約1,200件1ページ目

日本語のみで絞り込む

条件を指定して検索しています。すべての条件を解除する

  • 最終更新日：1か月以内

    • IVDR's Summary of Safety and Performance | PPT - SlideShare

    1. https://www.slideshare.net
    2. Business

    2024/5/25 -Delve into IVDR's Summary of Safety and Performance for crucial insights and compliance essentials. Stay informed with our concise guide.


    EMA revises Q&A guidance on drug-device combination products

    1. https://www.raps.org
    2. News-and-Articles
    3. News-Articles

    2024/5/21 -The guidance, which is in a question-and-answer format, incorporates major changes compared to a previous version issued in November 2023. ... (IVDR) and Medical ...


    MDR - extension of the transition period - European Union

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

    2024/5/27 -➢removal of 'sell-off' dates in MDR and IVDR. MDR - extension of the transition period. Page 4. MDR – extension of transition period. Device continues to.


    Certificates and application procedure - FAMHP

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

    5日前 -Below you will find the different forms for applying for a free sale certificate in paper format. The forms are in English. If you would like a translation into ...


    The key differences between the MDR and IVDR in the EU - SlideShare

    1. https://www.slideshare.net
    2. Business

    2024/6/4 -In Vitro Diagnostic Regulation (IVDR) and its Key Points The In Vitro Diagnostic Regulation. Key Points 1.Scope and Definition 2.Risk Classification 3.


    Glossary of Medical Device, IVD, and Pharma Regulatory Terms and ...

    1. https://www.orielstat.com
    2. glossary-of-regulatory-terms

    2024/5/20 -For example, a COVID test is an IVD test. In Vitro Diagnostics Regulation (IVDR) – The In Vitro Diagnostics Regulation (2017/746) went into effect May 2022 ...


    Health Institutions that Manufacture and Use In-house in vitro ...

    PDF
    1. https://www.lenus.ie
    2. bitstream
    3. handle
    4. guide-fo...

    2024/5/24 -This guide is targeted towards health institutions in Ireland that manufacture and use in-house IVDs. The requirements of the IVDR are described here, including ...


    MedTech Europe, from diagnosis to cure - Homepage

    https://www.medtecheurope.org

    2024/5/30 -MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure. We represent Diagnostics and Medical ...

    Adopted amendments to IVDR...-Members-About us-Secretariat


    RMSシリーズ 仕様 | | アイ・オー・データ機器 I-O DATA

    1. https://www.iodata.jp
    2. hdd
    3. cartridge
    4. rms
    5. spec

    2024/6/5 -iVポケット搭載機対応カセットHDD（iVDR-S）RMSシリーズ 仕様. 仕様書印刷. 概要 ... iVDRフォーマット. 外形寸法, 80.0（W）×110.0（D）×12.7（H）mm. 質量, 約145g ...


    Machinery and technical products - Trade - European Commission

    1. https://trade.ec.europa.eu
    2. access-to-markets
    3. content

    2024/5/31 -... IVDR Regulation). This Regulation repeals with effect from 26 May 2022 ... The technical documentation to be provided is set out in point 5(c) of Annex ...