ISO13485:2016 Medical Devices QMS - Requirements for Regulatory Purposes -
Understanding & Application
Course Objectives
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Understand the principles, definitions, requirements of ISO13485:2016
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Appreciate the actions required to establish a quality management system for manufacturing of medical devices
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Aware of tools and techniques which can be applied to manage risks
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Understand the preparation for certification
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
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)
