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En iso 13485 20169/4/2023 ![]() ![]() ![]() Once this transition period ends, the 2016 version will be formally recognised as the only acceptable revision of this standard - the 2003 version will be made obsolete by ISO. ![]() The TGA published a notification of this transition period on our website on 9 August 2016. In 2016 the International Organization for Standardization (ISO) published a new revision to ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes which would replace the previous version from 2003.ĭuring a 3-year transition period, the two versions coexisted to allow users to transition to the new 2016 revision of the standard. The 3-year transition period for ISO 13485 (full transition to the 2016 version of the standard) ends on 1 March 2019.
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