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2024/4/17 -Medicover Genetics Technology Transfer platform and software provide easy to interpret results through visualization in graphical and tubular format, instead of ...

2024/4/15 -The reporting must occur in electronic format through EUDAMED (IVDR Article 69). As this is not possible yet, this MDCG guidance outlines the safety ...

2024/4/15 -This document defines SAE reporting modalities and includes a summary tabulation reporting format. ... IVDR Articles 82-83. ... IVDR Article 76(5) AND IVDR. Article ...

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 ... 下記関連ページには、MDRとIVDRに分けて表形式で言語要件が取りまとめられています。

2024/4/11 -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.

2024/4/28 -☆ivdrスロット搭載ブルーレイレコーダーです。動作は良好です。☆日立のテレビWoooで録画した番組も、手持ちのiVDRで再生出来ました。 ... フォーマット済み☆HDD⇔iVDR ...

2024/4/15 -[LT]- NeuMoDx LDT Master Mix, DNA Instructions for Use (IVDR). more.. pdf. 470KB ... Format. File size. Language. Download · Get Adobe Reader. Other available ...

2024/4/16 -This document defines SAE reporting modalities and includes a summary tabulation reporting format. The reporting modalities and format set out in this guidance ...

2024/4/26 -NeuMoDx LDT Master Mix, RNA Instructions for Use (IVDR) - DE. more.. pdf. 2674KB ... Format. File size. Language. Download · Get Adobe Reader. Other available ...

2024/4/15 -The document also defines SAE reporting modalities and includes a summary tabulation reporting format. The document can be downloaded in our library. Source: ...