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
RDC nº 40 2015 – Requirements for medical device registration.