医療機器による患者の安全とケアの質| BSI

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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">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 href="/globalassets/localfiles/en-gb/about-bsi/training-terms-and-conditions-may-2020.pdf" target="_blank" title="研修利用規約" class="nav-link-side">研修利用規約</a></li> </ul> </li> <li> <a href="/ja-JP/about-bsi/our-history/" target="" title="沿革" class="nav-link-side">沿革</a> </li> <li> <a href="javascript:;" class="nav-link-side nav-second-lvl-side">人材</a> <ul class="nav-sub-lvl-side 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/siteassets/images/16-9-lnd/gl-gmkt-brand-hc-mt-mp-021148818334-1123-img.jpg?imwidth=1081&imdensity=2 2x" /> <source srcset="/siteassets/images/16-9-lnd/gl-gmkt-brand-hc-mt-mp-021148818334-1123-img.jpg?imwidth=375, /siteassets/images/16-9-lnd/gl-gmkt-brand-hc-mt-mp-021148818334-1123-img.jpg?imwidth=375" /> <img src="/siteassets/images/16-9-lnd/gl-gmkt-brand-hc-mt-mp-021148818334-1123-img.jpg" alt="トロッカー付き腹腔鏡把持器を持つ男女の手のクローズアップ" width="704" height="396"> </picture> </div> <div class="content-column"> <span class="badge">ケイパビリティ</span> <h1 class="title">医療機器</h1> <p class="sub-heading-s content-column-text"> 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> </div> </div> </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"> <span class="badge">当社の使命</span> <h2 class="title heading-l">当社の使命は、持続可能な方法で医療技術へのタイムリーなマーケットアクセスを支援しながら、患者の安全を確保することです。</h2> </div> <div class="content-column"> <div class="sub-heading-s">当社は、公平で、迅速で、堅牢かつ徹底した適合性評価、評価、認証を実施することにより、世界標準を確立し、世界中で認められ、信頼されるよう努めています。</div> <div class="body-m content-body"><p>BSIには、193カ国以上で1万2,000人の業界専門家にサポートされている5,000人の職員がいます。当社のレギュラトリーサービスは、世界をリードする経験と相まって、お客様のデバイスを市場に投入するための効率的なパスウェイを提供します。</p></div> <div class="button-wrap"> <a href="/ja-JP/forms/general-enquiry/" class="button button-primary" title="連絡する" target=""> 連絡する </a> </div> </div> </div> </div> </section> <section id="" class="section-layout-standard section-layout-standard-2 bg-bsi-soft-white" data-component="list-all-variants-block"> <div class="section-layout-standard-inner container"> <div class="col col-floater"> <h2 class="title">品質を維持し、卓越したものを提供する</h2> <p class="sub-heading-s">BSI Medical Devicesは、安全でコンプライアンスに準拠した医療機器を市場に投入するための認証サービスを提供しています。当社の紹介：</p> </div> <ul class="list list-icons"> <li class="list-item"> <figure class="list-item-icon"> <img src="/siteassets/images/icons/tick.png?imwidth=32" alt="チェックマーク" height="32" width="32"> </figure> <p>主要なフルスコープノーティファイドボディ（2797）。</p> <a href=/ja-JP/products-and-services/medical-devices/ce-marking/ target="" class="link-arrow" title="詳細はこちら"> 詳細はこちら </a> </li> <li class="list-item"> <figure class="list-item-icon"> <img src="/siteassets/images/icons/tick.png?imwidth=32" alt="チェックマーク" height="32" width="32"> </figure> <p>英国の主要な総合認証機関（0086）。</p> <a href=/ja-JP/products-and-services/medical-devices/ukca-marking/ target="" class="link-arrow" title="詳細はこちら"> 詳細はこちら </a> </li> <li class="list-item"> <figure class="list-item-icon"> <img src="/siteassets/images/icons/tick.png?imwidth=32" alt="チェックマーク" height="32" width="32"> </figure> <p>認定されているISO 13485認証機関。</p> <a href=/ja-JP/products-and-services/standards/iso-13485-quality-management-system/ target="" class="link-arrow" title="詳細はこちら"> 詳細はこちら </a> </li> <li class="list-item"> <figure class="list-item-icon"> <img src="/siteassets/images/icons/tick.png?imwidth=32" alt="チェックマーク" height="32" width="32"> </figure> <p>医療機器単一調査プログラム（MDSAP）に基づき認定されている監査機関。</p> <a href=/ja-JP/products-and-services/medical-devices/mdsap/ target="" class="link-arrow" title="詳細はこちら"> 詳細はこちら </a> </li> <li class="list-item"> <figure class="list-item-icon"> <img src="/siteassets/images/icons/tick.png?imwidth=32" alt="チェックマーク" height="32" width="32"> </figure> <p>多くのグローバル市場における適合性評価機関および登録認証機関。</p> <a href=/ja-JP/products-and-services/medical-devices/global-market-access-for-medical-device-manufacturers/ target="" class="link-arrow" title="詳細はこちら"> 詳細はこちら </a> </li> <li class="list-item"> <figure class="list-item-icon"> <img src="/siteassets/images/icons/tick.png?imwidth=32" alt="チェックマーク" height="32" width="32"> </figure> <p>ノーティファイドボディの能力とリードタイムMDRおよびIVDR申請および適合性評価。</p> <a href=/siteassets/pdf/en/insights-and-media/insights/brochures/bsi-md-nb-capacity-lead-times-en-gb.pdf target="" class="link-arrow" title="詳細はこちら"> 詳細はこちら </a> </li> </ul> </div> </section> <section id="" class="section-layout-standard content content-split content-wide content-image bg-bsi-white" data-component="content-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/1-1-squ/gl-gmkt-brand-hc-hsw-dor-02930026606-1123-img.jpg?imwidth=544, /siteassets/images/1-1-squ/gl-gmkt-brand-hc-hsw-dor-02930026606-1123-img.jpg?imwidth=544&imdensity=2 x2"> <source srcset="/siteassets/images/1-1-squ/gl-gmkt-brand-hc-hsw-dor-02930026606-1123-img.jpg?imwidth=343, /siteassets/images/1-1-squ/gl-gmkt-brand-hc-hsw-dor-02930026606-1123-img.jpg?imwidth=343"> <img src="/siteassets/images/1-1-squ/gl-gmkt-brand-hc-hsw-dor-02930026606-1123-img.jpg" alt="顕微鏡を使う科学者" height="544" width="544"> </picture> </div> <div class="content-column"> <span class="badge">サービス＆料金</span> <h2 class="title heading-l">MDRおよびIVDRのサービスと料金</h2> <div class="body-m content-body"><p>2024年1月1日以降発効のIVDRおよびMDR適合性評価に関する料金をダウンロードできます。</p></div> <div class="button-wrap"> <a href="/siteassets/pdf/en/insights-and-media/insights/brochures/bsi-md-conformity-assessment-services-and-fees-mdr-eur-en-gb.pdf" class="button button-primary" title="MDRサービス＆料金" target="_blank"> MDRサービス＆料金 </a> <a href="/siteassets/pdf/en/insights-and-media/insights/brochures/bsi-md-conformity-assessment-services-and-fees-ivdr-eur-en-gb.pdf" class="button button-secondary" title="IVDRサービス＆料金" target="_blank"> IVDRサービス＆料金 </a> </div> </div> </div> </div> </section> <section id="" class="section-layout-standard content content-split content-wide content-image content-image-right bg-bsi-white" data-component="content-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/1-1-squ/gl-gmkt-brand-hc-hsw-mp-021349025816-1023-img.jpg?imwidth=544, /siteassets/images/1-1-squ/gl-gmkt-brand-hc-hsw-mp-021349025816-1023-img.jpg?imwidth=544&imdensity=2 x2"> <source srcset="/siteassets/images/1-1-squ/gl-gmkt-brand-hc-hsw-mp-021349025816-1023-img.jpg?imwidth=343, /siteassets/images/1-1-squ/gl-gmkt-brand-hc-hsw-mp-021349025816-1023-img.jpg?imwidth=343"> <img src="/siteassets/images/1-1-squ/gl-gmkt-brand-hc-hsw-mp-021349025816-1023-img.jpg" alt="話し合う医師と患者" height="544" width="544"> </picture> </div> <div class="content-column"> <span class="badge">ポリシー</span> <h2 class="title heading-l">BSIレギュラトリーサービス認証ビジネスポリシー</h2> <div class="body-m content-body"><p>BSI Assurance UK Ltd.、BSI Group The Netherlands B.V.およびBSI Group America Inc.は、マネジメントシステムのアセスメントおよび認証を提供する第三者認定/公認認証機関（UKAS、RvAおよび医療機器単一調査プログラム（MDSAP））です。</p></div> <div class="button-wrap"> <a href="/siteassets/pdf/en/insights-and-media/insights/brochures/bsi-md-med-dev-certification-policy-en-gb.pdf" class="button button-primary" title="認証ポリシー" target="_blank"> 認証ポリシー </a> </div> </div> </div> </div> </section> <section id="" class="section-feature section-layout-standard section-layout-standard-2 bg-bsi-purple-20" data-component="feature-block"> <div class="section-layout-standard-inner container"> <div class="col col-floater"> <span class="badge">当社の専門家</span> <h2 class="title heading-l">当社のテクニカルチーム</h2> <p class="sub-heading-s mb0"></p> </div> <div class="col feature-container swiper" id="feature-section-a8502ff4-de9c-49d6-9a23-d87def0cfa53" data-id="feature-section-a8502ff4-de9c-49d6-9a23-d87def0cfa53" data-slides="3"> <span class="feature-list swiper-wrapper"> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/aimd/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">テクニカルチーム</span> <h3 class="title heading-xs">能動埋め込み型医療機器（AIMD）</h3> <p class="body-m my0">ペースメーカー、除細動器、神経刺激システム、人工内耳、輸液ポンプ、植え込み型グルコースモニター、MEMなど、その他多数が含まれます。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/our-expertise/digital-trust/artificial-intelligence/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">テクニカルチーム</span> <h3 class="title heading-xs">人工知能（AI）</h3> <p class="body-m my0">医療機器へのAIの適用ケースを発見し、この成長市場に参入するための関連規制要件を満たしていることを確認してください。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/general-medical-devices/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">テクニカルチーム</span> <h3 class="title heading-xs">一般医療機器</h3> <p class="body-m my0">植込み型、創傷・スキンケア、眼科用、輸液・輸血用医療機器など、その他多数が含まれます。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/ivd/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">テクニカルチーム</span> <h3 class="title heading-xs">体外診断用医療機器</h3> <p class="body-m my0">血糖値モニター、自己検査、コンパニオン診断、ヒト遺伝子検査、免疫アッセイ、がん診断、血液型分類など、その他多数が含まれます。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/orthodental/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">テクニカルチーム</span> <h3 class="title heading-xs">整形外科用および歯科用医療機器</h3> <p class="body-m my0">軟組織アンカー、股関節や膝関節のインプラント、歯科用インプラントやセメントなどの整形外科用インプラントなど、その他多数が含まれます。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/active-medical-devices/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">テクニカルチーム</span> <h3 class="title heading-xs">能動医療機器</h3> <p class="body-m my0">X線装置、手術室機器、手術用ロボット、ソフトウェア機器、輸液ポンプ、手術用ドリル、人工呼吸器など、その他多数が含まれます。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/medicinal-and-biologics/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">テクニカルチーム</span> <h3 class="title heading-xs">医薬品・生物製剤</h3> <p class="body-m my0">体外受精、動物組織器具、臓器保存、MDR規則21、規則14、第117条器具など、その他多数が含まれます。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/microbiology/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">テクニカルチーム</span> <h3 class="title heading-xs">微生物学および滅菌医療機器</h3> <p class="body-m my0">蒸気、酸化エチレン、放射線などの滅菌サービスだけでなく、無菌充填、管理された環境など、その他多数のさまざまなサービスが含まれます。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/vascular-medical-devices/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">当社のテクニカルチーム</span> <h3 class="title heading-xs">循環器用医療機器</h3> <p class="body-m my0">心臓バルブ、心不全治療器、構造的心臓閉塞器、血管グラフト、ステントグラフト、カテーテル、ガイドワイヤーなど、その他多数が含まれます。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> </span> </div> <div class="swiper-controls"> <div class="swiper-pagination swiper-pagination-feature-section-a8502ff4-de9c-49d6-9a23-d87def0cfa53"></div> <div class="swiper-arrows-container"> <button class="swiper-button swiper-prev swiper-prev-feature-section-a8502ff4-de9c-49d6-9a23-d87def0cfa53">Prev</button> <button class="swiper-button swiper-next swiper-next-feature-section-a8502ff4-de9c-49d6-9a23-d87def0cfa53">Next</button> </div> </div> </div> </section> <section id="" class="tabs-section section-layout-standard section-layout-standard-2 bg-bsi-white" data-component="tab-section-block"> <div class="section-layout-standard-inner container"> <div class="col col-floater"> <span class="badge">当社のプロセス</span> <h2 class="title">医療機器の製品開発ライフサイクルのどの段階にありますか？</h2> <p class="sub-heading-s">製品が製品ライフサイクルのどの段階にあるかを示すステージを選択すると、さらに検討すべき事項を特定するのに役立ちます。</p> </div> </div> <div class="container"> <div class="tabs tabs-content-split"> <ul class="tabs-selectors"> <li class="tabs-selector tabs-selector-active" data-tab="tab-section-62c9610b-e0dc-49b3-8293-792a70496068-1" tabindex="0">第1段階：コンセプト</li> <li class="tabs-selector" data-tab="tab-section-62c9610b-e0dc-49b3-8293-792a70496068-2" tabindex="0">第2段階：計画</li> <li class="tabs-selector" data-tab="tab-section-62c9610b-e0dc-49b3-8293-792a70496068-3" tabindex="0">第3段階：デザイン</li> <li class="tabs-selector" data-tab="tab-section-62c9610b-e0dc-49b3-8293-792a70496068-4" tabindex="0">第4段階：妥当性確認</li> <li class="tabs-selector" data-tab="tab-section-62c9610b-e0dc-49b3-8293-792a70496068-5" tabindex="0">第5段階：発表</li> <li class="tabs-selector" data-tab="tab-section-62c9610b-e0dc-49b3-8293-792a70496068-6" tabindex="0">第6段階：ポストマーケット</li> </ul> <div class="tabs-content-wrapper"> <div class="tabs-content tabs-content-active" data-content="tab-section-62c9610b-e0dc-49b3-8293-792a70496068-1"> <div class="content-column"> <span class="badge">第1段階：コンセプト</span> <h2 class="title heading-m">商業製品の開発可能性の初期評価</h2> <div class="body-m content-body"><ul> <li>医療機器であるかの判断</li> <li>使用目的</li> <li>初期リスク分析</li> <li>製品定義と知的財産</li> <li>ビジネスプラン</li> <li>潜在市場とルート</li> <li>規制戦略草案</li> <li>人員/リソース要求事項</li> </ul></div> </div> </div> <div class="tabs-content" data-content="tab-section-62c9610b-e0dc-49b3-8293-792a70496068-2"> <div class="content-column"> <span class="badge">第2段階：計画</span> <h2 class="title heading-m">顧客ニーズと技術的要求事項に基づく設計インプットの定義</h2> <div class="body-m content-body"><ul> <li>コンセプト開発</li> <li>プロトタイプ分析</li> <li>初期テスト</li> <li>デザインファイルとリスク分析</li> <li>ユーザーのフィードバック</li> <li>ビジネスおよび市場戦略</li> <li>規制戦略</li> <li>品質マネジメントシステム</li> <li>プロジェクト計画</li> </ul></div> </div> </div> <div class="tabs-content" data-content="tab-section-62c9610b-e0dc-49b3-8293-792a70496068-3"> <div class="content-column"> <span class="badge">第3段階：デザイン</span> <h2 class="title heading-m">製品設計と製造プロセス、検証と妥当性確認</h2> <div class="body-m content-body"><ul> <li>ユーザーのフィードバック </li> <li>製造プロセス</li> <li>設計検証と妥当性確認</li> <li>リスクマネジメント</li> <li>技術文書の草稿</li> <li>規制戦略</li> <li>製品クレームとブランディング</li> <li>規制要求事項</li> </ul></div> </div> </div> <div class="tabs-content" data-content="tab-section-62c9610b-e0dc-49b3-8293-792a70496068-4"> <div class="content-column"> <span class="badge">第4段階：妥当性確認</span> <h2 class="title heading-m">製造プロセスの妥当性確認、製品導入の準備</h2> <div class="body-m content-body"><ul> <li>市場計画/予測</li> <li>プロセス検証</li> <li>臨床的検証</li> <li>製品クレーム</li> <li>最終ラベリング</li> <li>規制当局への申請</li> <li>製品償還</li> <li>EU CEマーキングおよび英国適合性評価（UKCA）マーク</li> <li>グローバルマーケットアクセス認証</li> </ul></div> </div> </div> <div class="tabs-content" data-content="tab-section-62c9610b-e0dc-49b3-8293-792a70496068-5"> <div class="content-column"> <span class="badge">第5段階：発表</span> <h2 class="title heading-m">製品発表</h2> <div class="body-m content-body"><ul> <li>規制承認</li> <li>営業および臨床医トレーニング</li> <li>製品の市場投入</li> <li>各国の償還承認</li> </ul></div> </div> </div> <div class="tabs-content" data-content="tab-section-62c9610b-e0dc-49b3-8293-792a70496068-6"> <div class="content-column"> <span class="badge">第6段階：ポストマーケット</span> <h2 class="title heading-m">ポストマーケットサーベイランス</h2> <div class="body-m content-body"><ul> <li>ポストマーケットサーベイランス</li> <li>市販後の臨床フォローアップ</li> <li>苦情および有害事象</li> <li>製品改良</li> <li>プロセス改善</li> <li>外部機関による監査</li> <li>市場パフォーマンス</li> <li>新市場の立ち上げ</li> </ul></div> </div> </div> </div> </div> </div> </section> <section id="" class="section-layout-standard banner bg-bsi-soft-white" data-component="banner-block"> <div class="container banner-content-wrapper"> <picture class="banner-image"> <source media="(min-width: 960px)" srcset="/siteassets/images/1-1-squ/gl-kscn-cross-brand-ms-mt-nsp-mp-01ipadcompliancenavigatorlsqu-1223-img.png?imwidth=448, /siteassets/images/1-1-squ/gl-kscn-cross-brand-ms-mt-nsp-mp-01ipadcompliancenavigatorlsqu-1223-img.png?imwidth=448?imdensity=2 2x"> <source srcset="/siteassets/images/1-1-squ/gl-kscn-cross-brand-ms-mt-nsp-mp-01ipadcompliancenavigatorlsqu-1223-img.png?imwidth=343, /siteassets/images/1-1-squ/gl-kscn-cross-brand-ms-mt-nsp-mp-01ipadcompliancenavigatorlsqu-1223-img.png?imwidth=343"> <img src="/siteassets/images/1-1-squ/gl-kscn-cross-brand-ms-mt-nsp-mp-01ipadcompliancenavigatorlsqu-1223-img.png" alt="コンプライアンス・ナビゲーターのホーム画面が表示されたタブレットを持つ女性" height="448" width="448"> </picture> <div class="banner-content bg-bsi-blue-20"> <div class="banner-content-left"> <span class="badge">テクノロジー</span> <h3 class="title">コンプライアンス・ナビゲーター</h3> <p class="banner-content-text sub-heading-s">医療機器、IVD、品質マネジメントシステム（QMS）などを規制する6,000以上の必須文書に対するコンプライアンスをモニタリングするために設計されたユニークなプラットフォームです。</p> </div> <div class="button-wrap"> <a href="/ja-JP/products-and-services/compliance-navigator/" class="button button-primary" title="詳細はこちら"> 詳細はこちら </a> </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">包括的で実績のある各種レギュラトリーサービス</h2> <p class="sub-heading-s mb0">当社は、お客様のデバイスを市場に送り出すための効率的なパスウェイを提供します。</p> <a href=/ja-JP/forms/request-a-quote-medical-devices/ target="" title="連絡する" class="button button-secondary button-floater"> 連絡する </a> </div> <div class="col feature-container swiper" id="feature-section-fa1b9aeb-f694-4a5b-b22b-2f9289cda598" data-id="feature-section-fa1b9aeb-f694-4a5b-b22b-2f9289cda598" data-slides="3"> <span class="feature-list swiper-wrapper"> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/medical-device-regulation-mdr/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">規制サービス</span> <h3 class="title heading-xs">欧州医療機器規則（MDR）</h3> <p class="body-m my0">欧州医療機器規則（MDR）は、EU医療機器指令（MDD）と能動埋め込み型医療機器（AIMDD）に取って代わるものです。2017年5月25日に発効され、2021年5月26日に適用されました。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/ivdr/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">規制サービス</span> <h3 class="title heading-xs">欧州医療機器規則（IVDR）</h3> <p class="body-m my0">IVDRは、体外診断用医療機器指令（IVDD）に代わり、2017年5月26日に発効され、2022年5月26日に適用されました。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/ce-marking/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">規制サービス</span> <h3 class="title heading-xs">CEマーキング</h3> <p class="body-m my0">CEマーキングとは、製品がEU MDRの安全性および性能に関する一般要求事項（GSPR）を満たしていることを医療機器メーカーが主張するものです。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/ukca-marking/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">規制サービス</span> <h3 class="title heading-xs">英国基準適合評価（UKCA）マーク</h3> <p class="body-m my0">英国適合性評価（UKCA）マークとは、医療機器メーカーが、その製品が英国MDR（2002年）の必須要求事項（ER）を満たしていることを主張するものです。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/standards/iso-13485-quality-management-system/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">規制サービス</span> <h3 class="title heading-xs">ISO 13485 - 品質マネジメントシステム</h3> <p class="body-m my0">ISO13485は、医療機器産業における品質マネジメントシステム（QMS）のための整合化された国際的に認知された規格です。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/mdsap/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">規制サービス</span> <h3 class="title heading-xs">医療機器単一調査プログラム（MDSAP）</h3> <p class="body-m my0">医療機器単一調査プログラム（MDSAP）は、医療機器メーカーの品質マネジメントシステム（QMS）を1回で監査し、複数の規制管轄区域の要求事項を満たすことを可能にします。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="https://knowledge.bsigroup.com/products/medical-devices-application-of-risk-management-to-medical-devices-1?version=standard" title="詳細はこちら" target="_blank"> <div class="feature-content"> <span class="badge">規制サービス</span> <h3 class="title heading-xs">ISO 14971医療機器のリスクマネジメント</h3> <p class="body-m my0">ISO 14971:2019は、医療機器のリスクマネジメントシステムの国際的な要求事項を定義しています。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/standards/en-60601-medical-electrical-equipment-and-systems/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">規制サービス</span> <h3 class="title heading-xs">EN 60601医用電気機器およびシステム</h3> <p class="body-m my0">EN 60601は、医用電気機器および関連システムの安全性と基本パフォーマンスをカバーする規格群です。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/global-market-access-for-medical-device-manufacturers/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">規制サービス</span> <h3 class="title heading-xs">医療機器メーカーのグローバルマーケットアクセス</h3> <p class="body-m my0">当社は、世界中のメーカーに医療機器認証サービスを提供しています。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> <span class="feature-item swiper-slide"> <a class="feature feature-link" href="/ja-JP/products-and-services/medical-devices/small-and-medium-enterprises-smes/" title="詳細はこちら"> <div class="feature-content"> <span class="badge">規制サービス</span> <h3 class="title heading-xs">中小企業（SME）</h3> <p class="body-m my0">当社は、市場参入に向けて主要な規制トピックに関する知識を深めることで、中小企業（SME）をサポートするために、幅広いリソースを提供しています。</p> <p class="link-arrow">詳細はこちら</p> </div> </a> </span> </span> </div> <div class="swiper-controls"> <div class="swiper-pagination swiper-pagination-feature-section-fa1b9aeb-f694-4a5b-b22b-2f9289cda598"></div> <div class="swiper-arrows-container"> <button class="swiper-button swiper-prev swiper-prev-feature-section-fa1b9aeb-f694-4a5b-b22b-2f9289cda598">Prev</button> <button class="swiper-button swiper-next swiper-next-feature-section-fa1b9aeb-f694-4a5b-b22b-2f9289cda598">Next</button> </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"> <span class="badge">当社の役割</span> <h2 class="title heading-l">ノーティファイドボディおよび英国の承認機関の役割</h2> <div class="sub-heading-s">ノーティファイドボディおよび英国承認機関の役割は、それぞれ関連するEU規則（MDRおよびIVDR）または英国法（UK MDR 2002）に基づく適合性評価を実施することです。</div> <div class="body-m content-body"><p>適合性評価には通常、メーカーの品質マネジメントシステム（QMS）の監査があります。機器の分類によっては、機器の安全性・パフォーマンスの要求事項（EU）または必須要求事項（英国）をサポートするためにメーカーから提供された関連技術文書のレビューが含まれます。</p></div> </div> <div class="content-column"> <span class="badge">会社概要</span> <h3 class="title heading-l">王室認可の英国初の国家標準化機関</h3> <div class="sub-heading-s">BSI Medical Devicesは、いくつかのグローバル市場でISO 13485の認証機関として認定されており、医療機器単一調査プログラム（MDSAP）の監査機関として認められています。</div> <div class="body-m content-body"><p>BSI The Netherlands（2797）は、主要なフルスコープノーティファイドボディです。BSI UK（0086）は、英国の主要なフルスコープ認証機関です。医療機器とIVDを審査し、欧州と英国の法規制要件に対する適合性を確認します。</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">リソース</span> <h2 class="title heading-l">ノーティファイドボディおよび英国承認機関の管轄外のこと</h2> <p class="sub-heading-s mb0">当社は、最高の専門家としてのインテグリティさと公平性をもって、適合性評価と検証活動を実施します。</p> </div> <div class="col feature-container"> <span class="feature-list"> <span class="feature-item"> <div class="feature"> <div class="feature-content"> <h3 class="title heading-xs">当社は、EUおよび英国の法律に関して、執筆権も決定権もありません</h3> <p class="body-m my0">当社の意見は討論の段階で考慮されます。当社は、関連する法律の要求事項に照らし合せて評価します。</p> </div> </div> </span> <span class="feature-item"> <div class="feature"> <div class="feature-content"> <h3 class="title heading-xs">当社は、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</h3> <p class="body-m my0">医療機器およびIVDの設計、開発、販売もしくは保守、またはアセスメント中のプロセスに関すること。</p> </div> </div> </span> </span> </div> </div> </section> <section id="" class="section-layout-standard section-layout-standard-1 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">さまざまな無料ウェビナーやライブウェビナー</h2> <p class="sub-heading-s mb0">BSIの技術専門家が主催し、法律、リスク、規制の変更など、お客様のビジネスに影響を与える重要なトピックを取り上げます。</p> <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/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-feature section-layout-standard section-layout-standard-2 bg-bsi-purple-20" data-component="feature-block"> <div class="section-layout-standard-inner container"> <div class="col col-floater"> <span class="badge">リソース</span> <h2 class="title heading-l">包括的で実績のある各種リソース</h2> <p class="sub-heading-s mb0">当社は、お客様のデバイスを市場に送り出すための効率的なパスウェイを提供します。</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="パンフレットを読む" 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">パンフレットを読む</p> </div> </a> </span> <span class="feature-item"> <a class="feature feature-link" href="/siteassets/pdf/en/insights-and-media/insights/brochures/bsi-md-eudamed-brochure-en-gb.pdf" title="パンフレットを読む" target="_blank"> <div class="feature-content"> <span 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