Adding to what Hiren Rana said, not only will the project manager need to allocate more time for R&D. The test protocols may need to revised. This would take more time and causing a delay in the t...

Sharing my research experience, I was doing a computational study on the BCR phili gene. The entire research project was broken down into multiple parts: Computational Data, Analysis, Literature compa...

As Dr. Simon discussed in the lecture of how the Work Breakdown Structure (WBS) can be broken down. There is isn't one way of doing this. WBS do not have to be a certain way. They can be broken down b...

I think Verification can occur anytime during a project. I do not have any industry experience but theoretically speaking Verification can occur at any point. It can also occur during the research pha...

In designing a hip stem implant and running finite element analysis on it last semester. After creating the part file which took hours, and applying constraints and loads on the hip stem implant. Afte...

Not knowing your budget can limit your team members. For example, when you hire people for a project they work at a specific rate. So if you do not know your budget it can be problematic in getting th...

My opinion on this is, SOPs should not be required during the research phase. The main reason behind this is that during the research phase your project can take multiple phases. There could be second...

Agreeing with everyone here, in addition I would say the SOPs should be written so someone with a high school education can read them without any confusion. Also, it varies from project to project. So...

I do not have any work experience in this field. However, from what we learned so far. I would choose the second option you posted. Reason being is the work instructions step. This is vital in any Qua...

As everyone already answered the initial question in full detail. I would like to add why I believe it is important to have post market surveillance. Yes it gives companies feedback and how to better ...

I personally take women's one day multivitamin as recommended by my doctor. During undergraduate years, I was going through extreme stress and anxiety with college courses as well as work life. This r...

My personal experience as a coordinator of a program at NJIT (non-medical). I would prefer a team who actually is passionate about the project. As a coordinator, I am responsible for 50 students and ...

This week Dr. Simon required us to work in a team and solve a problem using our knowledge, research, and other skills. I had the pleasure of working with a great team and everyone has been on point in...

Hey guys, After going through the notes and google, I wasn't really able to tell the difference between a Device history file and device history record. For anyone who has experience in the industry, ...

I have no experience in the industry, but based on what I know about ECO from Dr. Simon's course, I would only use an ECO for profits. For example, if there is a major change that needs to occur in th...