ISO13485:2016 Medical Devices - Quality Management Systems - Foundation (1-Day) Training

Duration

1-day

Training Venue

WCCQ training centre in Kowloon Bay  (Hong Kong)

Language

Cantonese with Chinese / English materials

Description

To meet regulatory requirements and customer expectations: national regulatory authorities usually strongly recommend the manufacturer’s medical devices have a third-party audited and certified management system in place or even become mandatory requirement. This is a one-day medical device - quality management system training course, to equip delegates with in-depth understanding of the application of ISO13485 and also an understanding of how to start planning of ISO13485.

Training Content

-       Principle, purpose and benefits of ISO13485;

-       Detailed explanation with examples of each clause in the medical devices system ;

-       Major differences between 2003 & 2016 versions;

-       Basic idea of  implementing ISO 13485 into your business;

-       How manufacturers and suppliers eliminate risk of failures, defects & wastage in their processes;

-       Summary &

-       Q&A session. 

Participants

-       Anyone who works as quality assurance officer in medical devices industries;

-       Interested in implementing ISO13485 into their businesses

-       Ideal as refresher course

Pre-requisites

General awareness of ISO13485:2016 and experience in a medical device manufacturing environment is desirable.

Learning Method

Lecture, case studies and assignment

Contact information

For further information or discussion on analyzing and meeting your training needs please contact us at certificates@wccq.org or (852) 2157 8550.

Remarks

# Onsite training Quotation only: please contact us for an on-site proposal. We respond to inquiries on the same day.