Services available for Robotic Disinfection
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
Extractables & Leachables (E&L) Testing
We offer comprehensive Extractables & Leachables (E&L) testing to identify and quantify substances, supporting your product’s biocompatibility and regulatory compliance.
- 2-4 week typical lead time
- ISO 10993-18
- USP<1663>/<1664>, USP <665>/<1665>
- Aligned with MDR and FDA guidance
- Custom Extractables Study Design
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
Medical Device Biological Evaluation Report
We produce a report which is a collective summary of all data used to assess the biocompatibility of your medical device.
- 2-3 week typical lead time
- ISO 10993-1 – Biological evaluation of medical devices
- Meets the requirements of FDA / MDR
- Provides comprehensive ISO10993 report
- Completed by in-house toxicologist (competent person)
Medical Device Biocompatibility Testing
We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.
- 4-5 week typical lead time
- Biological Evaluation Plan & Report
- In Vitro & In Vivo methods
- Extractables & Leachables (E&L) Studies
- Also testing after cleaning, disinfection & sterilization