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STED Explained | RegDesk | Professional medical …

    https://www.regdesk.co/sted-explained/
    Dec 15, 2014. by Priya Bhutani, CEO RegDesk –. Summary Technical Document (STED) is the proposed harmonized …

Technical Documentation and Medical Device …

    https://www.bsigroup.com/contentassets/c48f4dd0aa8d4042987a2fbe72c3e086/white_paper__technical_documentation_web_v3.pdf
    the device to the NB for pre-market or post-market conformity assessment activities. With the aim of globally standardizing medical device regulatory submissions, the Global …

GHTF SG1 - Summary Technical Documentation …

    https://www.imdrf.org/sites/default/files/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n063-2011-summary-technical-documentation-ivd-safety-conformity-110317.pdf
    and Performance of IVD Medical Devices (STED) Study Group 1 Final Document GHTF/SG1/SG1/N063:2011 March 17. th, 2011 Page 8 of 30 . PART 1 – PURPOSE OF …



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