medical-devices

Medical Device

Vivotecnia has demostrated experience in the preclinical evaluation of the efficacy and safety of medical device, which allows us to design studies that meet the regulatory requirements and are closely focused on the specific needs of your compounds.

We provide a range of safety evaluation and biocompatibility services dor medical devices, including studies designed in accordance with ISO 10993 and USP guidelines:

  • In vitro cytotoxicity
  • Genotoxicity
  • Irritation and skin sensitization studies
  • Hemocompatibility
  • Acute systemic toxicity
  • Systemic toxicity and tolerability studies
  • Pyrogenicity
  • Developmental and reproductive testing
  • Carcinogenicity

 

REGULATORY FRAMEWORK

ISO10993 to asess the biocompatibility of the medical device.

OUR EXPERTISE

We have succeessfully tested devices made from plastic, carbon nanotubes sheets, and with different forms, i.e, solids, creams, gels or liquids.

medical device


Please contact us to discuss your particular needs and goals.



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