It is important to understand the process of Risk Management which includes Risk Analysis and how this is a living process that flows throughout the entire medical device development process. For more training on this, I recommend this course on medical device Risk Management.

The hint is in that link. What is the major ISO regulation governing Risk Management and what are its major requirements for a medical device company? There are some key things that each company must set up in order to be considered to have a risk management process.