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Ente Certificazione Macchine, accredited body by Accredia for the certification of Quality Management Systems for the international standards EN ISO 9001:2015 and EN ISO 13485:2016, extends its certification scope within the ISO 13485 standard.
Following the successful outcome of the accreditation extension process provided by Accredia, ECM extends its ISO 17021-1 accreditation to technical area 1.1.A of ISO 13485 standard.
ECM therefore expands its accreditation scope to the QMS certification of “General non-active, non-implantable medical devices”, which fall within Technical Area 1.1.A. Regarding the activities and devices included in the technical area 1.1.A of ISO 13485, please refer to the following Accredia document > https://www.accredia.it/app/uploads/2021/03/AreeTecnicheACCREDIA_gennaio2021.pdf
For information: Sales Manager ECM Medical Devices Division – Eng. Diego Stevanella email@example.com | (+39) 393 2471040