Course Information
Schedules
- 17 Jan 2025 (Fri)
Registration period
23 Sep 2024 (Mon) - 16 Jan 2025 (Thu)
Price
HKD 1,480
Course Level
Study Mode
Duration
1 Day(s)
Language
Cantonese
Location
HKQAA Online Platform
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Course Overview
ISO13485:2016 Medical Devices QMS - Requirements for Regulatory Purposes -
Understanding & Application
Course Topics
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What are the key elements of ISO13485:2016?
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What do we need to believe?
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What do we need to know?
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What are the roles of staff at all levels?
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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
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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.
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)
What You’ll Learn
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
