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The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. ISO 13485:2012 is the globally known standard for quality management systems in the medical device industry. The cookie is used to store the user consent for the cookies in the category "Performance". This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary". Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. This cookie is set by GDPR Cookie Consent plugin. ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. The cookie is used to store the user consent for the cookies in the category "Other. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". The cookie is used to store the user consent for the cookies in the category "Analytics". These cookies ensure basic functionalities and security features of the website, anonymously. Necessary cookies are absolutely essential for the website to function properly.
#ISO 13485:2012 SOFTWARE#
#ISO 13485:2012 VERIFICATION#
Additional requirements for process validation and verification activities.Additional requirements for design activities.Inclusion of risk management across all process activities.Some of the key changes to ISO 13485:2016 include:
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This standard provides the quality system architecture to demonstrate their compliance to strict regulatory requirements in these regions Requirements for regulatory purposes” is used globally by medical device manufacturers as a regulatory pathway to bring their medical devices onto some of largest worlds markets – Europe, Australia, Japan, Canada, South Korea and Brazil, etc. The ISO 13485 standard “Quality Management Systems.