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香港課程

[MT22] ISO13485:2016 醫療器材品質管理系統標準 - 理解與應用

 

ISO13485:2016 Medical Devices QMS Requirements for Regulatory Purposes Understanding & Application

Course Objectives

  • Understand the principles, definitions, requirements of ISO13485:2016
  • Appreciate the actions required to establish a quality management system for manufacturing of medical devices
  • Aware of tools and techniques which can be applied to manage risks
  • Understand the preparation for certification

Course Topics

  • What are the key elements of ISO13485:2016?
  • What do we need to believe?
  • What do we need to know?
  • What are the roles of staff at all levels?
  • What do we want to achieve with a quality management system for medical devices?

Certificate of attendance

Certificate of Attendance will be issued to participants who have attended more than 90% of the enrolled course hours

 

  

備注: “HKQAA reserves the right to cancel the course, change the trainer, content, date, time and / or venue as necessary. Please read the terms and conditions at the bottom of this page before enrolment.”

課程編號 日期 時間 課程費用 課程費用 (提早報名) 語言 地點
MT22C/HK-09A 01 Sep 2020 1 day 1580 粵語 - 輔以英文講義 香港北角渣華道191號嘉華國際中心19樓
MT22C/HK-10A 12 Oct 2020 1 day 1580 粵語 - 輔以英文講義 香港北角渣華道191號嘉華國際中心19樓

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最後更新:2020-08-10    免責聲明
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