Medical Device

TECAM Laboratories offer studies to evaluate the biocompatibility of medical devices and biomaterials. Studies for evaluation of the biological responses relevant for the safety of medical devices and biomaterials are conducted according to the methods described in the ISO 10993 guidelines. Also the requirements for registration of such products in Brazil defined by RDC 40/2015 are also followed. Our studies are accredited by CGCRE (General Coordination of Accreditation from INMETRO) in the “Good Laboratory Practice” (GLP) and ISO 17.025 and are conducted based on a solid quality system recognized by CGCRE* (General Coordination of Accreditation from INMETRO) and ANVISA (Reblas).

*Consulte o site para o escopo acreditado

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Portfolio

  • Citotoxicity: assay that uses cell culture in contact with a device and/or extracts of a device to verify the potential of the product to cause growth inhibition or cell death.
  • Dermal sensibilization: assay to verify the potential of the product to cause sensitization or allergic reaction.
  • Irritation or Intradermal Reactivity: assays to verify the potential of the medical device to produce local reaction in the skin, mucous membrane or eye.
  • Systemic toxicity: assay performed to verify adverse effects from single or multiple exposure.
  • Genotoxicity: assays to verify the potential of the device and/or extracts of a device to cause DNA toxicity (e.g. Ames test and micronucleus test).
  • Implant test: assay to assess the macro and microscopic effect of the device after surgical implantation.
  • Subacute and subchronic toxicity: assays to verify the adverse effects from exposure after repeated doses in 28 or 90 day period.
  • Hemocompatibility: series of assays to identify and quantify blood cell alteration when in contact with the device; apply to materials that contact the blood directly or indirectly.
  • Other services:
    • Pyrogen testing: assay to detect substances that trigger a fever response when present into the animal; the most common pyrogens are pieces of bacterial cells that immune systems recognize as foreign matter.
  • Bioburden: assay performed in accordance to ISO 11737 to assess the number of bacteria living on a surface that has not been sterilized (sterilization of health products).
  • Environmental monitoring: assays performed in equipments, utensils, floors, walls, etc.

Accreditations

  • GLP
  • ANVISA

Aplications

RDC nº 40 2015 –  Requirements for medical device registration.

Contact

Rua Fábia, 59 - Vila Romana

CEP: 05051-030 - São Paulo - SP

55 11 3677 2553

contato@tecam.com.br

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