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 Europe CE Medical Device Directive requirements (MDD), and. To provide a solid information for students to become specialist on CE MDD.

Learning Outcomes

- Understand and explain the purpose and benefits of CE MDD 93/42/EEC Requirements toward medical device manufacturer

- In-depth understanding the structure and content of CE MDD 93/42/EEC and its relationship with ISO13485.

- Understand and explain the specific quality management-related requirements of 93/42/EEC.

Agenda / Content

- Overview of Medical Device Regulation in Europe

- Introduction of CE MDD 93/42/EEC and its core concept

- Explanation of the CE MDD 93/42/EEC requirements and its relationship to ISO13485, including risk management, process validation requirements, vigilance system etc.

- Assignment (this course is 50% activity base)

- Delegate Assessment

Participants

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

- Individuals interested to have in-depth understanding on CE MDD 93/42/EEC requirements

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

- CE MDD 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.