醫療器材系列課程
國內醫療器材多銷售至海外市場，又以歐盟、美國等醫療先進國家為我國醫材主要輸銷區域，製造商面臨具挑戰性的國際法規及法令的遵循要求，不但需要專屬的品質管理系統來做到更適切且全面的醫材品質管理，產品取得歐盟 CE 驗證更是進入歐洲市場的必備要求。BSI 提供完整的 ISO 13485 醫療器材品質管理、ISO 14971 醫療器材風險管理及 CE Marking 等系列課程，協助醫材廠商確保品質、符合法規要求，順利拓展市場。
BSI醫療器材線上隨選課程(英文)
醫療器材品質、風險管理與歐盟法規是外銷歐盟的醫療器材製造商必須掌握的知識。BSI推出的一系列線上隨選課程（皆為英文原廠內容）可以讓您用自己的步調學習相關概念和知識，也有助於進階到講師帶領的課程之前打好基礎，提高學習效果。
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ISO 13485 Quality Management Systems - Requirements for Regulatory Purposes Awareness On-demand Training Course >
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ISO 13485:2016 Requirements E-Learning Training Course >
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Awareness of the In Vitro Diagnostic Regulation On-demand Training Course >
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Requirements of the In Vitro Diagnostic Regulation On-demand Training Course >
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Implementation of the In Vitro Diagnostic Device Regulation (IVDR) for CE Marking On-demand eLearning course >
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Performance evaluation and clinical evidence for In Vitro Diagnostics (IVDs) >
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Requirements of the Medical Device Regulation (MDR) On-demand Training Course >
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The hidden stings of the Medical Device Regulation (MDR) – Annex VII On-demand training course >
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Requirements for Risk Classification in the Medical Device Regulation (EU MDR 2017/745) On-demand training course >
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The Obligations for Economic Operators within the Medical Device Regulations (EU MDR 2017/745) On-demand training course >
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ISO 14971:2019 Risk Management for Medical Devices: Requirements on-demand eLearning course >
