@bryan-xavier @james-olson I agree the user need comes first, but I’m not sure “consensus” works as a threshold. A room agreeing the device works is still an opinion. I think the threshold should be something you can check on paper,…   Read more»

@james-olson I agree that QA is difficult because it is proactive but I would stress that in medical devices QC may not always be a back-up because some processes include barriers, seals, weldings, and sterilization that lead to outcomes that…   Read more»

@james-olson I also had a similar impression as yours and thought that it was mostly quality assurance. After this week’s lecture I feel like it would be difficult to name one particular department, as all are interconnected, and I would…   Read more»