ISO 14971:2019醫療器材風險管理條文解說與實務應用

因為不足的醫療器材可用性而導致使用上錯誤已經逐漸成為關注的重點。許多醫療器材在開發過程中沒有導入可用性評估，將造成使用上不符合人的直覺習慣，難以學習且難以使用。EN 62366 / IEC 62366 已經是歐美各國做為醫材可用性分析與評估的參考依據，本課程提供醫材業者，在產品設計之初，藉了解預期使用者，進行風險分析，導入設計考量，並加以驗證，充分掌握產品，開發出安全、有效、容易操作並容易學習的醫療器材，以便產品加快上市時間，增加銷售量及滿意度，以及減少培訓和用戶服務需求或投訴。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

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)