Services available for Class IR Instruments

Medical Device Sterilisation Validation

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
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
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
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
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
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Medical Device Reprocessing Instructions Development

We develop cleaning instructions for medical devices, whether manual or automated, to ensure your process is fully validated.

  • 2-4 week typical lead time
  • Cleaning, Disinfection & Sterilisation
  • IFU Development
  • BS EN ISO 17664-1:2021
  • ANSI/AAMI ST98/ISO 15883-5
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