![]() Which are regulations that will replace the current directives in the 2021 and Quality system is a prerequisite for manufacturers, critical suppliers,Īuthorised representatives, importers and distributors as established in the MDRĪnd in the IVDR (EU) 2017/746 for in vitro diagnostic Medical Devices, Marking in accordance with European directives and having a conforming Remembered that the ISO 13485:2016 standard Indeed, the main objective of the ISO 13485:2016 is to favour international harmonization of requirements for Medical Devices and IVD. Moreover, the ISO 13485:2016 is increasingly in demand to be the starting point of the application of the international GMP. ![]() The ISO 13485:2016 standard ensures consistency of design, development, production, installation and supply in such a way as to make IVD and Medical Devices safe during their use. ![]() ISO 13485:2016: the best certification for medical and in vitro diagnostic Medical Devices The certification ISO 13485:2016 “Medical Devices – Quality Management Systems” identifies a standard for the Quality Management System specific for companies in the medical sector that includes aspects of the ISO 9001 standard and specific requirements for Medical Devices and in vitro diagnostic Medical Devices sector. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |