Services available for Robotic Disinfection

Medical Device Reprocessing Validation

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

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

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

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

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

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