The 6,500 word, 12 chapter guide walks you through every step of the process and gives specific recommendations on what you can start doing today to ensure compliance and how to use risk management as a tool - not a checkbox activity.
As one of our most popular infographics to date, it aligns directly with the ISO 14971 standard on a one to one basis and is a high-level overview of Risk Management process. This infographic allows medical device manufacturers to establish a risk management process that will identify hazards, estimate and evaluate risks, and develop, implement and monitor the effectiveness of risk control measure.
Many times, it seems like everyone has a different view of the world regarding medical device Risk Management. This guide leaves you with an understanding of what is expected from medical device regulators regarding ISO 14971 Risk Management.
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