About ISO 13485 standard

Johndavid316709 Feb, 2023Education

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 EU Official Journal, with the date of ?cessation of presumption of conformity? of EN ISO 13485:2012 stated as 31 March 2019.