Certifications

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MESA Italia Srl complies with the latest quality standards and meets the most stringent international criteria in the production of both class IIA and IIB medical devices by constantly updating its management system in accordance with UNI EN ISO 13485:2016, UNI EN ISO 9001:2015 and MDSAP (Medical Device Single Audit Program) standards. As a result, the organisation has obtained marketing authorisation for its devices from entities in the five participating countries:

iso-13485-2016

UNI EN ISO 13485:2016

iso-9001-2015

UNI EN ISO 9001:2015

mdsap

MDSAP (Medical Device Single Audit Program)

Food & Drug Administration FDA

United States of America (USA)

Anvisa

Brazil

Ministry of Health Labour and Welfare MHLW

Japan

Health Care Ministry

Canada

Therapeutic Good Administration TGA

Australia

The company also has CE marking in accordance with Directive 93/42/EEC for the sale of all medical devices in the member countries of the European Union issued by a Notified Body (TUV South).