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Analyzes of Medical Devices that ALS Life Sciences São Paulo offers

We offer studies to evaluate the biocompatibility of health products (medical devices) and biomaterials, as well as to meet the RDC No. 40 of 2015, which defines the requirements for registration of these products. Our studies follow the ISO 10.993 series of standards and are accredited by CGCRE* (General Coordination of Accreditation of Inmetro) in “Good Laboratory Practices” (GLP) and ISO 17.025. Through the methods described in the ISO 10,993 series of standards, we conduct studies for the evaluation of biological responses relevant to the safety of products for health and biomaterials based on a solid quality system recognized by CGCRE* (General Coordination of Accreditation of Inmetro) and ANVISA (Reblas).

Portfolio of work

  •  Cytotoxicity: assay using cell culture to check the potential of the product to cause growth inhibition or cell death.
  • Dermal sensitization: test to verify the potential of the product to cause sensitization or contact allergy reaction.
  • Irritation or Intracutaneous Reactivity: Toxicological tests to verify the potential of the product to cause a localized reaction, be it irritation to the skin, mucosa or eye.
  • Systemic Toxicity: A toxicological test carried out on an animal model with the objective of verifying the adverse effects of single or multiple exposure.
  • Genotoxicity: Assays performed to verify the potential of the product to cause DNA toxicity (eg Ames Test and Micronucleus Test).
  • Implant Test: assay performed in an animal model with the objective of evaluating the macro and microscopic local effect after surgical implantation of the product.
  • Subacute and Subchronic Toxicity: toxicological test performed in an animal model with the objective of verifying adverse effects of exposure in repeated doses in a period of 28 or 90 days.
  • Hemocompatibility: series of tests aiming to identify and quantify changes in blood cells when in contact with the product tested; apply to materials that come in contact with the circulating blood directly or indirectly.
  • Other services:
    • Assessment of pyrogenicity for quality control of products of the metabolism of organisms, such as bacteria and fungi, which can cause fever.
    • Microbial load assessment or “Bioburden test” according to ISO 11737-1 sterilization of health products; we also carry out the environmental monitoring through tests of microbiological control of the air, equipment, utensils, floors, walls, etc.

Accreditations

  • BPL
  • CGCRE (General Coordination of Accreditation of Inmetro)
  • ANVISA

Applications

RDC nº 40, of August 26, 2015 – Provides for the registration requirements for medical products.

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