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  • 2024/1/25 -This Joint Implementation Plan is the result of review by the MDCG including the relevant sub-groups, with input from stakeholders. It has been endorsed in.

    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 ...

    2024/4/17 -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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    4日前 -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 ...

    2024/3/4 -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 ...

    2024/1/11 -For easy reference, download this fully linked IVDR Table of Contents, which also includes the full text of the IVDR. ... format and mechanics will be different.

    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 ...

    2024/5/14 -DownloadPDF Format (opens in new window). Further Information ... (IVDR). QIAGEN ... Learn more about QIAGEN's IVDR-certified solutions on QIAGEN's IVDR support site ...

    6日前 -➢removal of 'sell-off' dates in MDR and IVDR. MDR - extension of the ... format of the FSC. Page 13.