Understanding ISO14971:2007 Medical Devices - Risk Management Requirements (1-Day) Training

Duration

1-day

Training Venue

WCCQ training centre in Kowloon Bay  (Hong Kong)

Language

Cantonese with Chinese / English materials

Description

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. This is one-day training targeting to provide participants a knowledge of ISO14971 risk management to medical devices and also they can understand how ISO14971:2007 applies to ISO13485:2003.

Learning Outcomes

To provide the ISO14971 requirements awareness training to enterprises, helping those companies how to review and achieve certification in comprehensive way, as well as to meet regulatory and customer requirements.

Course Content

- Medical device - risk management system overview

- In-depth explanation the clauses of ISO14971

- Understand how ISO14971 applies to ISO13485

- Exercises and case studies

Participants

Person are auditors of medical device manufacturers

Management team of medical device

Person are seeking management system strategy at medical device

Pre-requisites

General awareness of ISO13485:2003 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.