CEマーキング| BSI

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class="content">全世界の組織が与えられた最大の機会と直面する最大の課題はどこにあるか。</p> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">デジタルトラスト</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">専門知識</a></li> <li class="title-block"> <p class="content">プライバシー、安全、サイバーセキュリティ、信頼を大切にする、回復力のあるデジタルの未来を発展させることにより社会を構築します。</p> <a href="/ja-JP/our-expertise/digital-trust/" target="" title="デジタルトラスト" class="title">デジタルトラスト</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/our-expertise/digital-trust/artificial-intelligence/" target="" title="人工知能" class="nav-link-side">人工知能</a></li> <li><a href="/ja-JP/our-expertise/digital-trust/artificial-intelligence-adoption-and-regulation/" target="" title="人工知能（AI）経験" class="nav-link-side">人工知能（AI）経験</a></li> <li><a href="/ja-JP/our-expertise/digital-trust/cybersecurity/" target="" title="サイバーセキュリティ" class="nav-link-side">サイバーセキュリティ</a></li> <li><a href="/ja-JP/our-expertise/digital-trust/data-and-privacy/" target="" title="データとプライバシー" class="nav-link-side">データとプライバシー</a></li> <li><a href="/ja-JP/our-expertise/digital-trust/digital-risk-management/" target="" title="デジタルリスクマネジメント" class="nav-link-side">デジタルリスクマネジメント</a></li> <li><a href="/ja-JP/our-expertise/digital-trust/digital-supply-chain/" target="" title="デジタルサプライチェーン" class="nav-link-side">デジタルサプライチェーン</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">健康・安全・ウェルビーイング</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">専門知識</a></li> <li class="title-block"> <p class="content">人材を優先することは、従業員のウェルビーイングを保証し、信頼の文化を育て、未来への準備が整った人材を構築する上で役立ちます。</p> <a href="/ja-JP/our-expertise/health-safety-and-well-being/" target="" title="健康・安全・ウェルビーイング" class="title">健康・安全・ウェルビーイング</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/our-expertise/health-safety-and-well-being/cultural-change/" target="" title="文化の変化" class="nav-link-side">文化の変化</a></li> <li><a href="/ja-JP/our-expertise/health-safety-and-well-being/health-and-safety/" target="" title="健康と安全" class="nav-link-side">健康と安全</a></li> <li><a href="/ja-JP/our-expertise/health-safety-and-well-being/physical-health-and-safety/" target="" title="身体の健康と安全" class="nav-link-side">身体の健康と安全</a></li> <li><a href="/ja-JP/our-expertise/health-safety-and-well-being/psychological-well-being/" target="" title="心理的ウェルビーイング" class="nav-link-side">心理的ウェルビーイング</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">イノベーション</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">専門知識</a></li> <li class="title-block"> <p class="content">あなたが組織の発展を支援する立場にあるなら、卓越性の基準となる規格を用いて、イノベーションの無限の可能性を探ってください。</p> <a href="/ja-JP/our-expertise/innovation/" target="" title="イノベーション" class="title">イノベーション</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/our-expertise/innovation/future-of-trust/" target="" title="信頼の未来" class="nav-link-side">信頼の未来</a></li> <li><a href="/ja-JP/our-expertise/innovation/immersive-experiences/" target="" title="没入型体験" class="nav-link-side">没入型体験</a></li> <li><a href="/ja-JP/our-expertise/innovation/innovation-labs/" target="" title="イノベーションラボ" class="nav-link-side">イノベーションラボ</a></li> <li><a href="/ja-JP/our-expertise/innovation/predictive-insights/" target="" title="予測的洞察" class="nav-link-side">予測的洞察</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">品質</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">専門知識</a></li> <li class="title-block"> <p class="content">品質は信頼の基盤です。製品やサービスへの信頼を高め、成長に向けて強固な関係を築くことを可能にします。</p> <a href="/ja-JP/our-expertise/quality/" target="" title="品質" class="title">品質</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/our-expertise/quality/achieving-market-access/" target="" title="マーケットアクセスの実現" class="nav-link-side">マーケットアクセスの実現</a></li> <li><a href="/ja-JP/our-expertise/quality/business-continuity/" target="" title="事業継続" class="nav-link-side">事業継続</a></li> <li><a href="/ja-JP/our-expertise/quality/driving-business-improvement/" target="" title="業務改善の推進" class="nav-link-side">業務改善の推進</a></li> <li><a href="/ja-JP/our-expertise/quality/" target="" title="顧客満足度の向上" class="nav-link-side">顧客満足度の向上</a></li> <li><a href="/ja-JP/our-expertise/quality/quality-management/" target="" title="品質マネジメント" class="nav-link-side">品質マネジメント</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">サプライチェーン</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">専門知識</a></li> <li class="title-block"> <p class="content">サプライチェーンの複雑さが増すにつれ、それに伴うリスクと機会も増えていきます。</p> <a href="/ja-JP/our-expertise/supply-chain/" target="" title="サプライチェーン" class="title">サプライチェーン</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/our-expertise/supply-chain/a-clear-view-of-your-supply-chain/" target="" title="サプライチェーンの明確な把握" class="nav-link-side">サプライチェーンの明確な把握</a></li> <li><a href="/ja-JP/our-expertise/supply-chain/prioritizing-supplier-excellence-and-compliance/" target="" title="サプライヤーの卓越性とコンプライアンスの優先" class="nav-link-side">サプライヤーの卓越性とコンプライアンスの優先</a></li> <li><a href="/ja-JP/our-expertise/supply-chain/supply-chain-management/" target="" title="サプライチェーンマネジメント" class="nav-link-side">サプライチェーンマネジメント</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">サステナビリティ</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">専門知識</a></li> <li class="title-block"> <p class="content">持続可能な世界へ前進するために、機会を逃さず、課題を克服する。</p> <a href="/ja-JP/our-expertise/sustainability/" target="" title="サステナビリティ" class="title">サステナビリティ</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/our-expertise/sustainability/environment/" target="" title="環境" class="nav-link-side">環境</a></li> <li><a href="/ja-JP/our-expertise/sustainability/net-zero/" target="" title="ネットゼロ" class="nav-link-side">ネットゼロ</a></li> <li><a href="/ja-JP/our-expertise/sustainability/resource-security/" target="" title="資源の安全保障" class="nav-link-side">資源の安全保障</a></li> <li><a href="/ja-JP/our-expertise/sustainability/sustainable-infrastructure/" target="" title="サステナブルなインフラストラクチャー" class="nav-link-side">サステナブルなインフラストラクチャー</a></li> <li><a href="/ja-JP/our-expertise/sustainability/sustainable-supply-chain/" target="" title="サステナブルなサプライチェーン" class="nav-link-side">サステナブルなサプライチェーン</a></li> </ul> </li> </ul> </li> <li> <a href="javascript:;" title="産業" class="nav-link-side nav-first-lvl-side">産業</a> <ul class="nav-sub-lvl-side nav-sub-second-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side">メインメニュー</a></li> <li class="title-block"> <p class="content">BSIが持続可能な世界への前進の先頭に立つ産業とセクター。</p> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">建築環境</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">産業</a></li> <li class="title-block"> <p class="content">安全性、サステナビリティ、デジタルトランスフォーメーションを強化するために、建築環境における複合的な分野からのアプローチを取り入れましょう。</p> <a href="/ja-JP/industries/built-environment/" target="" title="建築環境" class="title">建築環境</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/industries/built-environment/buildings-and-construction/" target="" title="建築" class="nav-link-side">建築</a></li> <li><a href="/ja-JP/industries/built-environment/digital-trust-in-the-built-environment/" target="" title="建築環境におけるデジタルトラスト" class="nav-link-side">建築環境におけるデジタルトラスト</a></li> <li><a href="/ja-JP/industries/built-environment/quality-in-the-built-environment/" target="" title="建築環境の品質" class="nav-link-side">建築環境の品質</a></li> <li><a href="/ja-JP/industries/built-environment/sustainability-in-the-built-environment/" target="" title="建築環境のサステナビリティ" class="nav-link-side">建築環境のサステナビリティ</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">消費者、小売、食品</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">産業</a></li> <li class="title-block"> <a href="/ja-JP/industries/consumer-retail-and-food/" target="" title="消費者、小売、食品" class="title">消費者、小売、食品</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/industries/consumer-retail-and-food/quality-in-consumer-and-retail/" target="" title="消費財・小売の品質" class="nav-link-side">消費財・小売の品質</a></li> <li><a href="/ja-JP/industries/consumer-retail-and-food/supply-chain-in-consumer-and-retail/" target="" title="消費財・小売のサプライチェーン" class="nav-link-side">消費財・小売のサプライチェーン</a></li> <li><a href="/ja-JP/industries/consumer-retail-and-food/sustainability-in-consumer-and-retail/" target="" title="消費財・小売におけるサステナビリティ" class="nav-link-side">消費財・小売におけるサステナビリティ</a></li> <li><a href="/ja-JP/industries/consumer-retail-and-food/food-safety/" target="" title="食品安全" class="nav-link-side">食品安全</a></li> <li><a href="/ja-JP/industries/consumer-retail-and-food/quality-in-food/" target="" title="食品の品質" class="nav-link-side">食品の品質</a></li> <li><a href="/ja-JP/industries/consumer-retail-and-food/supply-chain-in-food/" target="" title="食品のサプライチェーン" class="nav-link-side">食品のサプライチェーン</a></li> <li><a href="/ja-JP/industries/consumer-retail-and-food/sustainability-in-food/" target="" title="食品におけるサステナビリティ" class="nav-link-side">食品におけるサステナビリティ</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">エネルギー</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">産業</a></li> <li class="title-block"> <p class="content">未来は安全で持続可能なエネルギー - 私たちは皆、それを実現するための旅をしているのです。</p> <a href="/ja-JP/industries/energy/" target="" title="エネルギー" class="title">エネルギー</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/industries/energy/digital-trust-in-energy/" target="" title="エネルギーのデジタルトラスト" class="nav-link-side">エネルギーのデジタルトラスト</a></li> <li><a href="/ja-JP/industries/energy/energy-management/" target="" title="エネルギーマネジメント" class="nav-link-side">エネルギーマネジメント</a></li> <li><a href="/ja-JP/industries/energy/innovation-in-energy/" target="" title="エネルギーの革新" class="nav-link-side">エネルギーの革新</a></li> <li><a href="/ja-JP/industries/energy/sustainability-in-energy/" target="" title="エネルギーのサステナビリティ" class="nav-link-side">エネルギーのサステナビリティ</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">政府</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">産業</a></li> <li class="title-block"> <p class="content">政策の実現、社会的障害への取り組み、規格を利用した公共サービスの効果的なガバナンスを促進します。</p> <a href="/ja-JP/industries/government/" target="" title="政府" class="title">政府</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/industries/government/health-safety-and-well-being-in-government/" target="" title="政府における健康安全とウェルビーイング" class="nav-link-side">政府における健康安全とウェルビーイング</a></li> <li><a href="/ja-JP/industries/government/innovation-in-government/" target="" title="政府のイノベーション" class="nav-link-side">政府のイノベーション</a></li> <li><a href="/ja-JP/industries/government/sustainability-in-government/" target="" title="政府のサステナビリティ" class="nav-link-side">政府のサステナビリティ</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">ヘルスケア</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">産業</a></li> <li class="title-block"> <p class="content">ライフサイエンスと医療提供におけるグローバルな課題を解決し、卓越したヘルスケアの未来を育む。</p> <a href="/ja-JP/industries/healthcare/" target="" title="ヘルスケア" class="title">ヘルスケア</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/industries/healthcare/digital-trust-in-healthcare/" target="" title="ヘルスケアのデジタルトラスト" class="nav-link-side">ヘルスケアのデジタルトラスト</a></li> <li><a href="/ja-JP/industries/healthcare/quality-in-healthcare/" target="" title="ヘルスケアの品質" class="nav-link-side">ヘルスケアの品質</a></li> <li><a href="/ja-JP/industries/healthcare/sustainability-in-healthcare/" target="" title="ヘルスケアにおけるサステナビリティ" class="nav-link-side">ヘルスケアにおけるサステナビリティ</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">情報通信技術（ICT）</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">産業</a></li> <li class="title-block"> <p class="content">ベストプラクティスを活用して、組織のインフラを強化し、データ共有を促進し、電気通信サプライチェーンレジリエンスを確保します。</p> <a href="/ja-JP/industries/ict/" target="" title="情報通信技術（ICT）" class="title">情報通信技術（ICT）</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/industries/ict/digital-trust-in-ict/" target="" title="ICTにおけるデジタルトラスト" class="nav-link-side">ICTにおけるデジタルトラスト</a></li> <li><a href="/ja-JP/industries/ict/innovation-in-ict/" target="" title="情報通信技術（ICT）のイノベーション" class="nav-link-side">情報通信技術（ICT）のイノベーション</a></li> <li><a href="/ja-JP/industries/ict/sustainability-in-ict/" target="" title="情報通信技術（ICT）のサステナビリティ" class="nav-link-side">情報通信技術（ICT）のサステナビリティ</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">製造</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">産業</a></li> <li class="title-block"> <p class="content">製造プラクティスを高め、持続可能なソリューション、品質強化、回復力のある戦略を提供することで、製造を最適化。</p> <a href="/ja-JP/industries/manufacturing/" target="" title="製造" class="title">製造</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/industries/manufacturing/health-safety-and-well-being-in-manufacturing/" target="" title="製造業の健康と安全とウェルビーイング" class="nav-link-side">製造業の健康と安全とウェルビーイング</a></li> <li><a href="/ja-JP/industries/manufacturing/sustainability-in-manufacturing/" target="" title="製造のサステナビリティ" class="nav-link-side">製造のサステナビリティ</a></li> <li><a href="/ja-JP/industries/manufacturing/supply-chain-in-manufacturing/" target="" title="製造のサプライチェーン" class="nav-link-side">製造のサプライチェーン</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">輸送・モビリティ</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">産業</a></li> <li class="title-block"> <p class="content">スマートで安全かつ持続可能な未来に向けて、輸送業界の進歩を加速させる。</p> <a href="/ja-JP/industries/transport-and-mobility/" target="" title="輸送・モビリティ" class="title">輸送・モビリティ</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/industries/transport-and-mobility/aerospace/" target="" title="航空宇宙" class="nav-link-side">航空宇宙</a></li> <li><a href="/ja-JP/industries/transport-and-mobility/automotive/" target="" title="自動車" class="nav-link-side">自動車</a></li> <li><a href="/ja-JP/industries/transport-and-mobility/digital-trust-in-transport-and-mobility/" target="" title="輸送とモビリティにおけるデジタルトラスト" class="nav-link-side">輸送とモビリティにおけるデジタルトラスト</a></li> <li><a href="/ja-JP/industries/transport-and-mobility/quality-in-transport-and-mobility/" target="" title="輸送とモビリティの品質" class="nav-link-side">輸送とモビリティの品質</a></li> <li><a href="/ja-JP/industries/transport-and-mobility/sustainability-in-transport-and-mobility/" target="" title="輸送とモビリティにおけるサステナビリティ" class="nav-link-side">輸送とモビリティにおけるサステナビリティ</a></li> </ul> </li> </ul> </li> <li> <a href="javascript:;" title="製品とサービス" class="nav-link-side nav-first-lvl-side" style="border-bottom: 1px solid #24262e;">製品とサービス</a> <ul class="nav-sub-lvl-side nav-sub-second-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side">メインメニュー</a></li> <li class="title-block"> <p class="content">BSIの製品とサービスの目的は、貴組織が前進を加速させ、機会を広げ、変化を起こすことができるように支援することです。</p> </li> <li> <a href="/ja-JP/products-and-services/how-we-work-with-our-clients/" target="" title="お客様との協働" class="nav-link-side">お客様との協働</a> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">主な規格</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">製品とサービス</a></li> <li class="title-block"> <span class="title" style="border-bottom:1px solid transparent !important">主な規格</span> <span class="nav-line"></span> </li> <li><a href="/ja-JP/products-and-services/standards/iso-9001-quality-management-systems/" target="" title="ISO 9001 - 品質マネジメントシステム" class="nav-link-side">ISO 9001 - 品質マネジメントシステム</a></li> <li><a href="/ja-JP/products-and-services/standards/ems-iso-14001-environmental-management-system/" target="" title="ISO 14001 - 環境マネジメントシステム（EMS）" class="nav-link-side">ISO 14001 - 環境マネジメントシステム（EMS）</a></li> <li><a href="/ja-JP/products-and-services/standards/iso-iec-27001-information-security-management-system/" target="" title="ISO/IEC 27001 - 情報セキュリティマネジメントシステム" class="nav-link-side">ISO/IEC 27001 - 情報セキュリティマネジメントシステム</a></li> <li><a href="/ja-JP/products-and-services/standards/iso-45001-occupational-health-and-safety/" target="" title="ISO 45001- 労働安全衛生" class="nav-link-side">ISO 45001- 労働安全衛生</a></li> <li><a href="/ja-JP/products-and-services/standards/iso-42001-ai-management-system/" target="" title="ISO/IEC 42001 - AIマネジメントシステム" class="nav-link-side">ISO/IEC 42001 - AIマネジメントシステム</a></li> <li><a href="/ja-JP/products-and-services/standards/iso-13485-quality-management-system/" target="" title="ISO 13485 - 品質マネジメントシステム" class="nav-link-side">ISO 13485 - 品質マネジメントシステム</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">規格サービス</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">製品とサービス</a></li> <li class="title-block"> <p class="content">購買基準に直接アクセスし、お客様とお客様の組織に卓越性に向けた青写真を提供します。</p> <a href="/ja-JP/products-and-services/standards-services/" target="" title="規格サービス" class="title">規格サービス</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/products-and-services/standards-services/bsi-knowledge-subscription/" target="" title="BSIナレッジサブスクリプション" class="nav-link-side">BSIナレッジサブスクリプション</a></li> <li><a href="/ja-JP/products-and-services/standards-services/standards-development/" target="" title="標準の開発" class="nav-link-side">標準の開発</a></li> <li><a href="/ja-JP/products-and-services/standards-services/connecting-experts/" target="" title="専門家をつなぐ" class="nav-link-side">専門家をつなぐ</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">アセスメントと認証</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">製品とサービス</a></li> <li class="title-block"> <p class="content">私たちは、あなたの組織の認証と監査を行い、製品やプロセスの品質と安全性を証明することができます。</p> <a href="/ja-JP/products-and-services/assessment-and-certification/" target="" title="アセスメントと認証" class="title">アセスメントと認証</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/products-and-services/assessment-and-certification/system-certification/" target="" title="システム認証" class="nav-link-side">システム認証</a></li> <li><a href="/ja-JP/products-and-services/assessment-and-certification/product-testing-certification/" target="" title="製品認証" class="nav-link-side">製品認証</a></li> <li><a href="/ja-JP/products-and-services/assessment-and-certification/validation-and-verification/" target="" title="検証と妥当性確認" class="nav-link-side">検証と妥当性確認</a></li> <li><a href="/ja-JP/products-and-services/internal-audit/" target="" title="内部監査" class="nav-link-side">内部監査</a></li> <li><a href="/ja-JP/products-and-services/supplier-audit/" target="" title="サプライヤー監査" class="nav-link-side">サプライヤー監査</a></li> <li><a href="/ja-JP/products-and-services/assessment-and-certification/kitemark/" target="" title="Kitemark" class="nav-link-side">Kitemark</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">コンサルティング</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">製品とサービス</a></li> <li class="title-block"> <a href="/ja-JP/products-and-services/consulting/" target="" title="コンサルティング" class="title">コンサルティング</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/products-and-services/consulting/business-continuity-consulting/" target="" title="事業継続" class="nav-link-side">事業継続</a></li> <li><a href="/ja-JP/products-and-services/consulting/digital-compliance/" target="" title="デジタルコンプライアンス" class="nav-link-side">デジタルコンプライアンス</a></li> <li><a href="/ja-JP/products-and-services/consulting/environmental-compliance/" target="" title="環境コンプライアンス" class="nav-link-side">環境コンプライアンス</a></li> <li><a href="/ja-JP/products-and-services/consulting/environmental-risk-and-resilience-consulting/" target="" title="環境リスクとレジリエンス" class="nav-link-side">環境リスクとレジリエンス</a></li> <li><a href="/ja-JP/products-and-services/consulting/health-well-being-consulting/" target="" title="健康＆ウェルビーイング" class="nav-link-side">健康＆ウェルビーイング</a></li> <li><a href="/ja-JP/products-and-services/consulting/loss-prevention-and-digital-resilience/" target="" title="損失防止とデジタルレジリエンス" class="nav-link-side">損失防止とデジタルレジリエンス</a></li> <li><a href="/ja-JP/products-and-services/consulting/risk-mitigation-and-threat-transparency/" target="" title="リスク軽減と脅威の透明性" class="nav-link-side">リスク軽減と脅威の透明性</a></li> <li><a href="/ja-JP/products-and-services/consulting/safety-consulting/" target="" title="安全性" class="nav-link-side">安全性</a></li> <li><a href="/ja-JP/products-and-services/consulting/supply-chain-security-risk/" target="" title="サプライチェーンのセキュリティリスク" class="nav-link-side">サプライチェーンのセキュリティリスク</a></li> <li><a href="/ja-JP/products-and-services/consulting/sustainability-consulting/" target="" title="サステナビリティ" class="nav-link-side">サステナビリティ</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">医療機器</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">製品とサービス</a></li> <li class="title-block"> <p class="content">持続可能な方法で医療技術のタイムリーなマーケットアクセスを支援する一方で、患者の安全を確保しましょう。</p> <a href="/ja-JP/products-and-services/medical-devices/" target="" title="医療機器" class="title">医療機器</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/products-and-services/medical-devices/active-medical-devices/" target="" title="能動医療機器" class="nav-link-side">能動医療機器</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/ai-in-medical-devices/" target="" title="医療機器におけるAI" class="nav-link-side">医療機器におけるAI</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/aimd/" target="" title="能動埋め込み型医療機器（AIMD）" class="nav-link-side">能動埋め込み型医療機器（AIMD）</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/ce-marking/" target="" title="CEマーキング" class="nav-link-side">CEマーキング</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/general-medical-devices/" target="" title="一般医療機器" class="nav-link-side">一般医療機器</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/mdsap/" target="" title="医療機器単一調査プログラム（MDSAP）" class="nav-link-side">医療機器単一調査プログラム（MDSAP）</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/medical-device-regulation-mdr/" target="" title="欧州医療機器規則（MDR）" class="nav-link-side">欧州医療機器規則（MDR）</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/ivd/" target="" title="体外診断用医療機器（IVD）" class="nav-link-side">体外診断用医療機器（IVD）</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/ivdr/" target="" title="体外診断用医療機器規制（IVDR）" class="nav-link-side">体外診断用医療機器規制（IVDR）</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/medicinal-and-biologics/" target="" title="医薬品・生物製剤" class="nav-link-side">医薬品・生物製剤</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/microbiology/" target="" title="微生物学" class="nav-link-side">微生物学</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/orthodental/" target="" title="歯科矯正" class="nav-link-side">歯科矯正</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/pmd-act/" target="" title="医薬品医療機器等法（PMD Act）" class="nav-link-side">医薬品医療機器等法（PMD Act）</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/ukca-marking/" target="" title="英国基準適合評価（UKCA）マーク" class="nav-link-side">英国基準適合評価（UKCA）マーク</a></li> <li><a href="/ja-JP/products-and-services/medical-devices/vascular-medical-devices/" target="" title="血管用医療機器" class="nav-link-side">血管用医療機器</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">研修と資格</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">製品とサービス</a></li> <li class="title-block"> <p class="content">教育訓練の一環としてご利用いただける各種研修及び資格制度をご用意しております。</p> <a href="/ja-JP/products-and-services/training-courses-and-qualifications/" target="" title="研修と資格" class="title">研修と資格</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/products-and-services/training-courses-and-qualifications/training-courses-results/" target="" title="すべての研修と資格を検索" class="nav-link-side">すべての研修と資格を検索</a></li> <li><a href="/ja-JP/products-and-services/training-courses-and-qualifications/iso-iec-42001-training-courses/" target="" title="AI（人工知能）マネジメント研修" class="nav-link-side">AI（人工知能）マネジメント研修</a></li> <li><a href="/ja-JP/products-and-services/training-courses-and-qualifications/iso-19650-and-bim-training-online-courses/" target="" title="BIM研修" class="nav-link-side">BIM研修</a></li> <li><a href="/ja-JP/products-and-services/training-courses-and-qualifications/iso-45001-training-courses/" target="" title="労働安全衛生マネジメント研修" class="nav-link-side">労働安全衛生マネジメント研修</a></li> <li><a href="/ja-JP/products-and-services/training-courses-and-qualifications/iso-iec-27001-training-courses/" target="" title="情報セキュリティマネジメント研修" class="nav-link-side">情報セキュリティマネジメント研修</a></li> <li><a href="/ja-JP/products-and-services/training-courses-and-qualifications/iso-13485-training-courses/" target="" title="医療機器品質マネジメント研修" class="nav-link-side">医療機器品質マネジメント研修</a></li> <li><a href="/ja-JP/products-and-services/training-courses-and-qualifications/iso-9001-training-courses/" target="" title="品質マネジメント研修" class="nav-link-side">品質マネジメント研修</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">ツール</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">製品とサービス</a></li> <li class="title-block"> <p class="content">プロセス改善、強力な洞察、規制の更新を通じて、企業をサポートするソフトウェアとプラットフォーム。</p> <span class="title" style="border-bottom:1px solid transparent !important">ツール</span> <span class="nav-line"></span> </li> <li><a href="/ja-JP/products-and-services/bsi-connect/" target="" title="BSI Connect" class="nav-link-side">BSI Connect</a></li> <li><a href="/ja-JP/products-and-services/bsi-connect/connect-portal/" target="" title="BSI Connect Portal" class="nav-link-side">BSI Connect Portal</a></li> <li><a href="/ja-JP/products-and-services/bsi-connect/connect-plus/" target="" title="Connect Plus" class="nav-link-side">Connect Plus</a></li> <li><a href="/ja-JP/products-and-services/bsi-connect/connect-climate/" target="" title="Connect Climate" class="nav-link-side">Connect Climate</a></li> <li><a href="/ja-JP/products-and-services/bsi-connect/connect-screen/" target="" title="Connect Screen" class="nav-link-side">Connect Screen</a></li> <li><a href="/ja-JP/products-and-services/compliance-navigator/" target="" title="コンプライアンス・ナビゲーター" class="nav-link-side">コンプライアンス・ナビゲーター</a></li> <li><a href="/ja-JP/products-and-services/identify/" target="" title="BSI Identify" class="nav-link-side">BSI Identify</a></li> </ul> </li> </ul> </li> <li> <a href="javascript:;" title="洞察とメディア" class="nav-link-side nav-first-lvl-side">洞察とメディア</a> <ul class="nav-sub-lvl-side nav-sub-second-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side">メインメニュー</a></li> <li class="title-block"> <p class="content">思考を形作る洞察と、私たちが進歩の加速をお手伝いした分野についての情報をご紹介。</p> </li> <li> <a href="/ja-JP/insights-and-media/" target="" title="洞察とメディア" class="nav-link-side">洞察とメディア</a> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">洞察</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">洞察とメディア</a></li> <li class="title-block"> <a href="/ja-JP/insights-and-media/Search?searchText=*&filterBy=insights" target="" title="洞察" class="title">洞察</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/insights-and-media/Search?searchText=*&filterBy=all&pagetypes=casestudies" target="" title="ケーススタディ" class="nav-link-side">ケーススタディ</a></li> <li><a href="/ja-JP/insights-and-media/Search?searchText=*&filterBy=all&pagetypes=whitepapers" target="" title="ホワイトペーパー" class="nav-link-side">ホワイトペーパー</a></li> <li><a href="/ja-JP/insights-and-media/Search?searchText=*&filterBy=all&pagetypes=blogs" target="" title="ブログ" class="nav-link-side">ブログ</a></li> <li><a href="/ja-JP/insights-and-media/Search?searchText=*&filterBy=all&pagetypes=brochures" target="" title="パンフレット" class="nav-link-side">パンフレット</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">メディア</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">洞察とメディア</a></li> <li class="title-block"> <a href="/ja-JP/insights-and-media/Search?searchText=*&filterBy=media" target="" title="メディア" class="title">メディア</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/insights-and-media/Search?searchText=*&filterBy=eventscalendar&pagetypes=news&sortBy=2" target="" title="イベント" class="nav-link-side">イベント</a></li> <li><a href="/ja-JP/insights-and-media/Search?searchText=*&filterBy=all&pagetypes=webinars" target="" title="ウェビナー" class="nav-link-side">ウェビナー</a></li> <li><a href="/ja-JP/insights-and-media/Search?searchText=*&filterBy=all&pagetypes=news" target="" title="ニュース" class="nav-link-side">ニュース</a></li> <li><a href="/ja-JP/legal/bsi-logos/" target="" title="ブランドアセット" class="nav-link-side">ブランドアセット</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">キャンペーン</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">洞察とメディア</a></li> <li class="title-block"> <span class="title" style="border-bottom:1px solid transparent !important">キャンペーン</span> <span class="nav-line"></span> </li> <li><a href="/ja-JP/insights-and-media/campaigns/thirst-for-change/" target="" title="変革への渇望" class="nav-link-side">変革への渇望</a></li> </ul> </li> </ul> </li> <li> <a href="javascript:;" title="BSIについて" class="nav-link-side nav-first-lvl-side">BSIについて</a> <ul class="nav-sub-lvl-side nav-sub-second-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side">メインメニュー</a></li> <li class="title-block"> <p class="content">社会に良い影響を与える。それが私たちの存在意義です。私たちが皆様とどのように連携し、社会最大の課題へのソリューションを実現しているかをご覧ください。</p> </li> <li> <a href="/ja-JP/about-bsi/awards-and-recognition/" target="" title="賞と表彰" class="nav-link-side">賞と表彰</a> </li> <li> <a href="/ja-JP/about-bsi/" target="" title="BSIについてもっと詳しく" class="nav-link-side">BSIについてもっと詳しく</a> </li> <li> <a href="/ja-JP/about-bsi/careers/" target="" title="キャリア" class="nav-link-side">キャリア</a> </li> <li> <a href="/ja-JP/about-bsi/certification-business-policy/" target="" title="認証に関するビジネスポリシー" class="nav-link-side">認証に関するビジネスポリシー</a> </li> <li> <a href="/ja-JP/about-bsi/compliance-and-ethics-in-bsi/" target="" title="BSIのコンプライアンスと倫理" class="nav-link-side">BSIのコンプライアンスと倫理</a> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">ガバナンス</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">BSIについて</a></li> <li class="title-block"> <p class="content">貴組織のPartner in Progressとして、持続可能な世界への歩みを加速させます。お客様やステークホルダーの皆様と連携し、重要な課題に対して有効なソリューションを提供します。</p> <a href="/ja-JP/about-bsi/governance/" target="" title="ガバナンス" class="title">ガバナンス</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/about-bsi/governance/" target="" title="BSIガバナンス" class="nav-link-side">BSIガバナンス</a></li> <li><a href="/ja-JP/about-bsi/our-people/bsi-board/" target="" title="BSIボード" class="nav-link-side">BSIボード</a></li> <li><a href="/ja-JP/about-bsi/our-people/bsi-chairman/" target="" title="BSI会長" class="nav-link-side">BSI会長</a></li> <li><a href="/ja-JP/about-bsi/our-people/senior-independent-director/" target="" title="社外取締役" class="nav-link-side">社外取締役</a></li> <li><a href="/ja-JP/about-bsi/our-people/chief-executive-officer/" target="" title="CEO" class="nav-link-side">CEO</a></li> <li><a href="/ja-JP/about-bsi/our-people/board-committees/" target="" title="委員会" class="nav-link-side">委員会</a></li> <li><a href="/ja-JP/about-bsi/our-people/board-committees/" target="" title="監査・リスク委員会" class="nav-link-side">監査・リスク委員会</a></li> <li><a href="/ja-JP/about-bsi/our-people/board-committees/" target="" title="報酬委員会" class="nav-link-side">報酬委員会</a></li> <li><a href="/ja-JP/about-bsi/our-people/board-committees/" target="" title="指名委員会" class="nav-link-side">指名委員会</a></li> <li><a href="/ja-JP/about-bsi/our-people/board-committees/" target="" title="サステナビリティ委員会" class="nav-link-side">サステナビリティ委員会</a></li> <li><a href="/ja-JP/about-bsi/our-people/board-committees/" target="" title="標準政策＆戦略委員会（SPSC）" class="nav-link-side">標準政策＆戦略委員会（SPSC）</a></li> <li><a href="/ja-JP/about-bsi/bsi-royal-charter/" target="" title="BSI王室認可" class="nav-link-side">BSI王室認可</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">グループの財務実績</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">BSIについて</a></li> <li class="title-block"> <a href="/ja-JP/about-bsi/bsi-group-financial-performance/" target="" title="グループの財務実績" class="title">グループの財務実績</a> <span class="nav-line"></span> </li> <li><a href="/ja-JP/about-bsi/bsi-group-financial-performance/" target="" title="年次報告書" class="nav-link-side">年次報告書</a></li> <li><a href="/en-GB/about-bsi/annual-general-meeting/" target="_blank" title="年次総会" class="nav-link-side">年次総会</a></li> <li><a href="/siteassets/pdf/en/about-us/230615_tax-strategy_revised_dmwm_final_board-approved-2.pdf" target="_blank" title="BSIの英国の税務戦略" class="nav-link-side">BSIの英国の税務戦略</a></li> <li><a href="/siteassets/pdf/en/about-us/bsi-ghg-emissions-calculation-methodology-final.pdf" target="_blank" title="BSIの温室効果ガス（GHG）排出量報告フレームワーク" class="nav-link-side">BSIの温室効果ガス（GHG）排出量報告フレームワーク</a></li> <li><a href="/siteassets/pdf/en/about-us/bsi-standards-makers-feedback-policy.pdf" target="_blank" title="BSI温室効果ガス（GHG）限定的保証意見書－ KPMG" class="nav-link-side">BSI温室効果ガス（GHG）限定的保証意見書－ KPMG</a></li> </ul> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">規約等</a> <ul class="nav-sub-lvl-side nav-sub-third-container"> <li class="mob-only"><a href="javascript:;" class="nav-link-side nav-back-side" tabindex="0">BSIについて</a></li> <li class="title-block"> <span class="title" style="border-bottom:1px solid transparent !important">規約等</span> <span class="nav-line"></span> </li> <li><a 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class="label breadcrumbs-link" title="CEマーキング">CEマーキング</a></li> </ol> </div> </nav> <section id="" class="content content-split content-wide content-image content-image-right bg-bsi-coral-20 heroes-image-mask heroes-image-mask-large" data-component="hero-products-and-services-block"> <div class="container"> <div class="content-inner"> <div class="content-column"> <picture class="content-image-wrapper"> <source media="(min-width: 960px)" srcset="/siteassets/images/16-9-lnd/gl-gmkt-brand-hc-mt-mp-021426756188-1123-img.jpg?imwidth=1081, /siteassets/images/16-9-lnd/gl-gmkt-brand-hc-mt-mp-021426756188-1123-img.jpg?imwidth=1081&imdensity=2 2x" /> <source srcset="/siteassets/images/16-9-lnd/gl-gmkt-brand-hc-mt-mp-021426756188-1123-img.jpg?imwidth=375, /siteassets/images/16-9-lnd/gl-gmkt-brand-hc-mt-mp-021426756188-1123-img.jpg?imwidth=375" /> <img src="/siteassets/images/16-9-lnd/gl-gmkt-brand-hc-mt-mp-021426756188-1123-img.jpg" alt="CEマーキング-医療機器" width="704" height="396"> </picture> </div> <div class="content-column"> <span class="badge">規制サービス</span> <h1 class="title">CEマーキング</h1> <p class="sub-heading-s content-column-text"> </p> </div> </div> </div> </section> <section id="" class="section-layout-standard content content-split content-wide content-2-columns bg-bsi-white" data-component="content-block"> <div class="container"> <div class="content-inner"> <div class="content-column"> <h2 class="title heading-l">患者の安全性と機器のパフォーマンスに関する厳しい要求事項を考えると、欧州市場への参入は製品の市場投入を遅らせる可能性のある課題をもたらすと言えます</h2> <div class="sub-heading-s">業界を理解し、製品を市場に投入する準備を審査・確認する経験を持つノーティファイドボディと協力することが極めて重要です。</div> <div class="body-m content-body"><p>BSI The Netherlands（2797）は、MDRとIVDRのフルスコープ指定を達成した主要なノーティファイドボディです。弊社では、お客様の医療機器を市場に送り出すための効率的なパスウェイを提供する柔軟な製品審査サービスを提供することで、欧州規制に対する適合性を査定するための審査を行います。<br /><br />CEマーキングとは、製品が関連するすべての欧州医療機器規則の一般要求事項（GSPR）を満たしているという医療機器メーカーの主張であり、欧州連合（EU）内で医療機器を市場に投入するための法的要求事項です。</p></div> </div> <div class="content-column"> <h3 class="title heading-l">どの要求事項を満たす必要があるかを理解するには、デバイスを分類し、製品に適した適合性評価ルートを特定する必要があります</h3> <div class="sub-heading-s">これは、適合性を証明するために必要な活動を規定するものです。当社は、お客様が選んだルートが適切かどうかを確認します。</div> <div class="body-m content-body"><p>当社は、選択されたルートに対して最も効率的な審査プロセスを実施するために、お客様と協力します。当社の信頼できる審査プロセスにより、英国適合性評価（CE）マークプロジェクトの計画に信頼性と自信を得ることができます。<br /><br />注：当社のサービスは、EU証明書の発行や一定の営業日数以内の発行を保証するものではありませんが、肯定的または否定的な勧告のいずれかで審査プロセスを完了することを基本としています。動物組織誘導体、ヒト組織誘導体または医薬品を使用する機器には、CE認証は与えられません。</p></div> </div> </div> </div> </section> <section id="" class="section-feature section-feature-2 section-layout-standard section-layout-standard-2 bg-bsi-white" data-component="feature-block"> <div class="section-layout-standard-inner container"> <div class="col col-floater"> <span class="badge">規制サービス</span> <h2 class="title heading-l">お客様をサポートするその他のリソース</h2> <p class="sub-heading-s mb0"></p> </div> <div class="col feature-container"> <span class="feature-list"> <span class="feature-item"> <a class="feature feature-link" href="/siteassets/pdf/en/insights-and-media/insights/brochures/bsi-md-excellence-pathways-en-gb.pdf" title="詳細はこちら" target="_blank"> <div class="feature-content"> <span class="badge">リソース</span> <h3 class="title heading-xs">当社の卓越したパスウェイ</h3> <p class="body-m my0">コンプライアンスに準拠した安全なデバイスをグローバル市場に投入するための、経験豊富で効率的なルートをご紹介します。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item"> <a class="feature feature-link" href="/siteassets/pdf/en/insights-and-media/insights/brochures/bsi-md-mdr-ivdr-app-and-cert-process-uk-en.pdf" title="詳細はこちら" target="_blank"> <div class="feature-content"> <span class="badge">リソース</span> <h3 class="title heading-xs">CEマーキングガイド</h3> <p class="body-m my0">医療機器の認証プロセスおよびIVD規制。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item"> <a class="feature feature-link" href="/ja-JP/insights-and-media/insights/brochures/mdr-transition-timelines-extended-faqs/" title="詳細はこちら" target="_top"> <div class="feature-content"> <span class="badge">リソース</span> <h3 class="title heading-xs">MDR移行ガイダンス</h3> <p class="body-m my0">改正規則（EU）2023/607を先取りします。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> </span> </div> </div> </section> <section id="" class="section-layout-standard section-layout-standard-2 bg-bsi-white" data-component="list-all-variants-block"> <div class="section-layout-standard-inner container"> <div class="col col-floater"> <h2 class="title">英国適合性評価（CE）マーク取得のためにBSIに依頼する理由</h2> <p class="sub-heading-s">フルスコープノーティファイドボディ。</p> </div> <ul class="list"> <li class="list-item"> <p>一般医療機器</p> </li> <li class="list-item"> <p>能動埋め込み型医療機器</p> </li> <li class="list-item"> <p>体外診断用医療機器</p> </li> </ul> </div> </section> <section id="" class="section-layout-standard content content-split content-wide bg-bsi-white" data-component="content-block"> <div class="container"> <div class="content-inner"> <div class="content-column"> <h2 class="title heading-l">BSIによるCEマーキングのメリット</h2> </div> <div class="content-column"> <div class="sub-heading-s">BSI The Netherlands（2797）は、MDRおよびIVDRに基づき、3種類すべての機器について指定されたフルスコープのノーティファイドボディです。</div> <div class="body-m content-body"><p>メーカーとしては、医療機器の認証が簡素化され、異なるノーティファイドボディ間で製品ポートフォリオを管理する手間が省けます。<br /><br />当社のチームは、お客様の技術文書を厳密に審査できる独自の専門知識を保有しています。製品認証に至るまで、専任のBSIスキームマネージャーが担当し、その後も窓口となります。</p></div> <div class="button-wrap"> <a href="/ja-JP/forms/request-a-quote-medical-devices/" class="button button-primary" title="見積もりをリクエスト" target=""> 見積もりをリクエスト </a> </div> </div> </div> </div> </section> <section id="" class="section-layout-standard section-layout-standard-2 bg-bsi-white" data-component="resources-block"> <div class="section-layout-standard-inner container"> <div class="col col-floater"> <span class="badge">洞察とメディア</span> <h2 class="title">世界的エキスパートからヘルスケアの専門知識を学ぶ</h2> <a href="/ja-JP/insights-and-media/" title="洞察とメディアを入手" class="button button-secondary button-floater"> 洞察とメディアを入手 </a> </div> <div class="col resource-container"> <div class="resource"> <a class="resource-link" href="/ja-JP/insights-and-media/media/webinars/ivdr-companion-diagnostics-cdx-update/" title="IVDRコンパニオン診断薬（CDx）の最新情報"> <picture class="resource-image"> <source media="(min-width: 960px)" srcset="/siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-021426756188-1123-img.jpg?imwidth=544, /siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-021426756188-1123-img.jpg?imwidth=544&imdensity=2 2x"> <source media="(min-width: 480px)" srcset="/siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-021426756188-1123-img.jpg?imwidth=959, /siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-021426756188-1123-img.jpg?imwidth=959&imdensity=2 2x"> <source srcset="/siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-021426756188-1123-img.jpg?imwidth=447, /siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-021426756188-1123-img.jpg?imwidth=447"> <img src="/siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-021426756188-1123-img.jpg" alt="IVDRコンパニオン診断薬（CDx）の最新情報 - 研究室に2人の生物学者がいる様子" height="306" width="544"> </picture> <div class="resource-content-col"> <span class="badge">ウェビナー</span> <p class="resource-link-title heading-xs"> IVDRコンパニオン診断薬（CDx）の最新情報 </p> <p class="link-arrow" href="/ja-JP/insights-and-media/media/webinars/ivdr-companion-diagnostics-cdx-update/">ウェビナーを見る</p> </div> </a> </div> <div class="resource"> <a class="resource-link" href="/ja-JP/insights-and-media/media/webinars/clinical-evaluation-for-medical-software-and-ai-devices/" title="医療ソフトウェアとAI機器の臨床評価"> <picture class="resource-image"> <source media="(min-width: 960px)" srcset="/siteassets/images/1-1-squ/gl-grp-brand-health-mt-mp-03fairfordmedical3146-1123-img.jpg?imwidth=544, /siteassets/images/1-1-squ/gl-grp-brand-health-mt-mp-03fairfordmedical3146-1123-img.jpg?imwidth=544&imdensity=2 2x"> <source media="(min-width: 480px)" srcset="/siteassets/images/1-1-squ/gl-grp-brand-health-mt-mp-03fairfordmedical3146-1123-img.jpg?imwidth=959, /siteassets/images/1-1-squ/gl-grp-brand-health-mt-mp-03fairfordmedical3146-1123-img.jpg?imwidth=959&imdensity=2 2x"> <source srcset="/siteassets/images/1-1-squ/gl-grp-brand-health-mt-mp-03fairfordmedical3146-1123-img.jpg?imwidth=447, /siteassets/images/1-1-squ/gl-grp-brand-health-mt-mp-03fairfordmedical3146-1123-img.jpg?imwidth=447"> <img src="/siteassets/images/1-1-squ/gl-grp-brand-health-mt-mp-03fairfordmedical3146-1123-img.jpg" alt="超音波スキャン用スキャニングベッド" height="306" width="544"> </picture> <div class="resource-content-col"> <span class="badge">ウェビナー</span> <p class="resource-link-title heading-xs"> 医療ソフトウェアとAI機器の臨床評価 </p> <p class="link-arrow" href="/ja-JP/insights-and-media/media/webinars/clinical-evaluation-for-medical-software-and-ai-devices/">ウェビナーを見る</p> </div> </a> </div> <div class="resource"> <a class="resource-link" href="/ja-JP/insights-and-media/insights/whitepapers/medical-device-lifetime/" title="医療機器のライフタイム"> <picture class="resource-image"> <source media="(min-width: 960px)" srcset="/siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-02827581034-0823-img.jpg?imwidth=544, /siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-02827581034-0823-img.jpg?imwidth=544&imdensity=2 2x"> <source media="(min-width: 480px)" srcset="/siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-02827581034-0823-img.jpg?imwidth=959, /siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-02827581034-0823-img.jpg?imwidth=959&imdensity=2 2x"> <source srcset="/siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-02827581034-0823-img.jpg?imwidth=447, /siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-02827581034-0823-img.jpg?imwidth=447"> <img src="/siteassets/images/1-1-squ/gl-gmkt-brand-hc-mt-mp-02827581034-0823-img.jpg" alt="スコープを使用する2人の看護師" height="306" width="544"> </picture> <div class="resource-content-col"> <span class="badge">白書</span> <p class="resource-link-title heading-xs"> 医療機器のライフタイム </p> <p class="link-arrow" href="/ja-JP/insights-and-media/insights/whitepapers/medical-device-lifetime/">ホワイトペーパーを読む</p> </div> </a> </div> </div> </div> </section> <section id="" class="section-layout-standard padding-exception contact-with-bg-image bg-bsi-white" data-component="contact-block"> <div class="container"> <div class="contact-content-offset bg-bsi-purple-20"> <span class="badge">お問い合わせ</span> <h2 class="title">連絡する</h2> <p class="contact-content-text body-m">認証プロセスを開始される場合、移転をお考えの場合、またはビジネス上の選択肢についてご相談される場合など、どのような場合にもサポートします。</p> <div class="button-wrap"> <a href="/ja-JP/forms/request-a-quote-medical-devices/" class="button button-primary" title="見積もりをリクエスト"> 見積もりをリクエスト </a> </div> </div> </div> <picture class="contact-bg-image"> <source media="(min-width: 960px)" srcset="/siteassets/1-placeholder/contact-us-bsi.png?imwidth=512, /siteassets/1-placeholder/contact-us-bsi.png?imwidth=512&imdensity=2 2x"> <img src="/siteassets/1-placeholder/contact-us-bsi.png" alt="連絡する" height="604" width="512"> 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<p>当社は、公平性を重んじ、コンプライアンスを遵守しています。当社は、EUノーティファイドボディ、英国認可機関、MDSAP認定審査機関として、医療機器メーカー、その公認代理人、サプライヤー、または商業上の競合他社に対して、審査対象の医療機器またはプロセスの設計、製造、構築、マーケティング、設置、使用、またはメンテナンス/修理に関するコンサルティングサービスを提供することはできません。このメッセージは、今後当サイトにアクセスする際の注意事項として表示されます。</p> <div class="button-row"> <a id="consultancyEntryUrl" class="btn" href='' data-cookie="consultancymdpersis">続行する</a> <a id="close" class="btn close">閉じる</a> </div> `; const exitBlockContent = `  <p>当社は、公平性を重んじ、コンプライアンスを遵守しています。当社は、EUノーティファイドボディ、英国認可機関、MDSAP認定審査機関として、医療機器メーカー、その公認代理人、サプライヤー、または商業上の競合他社に対して、審査対象の医療機器またはプロセスの設計、製造、構築、マーケティング、設置、使用、またはメンテナンス/修理に関するコンサルティングサービスを提供することはできません。このメッセージは、今後当サイトにアクセスする際の注意事項として表示されます。</p> <div class="button-row"> <a id="consultancyExitUrl" class="btn" href='' data-cookie="consultancyexitmdpersis">続行する</a> <a id="close" class="btn close">閉じる</a> </div> `; const modalEntry = (blockContent) => { return `<div class="impartiality-modal"> <style> .impartiality-modal { position: fixed; top: 0; left: 0; width: 100%; 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