Activity

  • dfn3 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 9 months ago

    I do understand what you and Dr. Simon are saying but I get confused when it comes to situations the company cannot control. For example, medicines such as Tylenol or Advil are sold to the “normal” public which are not usually a group of pregnant women. So it should not be the top priority of a company to make Tylenol safe for pregnant women to use. So the way the company addresses this risk is that they use a label and say that pregnant women should not use this medicine. Now if a pregnant lady does take the medicine how is that the company’s fault. They put the warning label and it should not be their top priority to make sure Tylenol is safe enough for pregnant women.