Found sometime ago a great article: Product Liability Insurers Raise The Bar On Risk Management. It´s from The Grey Sheet, a journal/website from Elsevier directed at medical evices regulatory community.

I think there´s one phrase in the article that summarizes it´s intention, and it´s a phrase i totally believe and try to spread:

“Companies get lulled into believing that if they get that FDA stamp of approval, everything’s going to be fine”

This is true in relation to every regulatory requirement from every regulatory agency. The fact is that manufacturer sometimes forgets or try to get away from the fact that THEY are responsable for their devices, not any goverment or regulation.