HKQAA 香港品質保證局

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)