2021.06.25 Medical Device MDCG 2021-13 MDR第31条およびIVDR第28条の対象となる製造業者、欧州代理人および輸入業者以外の関係者のEUDAMEDへの登録に関する義務および関連規則に関する質問と回答
FDA 510(k) 2019.02.18 Refuse to Accept Policy for 510(k)s COPY TITLE&URL Refuse to Accept Policy for 510(k)s ]]> Tweet Share Hatena Pocket RSS feedly Pin it Guidance for the Content of Premarket Submissions for Software Contained... Previous post The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Next post
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