Services available for Biocompatibility

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
ISO 10993-23 Test for Irritation

ISO 10993-23 Test for Irritation

We offer ISO 10993-23 tests to determine irritation potential of their devices without the need for animal testing.

  • 2-4 week typical lead time
  • Good Laboratory Practice GLP study
  • Biological Evaluation Plan
  • Biological Evaluation Report
  • ISO 10993-23 – test for irritation – in vitro methods
ISO 10993-5 Cytotoxicity Testing

ISO 10993-5 Cytotoxicity Testing

We offer ISO 10993-5 cytotoxicity in vitro tests which evaluate biological risks within the chemical make-up of a medical device.

  • 2-4 week typical lead time
  • Good Laboratory Practice GLP study
  • Biological Evaluation Plan
  • Biological Evaluation Report
  • ISO 10993-5 – cytotoxicity – in vitro methods
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 Biological Evaluation Plan

Medical Device Biological Evaluation Plan

We complete Biological Safety Evaluation, following ISO 10993-1 standard to address possible biological hazards and risks associated with the clinical use of your medical device.

  • 2 week typical lead time
  • ISO 10993-1 – Biological evaluation of medical devices
  • Meets the requirements of FDA / MDR
  • Provides comprehensive ISO10993 testing plan
  • 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