HKQAA  
 
RSS
Quick Search
 

Training

Courses in Hong Kong

[MT22] 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

 

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

  

Remarks: “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.”

Course Code Date Duration Course Fee Course Fee (Early Bird) Language Location
MT22C/HK-10A 18 Oct 2021 1 day 1880 1580 Cantonese with English materials 19/F K Wah Centre 191 Java Road North Point Hong Kong
MT22C/HK-11A 19 Nov 2021 1 day 1880 1580 Cantonese with English materials 19/F K Wah Centre 191 Java Road North Point Hong Kong
MT22C/HK-12A 17 Dec 2021 1 day 1880 1580 Cantonese with English materials 19/F K Wah Centre 191 Java Road North Point Hong Kong

申請 條款及條件

 

 

Last Update: 2021-12-03   Disclaimer and Copyright
Copyright © 2009 Hong Kong Quality Assurance Agency. All rights reserved.