SUPERA Technology Center achieves INMETRO accreditation for Medical Equipments
Tue, January 31, 2017 03:14
SUPERA Technology Center can now perform compliance tests and reduce Certification costs up to 20% for the companies in the region.
INMETRO (National Institute of Metrology, Quality and Technology) gave SUPERA Technology Center, in Ribeirão Preto, the accreditation for laboratories to perform tests in Medical Equipments. The accreditation ensures that the Technology Center is able to perform tests in Medical Equipments within security norms and that the reports can be used by the companies to register its products in ANVISA (National Agency of Sanitary Surveillance).
The accreditation process took approximately 2 years, while many audits were performed by experts from the Institute to assure the laboratories follow the requirements. Érico Moreli, coordinator of the Technology Center, explains that INMETRO accredits laboratories as its representatives and authorizes it to provide services for testing, following national and international norms.
“Companies in the region will benefit from the accreditation with cost reduction for certifications due to logistics and easy access to experienced professionals”, says Moreli. The cost of certification is one of the challenges faced by small and medium companies in the health sector. The estimative is that the costs for these companies will decrease around 20%. The region of Ribeirão Preto has approximately 70 companies manufacturing medical equipments.
Besides high costs, the long delay for certification of medical equipments is another challenge faced by the industry. The companies will also save time by having the accredited laboratory in the region. “Some companies had to pay the costs of taking the equipments to Campinas and São Paulo. Now the accreditation of our laboratory can save time and money for them.”, explains Moreli.
The prices to access the laboratories in SUPERA Technology Center are lower than the market price. The companies associated to the Health Cluster (APL da saúde de Ribeirão Preto) get a 10% discount for certifications, and companies incubated in SUPERA Business Incubator get 20% off.
The initial accreditation conceded by INMETRO considers tests within the following norms: ABNT NBR IEC 60601-1 Equipamento Eletromédico Parte1: General requirements for basic security and essential performance and for the particular norm of electronic scalpel; and, ABNT NBR IEC 60601-2-2 Equipamento eletromédico: Parte 2-2: particular requirements for basic safety and essential performance of high frequency surgical equipments and high frequency surgical accessories.
The laboratories are operating and the plan is to request the accreditation for X ray equipments, electromagnetic compatibility norm, ultrasound equipments, equipments that utilize laser and environmental norms for equipments, products and materials.
Supera Innovation and Technology Park of Ribeirão Preto is the result of a consortium between FIPASE, University of São Paulo (USP), the City Hall of Ribeirão Preto and the Development Agency of the State of São Paulo. Located inside the Campus of USP, SUPERA Park hosts the Supera Business Incubator, Technology Center, a Health Cluster and also an ITC Cluster.
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