ISO 14971:2019改定点(その2)

前回に引き続きISO 14971:2019の改定について筆者の分析を紹介したい。


注)ISO 14971はQMSの構築を要求していない。もし製造業者がQMSを構築していれば、QMSのレビュの一環として実施しても良い。

リスク分析における「4.2 意図する医療機器(付属品を含む)の使用特質の明確化」が「5.2 意図された使用と合理的に予見可能な誤使用」と「5.3 安全性に関する特性の特定」に細分化された。



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