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[MT22] ISO13485:2016 Medical Devices QMS - Requirements for Regulatory Purposes - Understanding & Application

 


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
  • To provide a more comprehensive certificate service, please fill in the participant's name according to the identification document (as standard) when submitting the application form.

 

Click here to explore E-learning schedule

 

Should you have any questions, please free feel to contact Ms. Joanne Chan during office hour.

Tel: (852) 2202 9330 / (852) 6050 8153         Email: training@hkqaa.org

Office Hour: 9 a.m. to 6 p.m. (Monday to Friday)

 

  

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-07A 12 July 2022 1 day 1880 1580 Cantonese with English materials 19/F K Wah Centre 191 Java Road North Point Hong Kong
MT22C/HK-09A 21 September 2022 1 day 1880 1580 Cantonese with English materials 19/F K Wah Centre 191 Java Road North Point Hong Kong
MT22C/HK-11A 15 November 2022 1 day 1880 1580 Cantonese with English materials 19/F K Wah Centre 191 Java Road North Point Hong Kong

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Last Update: 2022-09-23   Disclaimer and Copyright
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