Software validation軟體確效理論與實務訓練課程

隨著數位醫療、遠距醫療、AI醫療軟體（SaMD）、雲端醫療平台及智慧醫療器材快速發展，病患個人資料與健康資料的蒐集、傳輸、儲存及使用已成為全球監管機關高度關注的議題。歐盟《一般資料保護規則》（GDPR）與美國《健康保險可攜與責任法案》（HIPAA）為目前全球最具影響力之個人資料與健康資訊保護法規。醫療器材製造商、醫療軟體開發商、醫療服務提供者及相關供應商，如涉及歐盟或美國市場，皆需了解並建立符合法規要求之資料保護管理機制。本課程將深入解析GDPR與HIPAA的法規架構、核心要求、資料主體權利、資訊安全管理措施及資料外洩通報要求，並結合醫療器材產業實務案例，協助學員建立法規遵循能力與風險管理觀念。課程原價：NTD16,000(含稅)；網路優惠價：NTD15,200(含稅)

醫療器材的設計開發，在品質管理系統或是產品的認證上都扮演著重要的角色。本課程將由產業實務經驗及法規要求觀點出發，並且以ISO 13485: 2016設計開發流程為基礎，介紹醫療器材從設計規劃、研究設計、產品開發、驗證及臨床要求、到上市法規之完整研發流程，並且輔以真實稽核案例的分享與討論，建立學員對於整個醫療器材設計開發流程的清晰邏輯概念以及需要符合的基本法規要求。原價NT$6,000，網路優惠價NT$5,700

This course is certificated by the Chartered Quality Institute and International Register of Certificated Auditors (CQI/IRCA; Course Certification Number, 2428 - PR 369)Course Criteria - ObjectivesUpon completion of this course, learners will be able to:Explain the purpose of a medical device quality management system (MD QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standard, third-party certification, and the business benefits of the quality management system;Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up a quality management system  in accordance with ISO 19011 (and ISO 17021 where appropriate);Plan, conduct, report and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011, ISO/IEC 17021.Learners will need to demonstrate acceptable performance in these areas to complete the course successfully.Prior knowledge Before starting this course, learners are expected to have the following prior knowledge:ISO 13485Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD QMS ISO 13485:2016 Foundation (FD 132) course or equivalent.Medical Device management System AuditThe Plan, Do, Check, Act (PDCA) cycle.The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.The process approach used in MD QMS.A working knowledge of medical device regulatory process applicable to countries the course is designed to cover, including device regulations, regulatory auditing standards and their relationship with ISO 13485.  This knowledge may be gained by successfully completing a CQI and IRCA course relating to individual regulatory authority standards, which will be available subject to demand (e.g. MD QMS Comprehensive EU Medical Device Regulation 2017/745 (EU MRD) Practitioner - PT 219)A working knowledge of risk management principles related to the design of a medical device, for example ISO 14971