Duration
2-day
Training Venue
WCCQ training centre in Kowloon Bay, Hong Kong
Language
Cantonese supportive 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 risk management systems approach for medical device industry and the requirements of ISO 14971, and to provide solid information for students toward risk management system for medical devices. On completion, successful students will be able to:
- Understand and explain the process and benefits of a risk management system for medical device industry
- Understand and outline the structure and content of ISO 13485 and its relationship with regulatory requirements of Medical device industry.
- Understand and explain the relationship of risk management toward quality management system requirements of ISO 13485.
Course Outcomes
Understand the ISO14971 standard;
Understand the hazards associated with medical devicest issues;
Explanation the clauses of ISO13485
Content
Background of ISO14971 standard
Introduction of risk management and medical device risk management system and its core concept
Explanation of the requirements of ISO14971, including risk management policy, planning, risk identification, evaluation and control, residual risk acceptance, and post-production information etc.
Guidance on the development of risk management report
Assignment
Participants
Individual who participate to the risk management team and required for developing risk management process for medical devices
Internal Auditors of ISO13485 and ISO14971
Individuals involved in product design, production, sales, quality control and other operation processes in medical devices supply chain
Pre-requisites
Knowledge of ISO13485 quality management systems
Knowledge of design, production, quality control and uses of medical device
Important Notice
On-Site training quotation is available - please feel free to contact us at shirley-sl.chan@wccq.org for an on-site proposal. We respond to inquiries, then prepare and return quotations, generally, on the same day.
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