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Iso 13485 is now considered to be inline standard and requirement for medical devices even with global harmonization task force guidelines ghtf.
Medical devices iso 13485. What is iso 13485. Sis a leading name in iso 13485 21001 37001 27001 with expertise professionals and qualified team. Planning to go for iso 13485 certification. Because of the covid 19 crisis iso enabled free access to iso 13485 and 22 other medical device protective clothing standards see the links here.
Manage quality throughout the life cycle of a medical device with iso 13485. Iso 13485 2016 the medical device quality management system standard has been harmonized to the european medical devices directives. Iso 13485 medical devices. Mdd aimdd and ivdd.
Medical devices quality management systems requirements for regulatory purposes. Regulatory requirements are increasingly stringent throughout every step of a product s life cycle including service and delivery. 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. Iso 13485 is an international standard that specifies the quality management system requirements for organizations involved with medical devices at any stage of the product lifecycle.
Iso 13485 is an internationally recognized quality standard which states the requirements of the quality management system qms for the design and manufacture of medical devices throughout the world. This standard adopted by cen as en iso 13485 2003 ac 2007 is harmonized with respect to the european medical device directives 93 42 eec 90 385 eec and 98 79 ec. 2003 11 20 recognized registrars listing. Safety and quality are non negotiable in the medical devices industry that s why we developed iso 13485.
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