I have been a part of matrix organization and I have to say it does get bit messy to work, especially when you have two different projects due at same...

I think I can probably do both of the described position. However, I definitely need more expereince before I can handle upper managment position. I t...

I think its definitely better to work with the people who have more knowledge on their department. As Dr. Schesser has metioned several times in the b...

Even though, I don't really have any experience with a big medical device companies I think I can say that I know much about medical device world now ...

I think it makes sense that these rules are being placed. you might consider it little too restrictive, but they should be placed. My dad was a doctor...

Personally, I think written agreement is definitely better, because the verbal agreement needs proof of people being there or a video recordings. Thes...

A successful validation process will make sure to follow all the company and the FDA rules and will ensure that the user needs and the company needs a...

I think FDA wants to know if the medical device companies are following the Design Control procedure and have valid design control procedure. They nee...

I agree with what you have to say about the design verification. It is absolutely necessary to verify design before it goes out for production, becaus...

Again, I don't have any experience on making gantt chart for a company, but I have made gantt chart for my capstone class. I think the first thing to ...

I have been to few meetings, where minutes are taken, this are really important especially if you are forgetful or busy in general, because you can al...

I did some research on FDA website for this class and before in capstone class and the one thing I found out is that FDA doesn't care what type of tes...

I think it should go like this: 1) Hazards that fall into a low severity risk, are considered generally acceptable and will not require further analys...

I think as far as possible, is what is literally should be, because the human life is worth more than anything. We shouldn't worry too much about cost...

I would prefer to be clinical quality assurance, because it gives me chance to go over complete process. It also helps me find different process or fi...