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 life cycle process of Medical device software IEC62304, and. To provide a solid information for students to become medical device software internal auditor.

Learning Outcomes

- Understand and explain the purpose and benefits of IEC62304 Requirements toward medical device software

- Understand and outline the structure and content of IEC62304 and its relationship with ISO13485.

- Understand and explain the specific quality management-related requirements of IEC62304

Agenda / Content

- Overview of Medical Device software life cycle

- Introduction of IEC62304 and its core concept

- Explanation of the IEC62304 requirements and its relationship to ISO13485 and ISO14971, including risk management, software development process, change and configuration management 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 in understanding on software life cycle requirement in medical device industry

- Individual who interest to develop software that conformance to IEC62304 requirements within company

- IEC62304 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 software and medical device quality management, consisting of:

- A basic knowledge of the concepts of medical device quality management & risk management and the relationship to regulatory requirements

-  A basic understanding of software that apply to medical devices.

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.