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香港课程

[MT22] ISO13485:2016 医疗器材质量管理系统标准 - 理解与应用

 

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

 

Should you have any questions, please contact Ms. Joanne Chan at 6050 8153 during office hour (9 a.m. to 6 p.m.) on Monday to Friday. 

 

Click here to explore E-learning schedule

  

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.”

课程编号

日期

时间

课程费用

课程费用 (提早报名)

语言

地点
MT22C/HK-01A 10 Jan 2022 1 day 1880 1580 粤语 - 辅以英文讲义 香港北角渣华道191号嘉华国际中心19楼
MT22C/HK-03A 16 Mar 2022 1 day 1880 1580 粤语 - 辅以英文讲义 香港北角渣华道191号嘉华国际中心19楼

申请 条款及条件

 

 

最后更新:2022-01-14    免责声明
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