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ISO 13485:2016 為最新的醫療器材產業品質管理系統要求標準, 該標準強化了醫療器材法規對品質管理系統的要求, 整合了美國FDA與歐盟醫療器材法規的主流規定。預期發展成為GMP/ MDSAP與MDD指令的強制性標準。執行內部稽核來確保醫療器材業者的品質管理系統能持續符合法規與品質系統要求, 在ISO 13485系統中是至為關鍵的流程。而ISO 13485內部稽核員的能力與訓練，為法規單位最重視的人員資格。參加SGS ISO 13485:2016內部稽核人員訓練。是醫療器材界滿足法規要求,提升員工能力,增加專業經歷的最佳方案。原價NT$12,000，網路優惠價NT$11,400

MDSAP專案是國際醫療器械監管者論壇（IMDRF）為簡化醫材主管機關的監管負擔、促進產業發展，針對醫療器械製造商品質管制體系，而發起的一個計畫。此專案已獲得美國食藥品監督管理局（FDA）、加拿大衛生局（Health Canada）、澳大利亞治療品管理局（TGA）、巴西國家衛生監督局（ANVISA）、日本厚生勞動省（MHLW）之日本藥品及醫療器械管理局（PMDA）的認可，於2017年正式運行。SGS已取得該審核機構資格。MDSAP使稽核過程更趨標準化，不僅減少了各國監管部門的例行檢查工作，也使得生產企業減少稽核次數及正常生產所帶來的干擾。此外，稽核依照參與國的既有法規要求，不額外增加要求，在醫療設備產業專屬標準ISO 13485的基礎上，涵蓋美國 、巴西、以及日本、加拿大、澳大利亞等國的醫療器械品質系統要求。本課程將以最簡單方式，介紹MDSAP的緣起、概念、流程、與ISO13485的差異以及稽核方向及要點，協助產業瞭解並著手建立以MDSAP為要求的品質管理系統，以符合MDSAP之審核。原價NT$8,000，網路優惠價NT$7,600

本課程目的在於提供醫療器材製造商上市後監督流程的指引，同時調和ISO 13485與ISO14971等相關國際標準，透過主動與系統性地收集與分析適當的資料與數據，從中獲取上市後活動的經驗並且作為回饋流程之輸入，滿足相關法規之需求。課程原價：NTD8,000(含稅)；網路優惠價：NTD7,600(含稅)

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)

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

This training introduces you to management responsibilities under ISO Management System Standards.COURSE CONTENTOverview of ISO Standards, Annex SL standardization, and the PDCA process for continual improvement.Key management responsibilities in Clause 5 (Leadership) and Clause 9 (Performance Evaluation).COURSE CERTIFICATION:On completion of this course:The SGS certificate is available to download once you have achieved a pass mark of 80% or more in the final assessment which completes this course.You have 12 months access to this course, effective from the date of purchase.

This eLearning course aims to familiarise you with the auditing management systems guidelines in accordance with ISO 19011:2018.