I would say that the risk of verification and validation is not completing it in the time constraint you had originally planned or not being able to complete it at all and having a project cancelled. ...

I agree and think that there should be more regulation on what patients are being told. If the company is not the one suggesting high intensity and extreme sports be performed then the claims of the c...

For my capstone project during undergrad, my teams project was to improve an ambulatory walker. In order to assess what the user needs were we spoke to the expert assigned to our team. She has worked ...

I think that many devices can fall between multiple sectors. The way I look at it to understand why certain devices go to the Center for Devices and Radiological Health, the Center for Drug Evaluation...

I would say that the Zoll LifeVest is a Class III device due to the fact that it has a high amount of risk. If the device fails there is the possibility of sudden cardiac death. I would think that the...

I do agree with and if there were unlimited resources would like to run all the tests I could since its better to be safe than sorry. In our scenario that was not the case, so I think even though coat...

I would say that the Zoll LifeVest is a Class III device due to the fact that it has a high amount of risk. If the device fails there is the possibility of sudden cardiac death. I would think that the...

I think that they had a "pick your poison" situation. Either end the project and get more out of another while losing the progress made with these half done projects or take the risk to hire more peop...

I think this is a good question and agree that the definitions provided are vague. However, I think that it makes sense for the definition to be vague and the line between significant and non-signific...

I think that the four categories are in order. I look at it as the strategy and tactics that come from upper management are the idea or planning phase. Thinking of what you want or need would be the s...