Description
This course is designed to provide participants with an understanding of the impact of ISO 14971:2012 on the decision-making process in medical device manufacturing companies. This one-day training course helps medical device professionals understand how ISO 14971 can improve their business and risk management efforts. Participants will also understand how ISO 14971 applies to ISO 13485.
It includes training exercises and participants will have the chance to ask questions about ISO 14971 and how risk management is applied to their organisation, understanding the impact of ISO 14971:2019 on decision making when manufacturing medical devices.

Process and Achievement
Understanding the impact of ISO 14971:2019 on decision making when manufacturing medical devices.
Will be able to establish the relationship between ISO 13485 (QMS) and ISO 14971 (RM)
Explain the relationship between risk management and product life cycle.
Define risk management terminology
Summarize the stages of the risk management process
Will be able to define key delivery products of risk management process.

Who should take it?
Regulator
Quality
Design (including design changes)
Development
Production
Marketing Managers and Staff
Those who make decisions about management system strategy
Internal Auditors

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