Bescheinigungen

Mindpax is certificated with EN ISO 13485:2016

The EN ISO 13485:2016 has been published as a harmonized standard for European directives 93/42/EEC, 90/385/EEC and 98/79/EC in the Official Journal of European Union, allowing it to be used to demonstrate compliance with the requirements of these European directives.

The EN ISO 13485:2016 was published due to higher demands on the quality management system of the supplier and the manufacturer of medical devices. It contains criteria for the whole range of quality system management for medical devices.

The EN ISO 13485:2016 certificate applies to the entire management system of an organization producing or supplying medical devices and related services.