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iso 13485 certification (2nd Apr 24 at 7:32am UTC)
ISO 13485:2016 is a Quality Management System standard for Medical Devices, has been harmonized with European Medical Devices Directives i.e MDD, AIMDD, and IVDD. EN ISO 13485:2012 is now updated as ISO 13485:2016, in the iso 13485 certification Official Journal, with the date of ‘cessation of presumption of conformity of EN ISO 13485:2012 stated as 31 March 2019.

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