Services available for Compatibility
Medical Device Reprocessing Validation
We validate the full reprocessing lifecycle of your medical device, delivering the evidence you need to demonstrate regulatory compliance, ensure patient safety, and protect product longevity.
- 4-8 week typical lead time
- Custom test rigs
- Bespoke testing setups
- Cleaning, Disinfection & Sterilisation cycles
- AAMI TIR30 / ANSI/AAMI ST98:2022
R&D Medical Device Testing Support
Whether you’re refining a prototype, investigating a failure mode, or pushing the limits of what your device can do, we’re here to provide the technical testing support you need.
- 4-8 week typical lead time
- Custom test rigs
- Bespoke testing setups
- Proof-of-concept testing
- Cross-disciplinary support
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
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
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
Medical Device Material Compatibility Testing
We analyse test item materials at both sample and product level to assess process compatibility.
- Starts from 2-3 week typical lead time
- Spray tests, based on EN ISO 21530
- Soak tests, based on EN ISO 21530
- Contact tests, based on EN ISO 21530
- Wipe tests, based on BIFMA HCF 8.1-2017