medical-devices

Medical Devices

Vivotecnia has proven experience in the preclinical evaluation of the efficacy and safety of medical devices, enabling us to design studies that fulfill regulatory requirements and focus closely on the specific needs of your product

We offer a range of medical device safety assessment and biocompatibility services, including studies designed in accordance with ISO 10993 and USP standards:

 

  • In vitro cytotoxicity
  • Genotoxicity
  • Skin irritation and sensitization studies
  • Hemocompatibility
  • Acute systemic toxicity
  • Systemic toxicity and tolerability studies
  • Pyrogenicity
  • Developmental and reproductive tests
  • Carcinogenicity
Regulatory framework
ISO10993 to assess medical device biocompatibility
Oue expertise
We have successfully tested devices made of plastic and carbon nanotube sheets, and products with diverse forms, including solids, creams, gels and liquids.

CONTACT

For more information or a formal quotation, please send us a message and we will contact you as soon as possible.



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