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:
Food & Drug Administration FDA
United States of America
Ministry of Health Labour and Welfare MHLW
Health Care Ministry
Therapeutic Good Administration TGA
The company also has CE markings in compliance with Directive 93/42/EEC (MDD) and Regulation (EU) 2017/745 (MDR) for the sale of all medical devices in the member countries of the European Union, issued by ICIM SpA.