Loxtay ISO 13485 Certified for Medical Device Quality Management System
ISO 13485:2016, the Medical Device Quality Management System standard, has been harmonized to the European Medical Devices Directives: MDD, AIMDD and IVDD. EN ISO 13485:2016 now replaces the previous version of the standard, EN ISO 13485:2012, in the EU Official Journal, with the date of ‘cessation of presumption of conformity’ of EN ISO 13485:2012 stated as 31 March 2019.
Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation.
Loxtay is certified for ISO 13485 and priorly for ISO 9001 to assure its manufacturing quality and safety.
