This entire scenario would pose a huge mess because since the failure is vital to the product’s intended use. I think that the possibility of this fai...

Before outsourcing, the project manager should do a cost analysis to determine if doing this inhouse would save time, money, and man power. If not the...

As mentioned in the lecture, it's easier to address changes at the beginning stages of the project. In order to meet all customer needs, I believe mar...

The purpose of the design validation is to confirm that the product's intended use is what it's designed to be. Not just the product, but whatever the...

I think the most important part is determining what the root cause of the failure is or else every solution you come up with will just be a bandage so...

I believe that the system is okay as is. I believe the ability to approve medical devices based on predicate devices speeds up the process of approvin...

I believe that all products go through a decline cycle. I'm thinking how technology seems to evolve in terms of phones. Phones themselves are always i...

I believe that verification of the product comes first and is followed by validation. Verification I would think happens towards the middle or after t...

Functional organizations initially sound like the better organization because hierarchy is clear cut and you can foresee where you have the opportunit...

Business and market research play an important role when initiating a project idea because you want to make sure you are meeting the needs of your mar...

It is not in the best interest of any company to try to deceive or commit fraud in classifying their device as it taints all future submissions to the...

Hi Everyone, My thoughts are that a risk assessment and market discovery would have to be done. Is there a large demand for this new device and do the...

Though it is important for a project manager to be multi-skilled, have strong communication skills, technical knowledge, and risk management skills. T...

Hi Everyone, Growing up it was always emphasized the importance of doing well in school and personally not much was said on developing interpersonal...