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  • 2024/1/25 -The IVDR assigns many implementation tasks to the Commission. ... IVDR in ensuring their readiness for the application of the IVDR. ... common set of elements to be ...

    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、以下の医療機器についてテンプレートが公開されました。 ・DSVG 01:心臓アブレーションデバイス・DSVG 02 ...

    2024/4/17 -IVDR is a more stringent set of regulations for IVDs in the EU and it replaces the IVDD guidelines. It determines the requirements for placing in vitro ...

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    2024/5/15 -DownloadPDF Format (opens in new window). Further Information ... (IVDR). QIAGEN ... Learn more about QIAGEN's IVDR-certified solutions on QIAGEN's IVDR support site ...

    2023/12/7 -The meeting format will be a mix of round table discussions and plenary presentations for optimised interaction. For your travel planning, the meeting will ...

    2024/5/15 -... IVDR. They are drafted in collaboration with interested parties represented in the various groups and denominated by the following format: “MDCG Year-Number ...

    2023/12/14 -This article talks about an overview of assigning IVDR codes in conformity assessment applications to ensure safety and compliance market access of products ...

    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 ...

    2023/12/4 -Regulation (EU) 2017/746 (IVDR): practical implementation of annex I in pathology ... The IVDR distinguishes between two types of IVDR ... Format: AMA, APA, MLA ...

    2024/2/26 -IVD manufacturers must comply with the general obligations set out in Article 10 of the IVDR, subject to their applicability to IVDs benefiting from a ...