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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
    For Class A and B IVD medical devices, the STED will be prepared and submitted only at the request of a RA/CAB7 (see Figure 1). In this case, the manufacturer should be able to …

GHTF SG1 - Principles of Safety and Performance …

    https://www.imdrf.org/sites/default/files/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n011r17-conformity-to-safety-principles-medical-devices-021025.doc
    The objective of the Global Harmonization Task Force (GHTF) is to encourage convergence at the global level in the evolution of regulatory systems for medical devices in order to …

Summary Technical Documentation (STED) for Demonstrating …

    https://www.gmp-compliance.org/guidelines/gmp-guideline/summary-technical-documentation-sted-for-demonstrating-conformity-to-the-essential-principles-of-safety-and-performance-of-in-vi
    Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices Internet: …

GHTF SG1 - Summary Technical Documentation …

    http://www.ahwp.info/sites/default/files/2017-07/Final_AHWP_WG1a_F004_2013.pdf
    harmonised regulatory model for medical devices, including In Vitro Diagnostic (IVD) medical devices. The purpose of such guidance is to harmonize the documentation and …

Technical Documentation and Medical Device …

    https://www.medical-device-regulation.eu/wp-content/uploads/2020/09/White_Paper__Technical_Documentation_Web_v3.pdf
    the ‘Summary Technical Documentation (STED)’, intended to be a consistent, summarized or abridged form of the technical documentation, with sufficient detail to …

What is the STED format for medical device technical …

    https://www.massdevice.com/what-is-the-sted-format-for-medical-device-technical-documentation/
    The STED format was created by the Global Harmonization Task Force (GHTF), the precursor to the current International Medical Device Regulators Forum …

STED Explained | RegDesk | Professional …

    https://www.regdesk.co/sted-explained/
    Summary Technical Document (STED) is the proposed harmonized format used for regulatory submissions by the Global Harmonization Task Force …

MFDS guidelines STED - Kobridge

    https://kobridgeconsulting.com/mfds-guidelines-sted/
    The Summary Technical Document (STED) format for regulatory submissions is a harmonized submission format developed by the Global Harmonization Task Force …

GHTF and IMDRF - Alternative for the STED format - Elsmar …

    https://elsmar.com/elsmarqualityforum/threads/ghtf-and-imdrf-alternative-for-the-sted-format.70157/
    Further more, the new IVDR has been recently adopted by the EU parliament, is expected to be officially published in the OJ in May and will come into effect …

Emergo by UL News

    https://www.emergobyul.com/news
    Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and …



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