I mostly agree with what what said above. I believe there is a hierarchy of importance. First, the device needs to be within tolerance of it's designe...
For most companies in the BME industry, they operate globally. This means that they have to adhere to all of those nation's regulatory agencies. There...
I feel like the point that verification/validation will not always pass needs to be brought up more. Companies need to keep in mind that the verificat...
Most companies invest in potential projects until there are serious signs of non-viability. They spend millions on R&D for that purpose. Every pro...
I agree with both zbw2 and alexandra. The FDA establishes minimum requirements in terms of safety and testing. Many companies choose to hold themselve...
Well this is an interesting point. Acupuncture has been done for centuries, so safety doesn't seem to be a concern. However, the needles have been kno...
May 2018 saw the signing of the "right to try" bill into federal law. It allows terminally ill patients to try experimental drugs, biologics, and devi...
A missing or erraneous label means that the product can not and should not be used. FDA regulation is strict for a reason. If anything is wrong with t...
I'm not a fan of giving either percentages of importance. It may differ from situation to situation. Of course, both are important. You need a have a ...
It is a tricky subject. On one hand kickbacks are an obviously bad thing. However small gifts are good ways to start/improve relationships. I think th...
This course has been really useful, and I know I'll be looking back at these forums and documents in the future. The information is well rounded. I wi...
I noticed that no one talked about a recorded phone call/video call. I'm not sure which it would count under. Technically its not written, pushing my ...
As stated you don't usually get to choose. That being said, I think you need to lean on the knowledge vs compatibility side. For the sake of giving pe...
I don't think that it matters if you want to be upper management if you're bad at middle management. I may be wrong, but I'm pretty sure that upper ma...
Personally I believe I would rather be in a functional organization. I like clear cut positions and knowing how to advance. Interdepartmental coordina...