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  • 2024/5/14 -... IVDR. They are drafted in collaboration with interested parties represented in the various groups and denominated by the following format: “MDCG Year-Number ...

    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 ...

    2024/1/11 -If you are already doing this as part of US FDA compliance, you know the process, but the format and mechanics will be different. ... IVDR by doing their IVDR gap ...

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    2024/5/29 -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 ...

    2024/2/6 -Download the free Starter Kit, which gives you an overview of the regulatory landscape and includes the IVDR checklist in PDF and DOCX format.. Videos and e ...

    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 ...

    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.

    2024/3/26 -EU Proposal for IVDR and MDR: Step-by-Step Implementation of EUDAMED, Prior Notice Obligation for Supply Interruptions, and Transitional Arrangements for ...

    2024/6/7 -The meeting format will be a mix of round table discussions and plenary presentations for optimised interaction. For your travel planning, the meeting will ...

    2024/1/11 -Appendices A and B in SG5 N7:2012 provide a suggested format for a literature search report along with a methodology used to screen potential sources.