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Medical device testing

Your medical device safety + our pre-clinical safety assessment services

Your medical device has the potential to significantly impact human health, but you need to first confirm its safety.  You need a partner that fully understands the regulatory requirements for entering the market or for advancing your device into development.  Whether you are looking for a safety assessment or if you simply need advice about data requirements and acceptability of existing information, then Envigo is here to help you.  Our scientists have worked with hundreds of medical devices like yours over the past 30 years to provide ethical programs of safety assessment incorporating expert reviews of existing data and in vitro and in vivo tests.

Our medical device safety assessment services include:

  • Consulting services and expert reviews
  • Material characterization by chemical analysis
  • Cytotoxicity
  • Hemocompatibility
  • Systemic toxicity
  • Local irritation
  • Intracutaneous reactivity
  • Skin sensitization
  • Genotoxicity
  • Implantation
  • USP plastics testing
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We have global team of experienced scientists dedicated to providing you with high quality scientific data and expert advice. Our in vivo testing is in AAALAC accredited or equivalent facilities supported by experienced veterinary teams. Additionally, our laboratories throughout Europe and in the USA are certified according to EN 45011, ISO 17025, GLP and GMP and offer large capacities for conducting biocompatibility assessment and analytical support.