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VIEW MOREISO 13485 is published in 2003, that represents the requirements of a comprehensive management system for the design and manufacture of medical devices. Standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).
ISO 13485 2003 Certification 453VIEW MOREISO 13485 is published in 2003, that represents the requirements of a comprehensive management system for the design and manufacture of medical devices. Standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).