2023/10/5 -IVDR technical documentation checklist for in vitro diagnostic medical devices ; 3.4.1, Overview in tabular format of outsourced processes and name/address of ...
4日前 -... IVDR. They are drafted in collaboration with interested parties represented in the various groups and denominated by the following format: “MDCG Year-Number ...
2023/10/18 -Using an auditable structure that includes Annex II headings as a format will provide significant benefits, especially in presentation to the notified body or, ...
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 ...
2024/5/13 -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 ...
2024/6/12 -(2019). Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions. About the Blog.
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 ...
2024/1/11 -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.
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 ...
2023/10/31 -an easily-readable plain-text format, such as an 'about' file, or included on the start-up screen; c) software lacking a user interface such as middleware ...
A.著作権保護機構などが最初から備わってるので、一般的なUSBメモリとは違うものらしいです。むしろガチャポンを進化させた器機と考えられます。多分進化した故に特化し、OSのインストールとかには問題が出...