<p style="box-sizing: border-box; margin: 0px 0px 30px; font-family: system-ui, -apple-system, 'Segoe UI', Roboto, 'Helvetica Neue', 'Noto Sans', 'Liberation Sans', Arial, sans-serif, 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Noto Color Emoji'; font-size: 16px; letter-spacing: 0.1px;">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 Certification, in the EU Official Journal, with the date of &lsquo;cessation of presumption of conformity of EN ISO 13485:2012 stated as 31 March 2019.