Despite the high opinion in which ISO 14971 is held, and despite ISO 14971 stating flatly that "The criteria for risk acceptability are essential for the ultimate effectiveness of the risk management process", most companies not only do not have the policy required by ISO 14971 to establish criteria for Risk acceptability but they also have no idea how to defend a policy that they may write in the future.  If you are with such a company, then this presentation is for you.  If you have a policy to establish criteria for Risk acceptability but are unsure how to defend this policy, then this presentation is for you. 

We will review a policy for establishing criteria for Risk acceptability that is grounded in regulatory guidances and discuss how this policy can be used to tailor the criteria for Risk acceptabiligy.