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What is the STED format for medical device technical …

    https://www.massdevice.com/what-is-the-sted-format-for-medical-device-technical-documentation/
    Summary Technical Documentation (STED) was developed to drive more standardization of medical device regulatory submissions across markets. STED is recognized by US, European, Canadian,...

Components of the STED or design dossier

    https://www.tga.gov.au/resources/publication/publications/what-manufacturer-needs-know-about-conformity-assessment-and-declarations-conformity-ivds/components-sted-or-design-dossier
    The TGA will accept a European Essential Requirements checklist to IVDD requirements provided it is also accompanied by a short statement to provide assurance from the …

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
    Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices. MANUFACTURER’S TECHNICAL DOCUMENTATION (Controlled Documents e.g. …

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 STED is intended for conformity assessment purposes. The manufacturer creates the STED to demonstrate to a Regulatory Authority that the subject medical device is in …

Contents of the STED for IVD - Regulatory and More

    https://regulatoryandmore.com/2020/01/01/contents-of-the-sted-for-ivd/
    The STED should include the following device descriptive information: a) the intended use of the IVD medical device. This may include: 1) what is detected 2) its …

Technical Documentation and Medical Device …

    https://www.medical-device-regulation.eu/wp-content/uploads/2020/09/White_Paper__Technical_Documentation_Web_v3.pdf
    Class IIb implantable devices (except sutures, staples, dental filings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) and class IIb active …

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.doc
    Manufacturers of all Classes of IVD medical devices are expected to demonstrate conformity of the IVD medical device to the Essential Principles of Safety and …

GHTF SG1 - Summary Technical Documentation …

    http://www.ahwp.info/sites/default/files/2017-07/Final_AHWP_WG1a_F004_2013.pdf
    The GHTF has prepared separate guidance documents on the STED for medical devices1 and the STED for IVD medical devices2. The AHWP has established the Common …

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 (GHTF). Albeit …

Medical Device Technical File and Its Structure - SimplerQMS

    https://www.simplerqms.com/medical-device-technical-file/
    A medical device technical file is a mandatory technical document that your medical devices company will submit to the concerned regulatory authorities …



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