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 time. If you are good at managing your time it's ...

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 think I have a bit of experience with a middle mana...

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 begining of the capstone project choose a person fr...

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 then I knew before. I learned a lot from this clas...

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 in India and he told me the stories about things ...

Personally, I think written agreement is definitely better, because the verbal agreement needs proof of people being there or a video recordings. These proofs can be changed with the current technolog...

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 are met. The user needs are to make sure that user ...

I think FDA wants to know if the medical device companies are following the Design Control procedure and have valid design control procedure. They need to make sure that this companies have valid prot...

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, because as an industry if you miss even a small thing, i...

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 do is the set up the start date and the end date o...

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 always look back at it to know what happened in the ...

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 tests you perform as long as you consider all possibl...

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 analysis. 2) The one with the medium severity should be ...

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 of making product because people will pay more mo...

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 find different issues that the whole clinical proces...