ISO 13485 Certified
The International Organization for Standardization (ISO) is an independent, non-governmental membership organization and the world’s largest developer of international standards. Encompassing 163 member countries, the ISO issues a set of globally recognized standards that provide organizations with a framework through which they can achieve certified continuous quality management in terms of their processes, products and services. The aim behind ISO is to ensure that certified members provide products and services which are safe, reliable and of good quality throughout their production and usability life span. The international standards are also strategic tools that help businesses reduce costs by minimizing waste and errors and increase productivity and efficiency.
The CE marking for medical devices is a certification awarded to manufactures who meet relevant product directives issued by the European Union. By conforming to the standards and obtaining the marking, the product would therefore comply with the European health, safety and environmental protection legislation, and hence have clearance to be sold on the market.
The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. This agency aims to protect and promote public health through the regulation and supervision of (among others) food safety, tobacco products, pharmaceuticals, vaccines, medical devices and electromagnetic radiation emitting devices (ERED). The FDA enforces laws and regulations while setting sanitation and safety requirements throughout products and services alike. The FDA is led by the Commissioner of Food and Drugs, appointed by the US President with the advice and consent of the Senate.
Mente is registered with the United States Food and Drug Administration (FDA) as a Neurological Biofeedback Medical Device classified as Class 2 (special controls) under regulation number 882.5050. This serves as proof that Mente has met the safety and functionality requirements put forth by the regulation board. The certification conforms Mente to Title 21, 807 et seq. of the United States Code of Federal Regulations. Further information can be reviewed directly on FDA’s online database.
Mente Listing Number: D214124