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    • IVDR 2017/746 Application Form

    1. https://www.nsai.ie
    2. uploads
    3. medical-devices
    4. I...
    1. https://www.nsai.ie
    2. uploads
    3. medical-devices
    4. I...

    2024/3/2 -Information not provided, or provided in the wrong format, may result in prolonged review time, delays, or termination of review. Signed on Behalf of the ...


    IVDR: the new era of diagnostic services - Medicover Genetics

    1. https://medicover-genetics.com
    2. Hereditary diseases
    1. https://medicover-genetics.com
    2. Hereditary diseases

    2024/4/17 -Medicover Genetics Technology Transfer platform and software provide easy to interpret results through visualization in graphical and tubular format, instead of ...


    MDCG 2024-4 Guidance on safety reporting in performance studies

    PDF
    1. https://health.ec.europa.eu
    2. document
    3. download
    PDF
    1. https://health.ec.europa.eu
    2. document
    3. download

    2024/4/15 -This document defines SAE reporting modalities and includes a summary tabulation reporting format. ... IVDR Articles 82-83. ... IVDR Article 76(5) AND IVDR. Article ...


    IVDR Technical Documentation - AKRA TEAM

    1. https://www.akrateam.com
    2. ivdr-technical-documentation
    1. https://www.akrateam.com
    2. ivdr-technical-documentation

    2024/3/4 -The technical documentation is required to be maintained throughout the device lifecycle and expected to be indexed using an aligned, structured format, as ...


    IVDR: performance studies safety reporting - MDlaw.eu

    1. https://mdlaw.eu
    2. News2
    1. https://mdlaw.eu
    2. News2

    2024/4/15 -The reporting must occur in electronic format through EUDAMED (IVDR Article 69). As this is not possible yet, this MDCG guidance outlines the safety ...


    医療機器の規格・規制の情報&リンク - TUV SUD

    1. https://www.tuvsud.com
    2. ...
    3. 医療機器関連
    1. https://www.tuvsud.com
    2. ...
    3. 医療機器関連

    2024/4/15 -テンプレートにはMDRとIVDRの両方が記載されていますが、今回は、以下の医療機器 ... 下記関連ページには、MDRとIVDRに分けて表形式で言語要件が取りまとめられています。


    Sampling of Medical Devices Under EU MDR/IVDR - Freyr Solutions

    1. https://www.freyrsolutions.com
    2. blog
    3. inside-the-eu-md...
    1. https://www.freyrsolutions.com
    2. blog
    3. inside-the-eu-md...

    2024/3/29 -This article talks about the medical device sampling and evaluation of technical documentation by NB to obtain a CE marking as per EU MDR/IVDR regulations.


    Understanding the IVDR's Summary of Safety and Performance (SSP)

    1. https://mavenprofserv.com
    2. Blog
    1. https://mavenprofserv.com
    2. Blog

    2024/4/11 -EU IVDR includes a requirement to write a Summary ... It provides key information about the device's safety and effectiveness in an easy-to-understand format.


    In vitro diagnostic medical devices (IVD) - FAMHP

    1. https://www.famhp.be
    2. ivd
    1. https://www.famhp.be
    2. ivd

    2024/2/26 -IVD manufacturers can register with · From 26 May 2022, IVDs placed on the market must comply with IVDR. · Manufacturers can register their IVDs in ...


    Download your Medical Device File creation procedure template

    1. https://www.cognidox.com
    2. medical-device-file-creation-...
    1. https://www.cognidox.com
    2. medical-device-file-creation-...

    2024/2/22 -A medical device technical file is the collection of documents that contains all the information required for ISO 13485:2106, EU MDR/IVDR and FDA QSR compliance ...