Deviant Rhapsody > Open Mic :: Post It On the Board :: > ISO 13485 CERTIFICATION
ISO 13485 CERTIFICATION - Posted By philipwatson (philipwatson) on 3rd May 24 at 4:21am
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.