As you guys have mentioned, the project proposal is the heart of the initial project. It is meant to be a short, insightful look into what the device will be about, its cost, and why it should be crea...

I think that the process of V&V, with the many years of re-evaluating, has become a lot more streamlined than it was previously. Although it can be cumbersome and add on time if issues come up, it...

I think that the process of V& V, with the many years of re-evaluating, has become a lot more streamlined than it was previously. Although it can be cumbersome and add on time if issues come up, i...

I agree with krp67 -- the question of why is very important when it comes to any sort of development. Why is something being created? Why must it go through quality? Why did other companies fail at ce...

It makes sense that the customers for medical device companies would be hospitals/doctors and not actual patients. Companies need to sell their products in bulk and that isn't really a possibility whe...

Reply to: ap962 Its interesting that the FDA is so much more stringent with medical devices in comparison with other countries. However, there are aspects to these fields in which other countries were...

I agree with wms7 -- the pill's primary function is to cause changes in the body biologically and therefore, it would be assigned to the CDER. The sensor does not make actual changes to the body and t...

The ideal version of a project manager would allow the person to be able to work across the board of industries, regardless of their technical knowledge. PMI is the sort of organization that helps to ...

At my previous jobs, which were not in the medical device industry, the lines of communication were relatively open but not always utilised to the fullest. * What sorts of project management software ...

If there were more coatings then there might be more options to what the clear choice may have been. Perhaps coating C could have garnered quicker results, such as coating A, but without the stress de...

I agree with smk45 -- technical skills, for a student, are a bit more important than they are for the average professional. As a student, its hard to get your foot in the door because you need to show...