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EME has two certifications:
- ISO 9001:2015
- ISO 13485:2016
All our products:
- Have CE brand, indicating that the product is complying with all European directives that regulate its usage; from design, manufacturing to the introduction in the market, putting into service of the product until its disposal.
- All medical devices respect the requirements of Medical Devices Directive MDD 93/42/CEE
We operate with a ISO (International Organization for Standardization) certified quality system, whose procedures are constantly applied in every step of the development and manufacturing of our products, which confirms our constant commitment in improving internal procedures, lowering costs and waste and increasing productivity.
Selling worldwide requires other certifications for each country. Countries like Korea, Indonesia, Peru, Uzbekistan, Russia and China require a certification from their own entities for selling electromedical goods. Therefore, the EME Group also received certifications from non-European institutions.