Understanding IEC/EN 62304 Requirements (1-Day) Training

Duration

1-day

Training Venue

WCCQ training centre in Kowloon Bay  (Hong Kong)

Language

Cantonese with Chinese / English materials

Description

IEC / EN 60601-1: 2012 – ‘Medical electrical equipment – Part 1: General requirements for basic safety and essential performance’, requires that software within an electrical medical device meets the requirements of IEC /EN 62304. This is one-day training targeting to provide participants the undersanding of IEC/EN 62304 requirements, helping them to understand how they can comply with IEC / EN 62304.

Learning Outcomes

To provide the IEC/EN 62304 requirements awareness training to enterprises, helping them to understand how they can comply with IEC / EN 62304.

Course Content

- Overview of IEC/EN 62304 requirements

- Overview of Risk Management for software

- How to apply IEC/EN 62304 with IEC/EN 60601-1

Participants

Person are auditors of medical device manufacturers (software)

Quality managers

Person are evolving in the medical devices (software) manufacturing

Pre-requisites

General awareness of ISO13485:2003 / IEC/EN 60601-1 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) 2110 8492.

Remarks

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