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 ...
2024/4/17 -Medicover Genetics Technology Transfer platform and software provide easy to interpret results through visualization in graphical and tubular format, instead of ...
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 ...
2024/4/15 -The reporting must occur in electronic format through EUDAMED (IVDR Article 69). As this is not possible yet, this MDCG guidance outlines the safety ...
2024/3/19 -EU IVDR regulation support for in vitro diagnostic and companion diagnostic manufacturers to comply with the in vitro diagnostic regulation.
2024/5/30 -The IVDR certificate for our class C products with identifier HX 1098896-1 and effective date 2024-05-16.
2024/3/26 -Format · Risk Management · Usability · Biological Safety · Software and Digitalization · Embedded Software · Stand-alone Software · IT in Production ...
2024/4/25 -TruSight Whole Genome offers an EU IVDR–compliant and comprehensive, DNA-to-variant call format (VCF) workflow solution for clinical WGS. This validated ...
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.
2024/4/10 -EU IVDR includes a requirement to write a Summary ... It provides key information about the device's safety and effectiveness in an easy-to-understand format.
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...