The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area where lots of questions float around. The regulation is clear. it states As Far As Possible(AFAP). What is considered AFAP? and how far do you have to go to prove AFAP? and how do you prove that you were able to reduce risk AFAP? Any thoughts?