ISO-14971:2019 改定のポイントは以下
- リスクマネジメントプロセスには変更なし
- リスクマネジメントを実施する際の情報を充実させる
- 用語の定義の充実（「benefit」の定義追加等）
- 全体的な残存リスクの評価方法とその受容可能性の基準は、リスク管理計画において定義されなければならない。この方法は、市場に出ている医療機器および同様の装置のデータおよび文献の収集およびレビューを含むことができる。全体的な残存リスクの容認基準は、個々のリスクの容認基準とは異なる可能性がある。
- 残存リスクを開示するための複数の要件を、全体的な残存リスクが評価され、容認可能であると判断された後、1つの要件に統合。
- 医療機器を商業的に流通させる前のレビューは、リスクマネジメント計画の実施に関係している。レビューの結果は、リスクマネジメント報告書として文書化されている。製造業者は、リスクマネジメント報告書のレビューおよび更新がいつ必要となるかを決定しなければならない。
- 製造及び製造後の情報に関する条項を明確化し、再構築。収集される情報と、情報が安全性に関連すると判断された場合に取るべき措置について、より詳細に規定。
- いくつかの附属書を、並行して改訂するISO / TR 24971のガイダンスに移動。 ISO 14971の第3版の要件に関するより多くの情報と根拠を、附属書Aに記載。第2版の箇条と第3版の対応を附属書Bに示す。
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[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。”]
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