Guidance for the Content of Premarket Submissions for Software Contained… 2019.02.18 Guidance for the Content of Premarket Submissions for Software Contained… Tweet Share Hatena Pocket RSS feedly Pin it FDA 510(k)関連 ISO-9001の認証を受けていても品質が向上しない訳とは Refuse to Accept Policy for 510(k)s 関連記事一覧 FDA 510(k)申請とは 2021.09.20 FDA 510(k)申請審査の厳格化とS/Wの信頼性保証について 2019.01.13 Refuse to Accept Policy for 510(k)s 2019.02.18 The 510(k) Program: Evaluating Substantial Equivale... 2019.02.18
