【医療機器企業リスクマネジメント】ISO 14971:2019逐条解説

医療機器企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。 
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。 

医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。 
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。 

昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。 
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。 
それでは、医療機器の安全が確保できず、また回収(改修)も減少しません。 
そのためには、リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。 

本セミナービデオでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。

お役立ち動画

https://www.youtube.com/watch?v=k7sVXpUKSzE

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/191121P.html” title=”医療機器企業におけるリスクマネジメントセミナー” content=”医療機器企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。

医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。

昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。
それでは、医療機器の安全が確保できず、また回収(改修)も減少しません。
そのためには、リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。

本セミナービデオでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-008.html” title=”【セミナービデオ】医療機器企業におけるリスクマネジメントセミナー” content=”医療機器企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。

医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。

昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。
それでは、医療機器の安全が確保できず、また回収(改修)も減少しません。
そのためには、リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。

本セミナービデオでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-026.html” title=”【ISO 14971:2019対応】リスクマネジメント規程・手順書・様式” content=”ISO14971:2019に沿った形のリスクマネジメント規程・手順書・様式です。
医療機器設計におけるリスク分析は、ISO-14971に従って実施されています。
リスクマネジメント実施のための手順や様式を整えておかなければなりません。”]

[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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