I know a lot of folks in the medical field, and unfortunately the medical industry is riddle with kick backs. Just about all company's are guilty of t...

It's not so easy to come up with a name due what the class covers. With that said, I would say something along the lines of "Medical device developmen...

I thought this course did a good job of covering the key areas of the medical device industry, in additional to how people work within the industry. T...

Based on my experience, I disagree with those that say corporate culture can change in the blink of an eye. This is usually the hardest to change, and...

I have worked on several projects like this before with some good and bad outcomes. From an engineering point of view, this can be a pain if the work ...

Hi, In one my past job, I worked in a "Self directed cross functional team", which I enjoyed and saw as having many advantages.This included creativit...

I agree that sample size is critical to any project. I don't have any industry experience with sample size related to risk analysis, however, I was ab...

Another method: Event Tree Analysis (ETA) It is an inductive failure analysis performed to determine the consequences of a single failure for the over...

I had the experience of sitting in on a couple of risk analysis meeting, and this is early in the process when the team are trying to determine if the...

There are always pros and cons with outsourcing, however, this is not really dependent on the size of a company, but more so to do with time, cost or ...

Meeting minutes are an extremely important part of any project, without this your project will easily failure. The bigger the project to the more impo...

I agree with most of that the FDA doesn't demand specific test and to me this would be too much of an overhead and additional unwanted burden for them...

Design inputs can and will come from various sources. Depending of the type of design, input can come from the customer, market research, feasibility ...

I agree that all the parts are very important, however, I have to disagree with you on this point, that the communication management plan is the most ...

Fady, This is a very interesting and also important subject matter. To answer your question, even products that were designed and built pre 21 CFR, ha...