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 designed use. You can't have an implant that is too big o...

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 are agencies such as EMEA, CFDA, ANVISA, etc. tha...

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 verification and validation steps will not pass, so that if...

Most companies invest in potential projects until there are serious signs of non-viability. They spend millions on R&D for that purpose. Every project has the potential to become the next breakthr...

I agree with both zbw2 and alexandra. The FDA establishes minimum requirements in terms of safety and testing. Many companies choose to hold themselves to a higher standard. If something goes wrong, t...

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 known if migrate if left in the body. Whether or not ...

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 devices that have completed phase I testing but hasn't...

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 the product people can become very sick or die. The...

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 good handle on both in order to be effective. Know...

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 that $100 is a good cap, and limiting it to the phys...

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 wish we could have gone a little more in-depth but w...

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 assumption of it being an verbal agreement. Howeve...

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 percentages, let's say 70/30. You can people who hav...

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 management gets promoted from middle management. You...

Personally I believe I would rather be in a functional organization. I like clear cut positions and knowing how to advance. Interdepartmental coordination shouldn't be as much of a problem compared to...