
- 2-4 week typical lead time
- Finished Product Testing
- Bulk Product/Batch Testing
- Life Cycle Testing
- Verification Testing
Accelerated Aging Testing
We perform accelerated aging testing and real time
ageing studies to determine how a products behave
under normal storage/use conditions over long periods
of time.
- 3-4 week typical lead time
- ASTM F1980 Sterile Barrier Systems & Medical Devices
- ISO 11607 Packaging for terminally sterilized medical
devices
Residual Hydrogen Peroxide Determination
We assess hydrogen peroxide residues remaining on medical devices following H2O2 sterilisation processes to assess biocompatibility and patient safety.
- 2-3 week typical lead time
- BS EN ISO 22441:2022
- BS EN ISO 109931-1:2020
- BS EN ISO 10993-17:2023
- BS EN ISO 10993-18:2020+A1:2023
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.
- 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
UV-C Technology Efficacy Testing
We assess the efficacy of UV-C light technology units and systems against the latest industry standards.
- 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
Whole Room Disinfection Systems Testing
We test a wide range of technologies including disinfection robots, fogging machines, electrostatic hand sprayers.
- 4-5 week typical lead time
- EN17272:2020 – UKAS accredited
- Cycle development / range finder tests
- Distribution test
- Biocide monitoring / safety tests