Duration

2-day

Training Venue

WCCQ training centre in Kowloon Bay  (Hong Kong)

Language

Cantonese with Chinese / English materials

Description

This course aims to provide students who have an existing basic knowledge of, or experience in, medical device quality management. With an understanding of the management systems approach and the requirements of CMDCAS, and. To provide a solid information for students to become ISO13485 internal auditor under the CMDCAS program. 

Learning Outcomes

- Understand and explain the purpose and benefits of Canadian Medical Device Regulation and their requirement toward medical device manufacturer

- Understand and outline the structure and content of ISO 13485 and its relationship with Canadian Medical Device Regulation.

 - Understand and explain the specific quality management-related requirements of ISO 13485 under CMDCAS program. 

Agenda / Content

- Regulatory Structure of Canada

- Introduction of Canadian Medical Device Regulation and its core concept

- Explanation of the requirements and relationship of ISO13485 under CMDCAS, including risk management, design and development requirements, process validation requirements, vigilance system etc.

- Guidance on the benefits of building on foundation for internal audit of CMDCAS

- Assignment (this course is 50% activity base)

 - Delegate Assessment 

Participants

The course is intended for all those - Medical device quality professionals with knowledge of quality management systems and ISO 13485

- Individuals interested in conducting first-party or second-party audits related to CMDCAS

- Individual who interest to develop medical device quality management system within company

 - CMDCAS Internal auditors

Pre-requisites

The students are recommended to have the following prior knowledge before attending this course:

- Knowledge of ISO13485 management systems

- Knowledge of medical device quality management, consisting of:

- A basic knowledge of the concepts of medical device quality management and the relationship between quality management and related regulatory requirements

 - A basic understanding of medical device knowledge or working on the medical device industry. 

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) 2110 8492.

Remarks

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