医療機器のサイバーセキュリティ関連情報
- 「医薬品・医療機器等安全性情報 No.373」、厚生労働省医薬・生活衛生局医薬安全対策課(令和2年6月)
- 「国際医療機器規制当局フォーラム(IMDRF)による医療機器サイバーセキュリティの原則及び実践に関するガイダンスの公表について(周知依頼)」厚生労働省医薬・生活衛生局医療機器審査管理課長(薬生機審発0513第1号)、厚生労働省医薬・生活衛生局医薬安全対策課長(薬生安発0513第1号)(令和2年5月13日)
- 「医療機器のサイバーセキュリティに関する質疑応答集(Q&A)」一般社団法人 日本医療機器産業連合会 法制委員会 医療機器プログラム対応WG(平成31年3月26日)
- 「医療機器のサイバーセキュリティの確保に関するガイダンスについて」厚生労働省医薬・生活衛生局医療機器審査管理課長(薬生機審発0724第1号)、厚生労働省医薬・生活衛生局医療機器審査管理課長(薬生安発0724第1号)(平成30年7月24日)
- 「医療機器におけるサイバーセキュリティの確保について」厚生労働省大臣官房参事官(医療機器・再生医療等製品審査管理担当)(薬食機参発0428第1号)、厚生労働省医薬食品局安全対策課長(薬食安発0428第1号)(平成27年4月28日)
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[blogcard url=https://xn--2lwu4a.jp/qms-md/ title=”QMS(手順書)ひな形 医療機器関連” ]
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