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[blogcard url=”https://ecompliance.co.jp/SHOP/L_UE.html” title=”【VOD】医療機器ユーザビリティエンジニアリングセミナー” content=”医療機器が高度化、複雑化するにつれて、ヒューマンエラーの発生が多発しています。
ユーザビリティエンジニアリングは医療機器設計において欠かすことができない要素の一つであり、 かつ当局の関心が非常に高い分野でもあります。
2016年2月にFDAは「Applying Human Factors and Usability Engineering to Medical Devices」と呼ばれるガイダンスを発行しました。
また2007年にユーザビリティエンジニアリングの国際規格として IEC 62366:2007 が発行され、IEC 62366-1:2015 として改正されています。
本邦においても、IEC 62366-1:2015がJIS T 62366-1:2019「医療機器―第1部:ユーザビリティエンジニアリングの医療機器への適用」として発行されました。
さらに欧州では、MDD から MDRへの改正において、ユーザビリティに関する要求事項が強化されています。
医療機器設計開発においてはFDAガイダンスやIEC62366-1:2015に従い、人間工学的な要素を取り入れ、適切にユーザーインターフェースに注目したリスクマネジメントを実施する必要があります。
これまではリスクマネジメントに包含されてきましたが、今後はユーザビリティエンジニアリング(ヒューマンファクターエンジニアリング)は、独立して実施しなければなりません。
では、いったいリスクマネジメントとユーザビリティエンジニアリングでは何が異なるのでしょうか。
IEC62366-1:2015が要求するユーザビリティエンジニアリングファイルとはどういうものなのでしょうか。
またユーザビリティエンジニアリング実施のためのSOPや様式はどういうものを揃えれば良いのでしょうか。
本セミナーでは、米国FDAの要求事項およびIEC62366-1:2015の要求事項を分かり易く解説いたします。
またユーザビリティエンジニアリング実施のための手順書サンプルを配布して、SOPの作成方法についても解説いたします。”]
[blogcard url=”https://ecompliance.co.jp/SHOP/EL-030.html” title=”【セミナービデオ】医療機器ユーザビリティエンジニアリングセミナー” content=”趣旨”]
[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-154.html” title=”【IEC-62366:2015、FDA HFE/UE対応】ユーザビリティエンジニアリング規程・手順書・様式” content=”医療機器設計開発においてはIEC62366-1:2015に従い、人間工学的な要素を取り入れ、適切にリスクマネジメントを行う必要があります。
また、FDAはユーザビリティエンジニアリングに関するガイダンス
「Applying Human Factors and Usability Engineering to Medical Devices」
を2016年2月に発出し、ユーザビリティ起因の事故を防ぎ、ユーザの安全性を確保するための取組を企業に求めています。
ユーザビリティエンジニアリングは医療機器設計において欠かすことができない要素の一つであり、 かつ当局の関心が非常に高い分野でもあります。
本ひな形はIEC62366-1:2015および「Applying Human Factors and Usability Engineering to Medical Devices」に対応しています。
本ひな形をご購入いただくことで、ユーザビリティエンジニアリングに関する規制およびガイダンスに準拠したQMSを効率的に作成していただくことができます。”]
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