Course code
FD133
Duration
7 hours

This course provides a basis for learners who wish to go on to complete CQI and IRCA Certified MD-QMS Auditor Training courses

This course provides learners who have an existing, basic knowledge of, or experience in, quality management in the Medical Device with an understanding of medical device risk management and the requirements of ISO 14971.

Recommended Prior Knowledge

Risk management

  • The fundamental concepts and principles of risk management as it applies to medical devices 

  • The commonly used risk terms and definitions (see ISO 14971)

ISO 13485 :2016

  • A working knowledge of ISO 13485:2016, which may be gained by completing a CQI and IRCA Certified MD-QMS ISO 13485:2016 Foundation (FD132) course or equivalent

Who is it for? 

This course is for those requiring an introduction to ISO 14971, especially those involved in the risk management of medical devices.

Learning outcomes 

  1. Explain the purpose of medical device risk management system, of medical device risk management standards, and the role of risk management throughout the lifecycle of the medical device

  2. Outline the structure and content of ISO 14971 and its relationship with ISO/TR 24971, product safety standards, medical device management system and regulatory standards

  3. Explain the requirements for establishing a risk management process based on ISO 14971

Assessment

Learners must demonstrate achievement of the learning and enabling objectives in accordance with the ATP’s defined learning evaluation methods and the CQI’s assessment requirements.