Validation is the evaluations performed during or at the end of the product development process, aiming to ensure compliance with design requirements with adequate metrological reliability. In this sense, the analyses and tests are essential, because they ensure a final performance in accordance with regulatory and customer requirements.
Thus, the validation process seeks to ensure not only the development according to standards specifications, but also all the needs and requirements of users, as well as integrate the product correctly to the environment for which it was planned.
Currently, in the Brazilian scenario, the certification of products related to the areas of energy, health and mobility is mostly specified in ordinances of the National Institute of Metrology, Quality and Technology (Inmetro), resolutions of the National Health Surveillance Agency (ANVISA) or resolutions of the National Traffic Council (Contran).
Ordinances or resolutions establish safety and performance requirements for products for use in the Brazilian market. In this sense, the manufacturer/importer/legal representative may only market, produce or import its products if it is in accordance with the requirements set out in these documents.
In relation to medical devices, in addition to the certification process for equipment under sanitary surveillance regime, there is also the stage of registration with Anvisa. In the associated cases, the manufacturer/importer/legal representative shall only market, import and produce products that have registration. For some medical products, such as orthopedic, dental and cardiovascular implants, there is still no compulsory certification program.
The manufacturer/importer/legal representative needs to prove the safety and effectiveness to Anvisa, which, after the analysis, may or may not authorize upon publication of registration.
On the other hand, there are the cases of approval with Senatran, which are associated with the modifications and the original vehicles that circulate in the country. In this process, the manufacturer/importer/legal guardian needs to meet a number of requirements, mainly related to safety and emissions, and vehicles need to be inspected and/or tested according to standards procedures or documents issued by Contran.
Thus, in all cases tests are required to assess the performance and safety of products. In this sense, SCiTec Testing Laboratory has achieved a wide accredited scope and has become the best option for tests for certification, registration and homologation of automotive components and health products.
The services performed by SCiTec include technical assistance in regulations and standards, multidisciplinary tests in the laboratory itself, as well as the development of new testing procedures, according to the needs of the client. The laboratory is accredited by the General Accreditation Coordination of Inmetro (Cgcre) under the number CRL 0495.
