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 failure or a failure occurring and setting back the p...

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 then before outsourcing the project manager should en...

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 marketing, engineering, manufacturing, and representa...

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 project is. For example, during my internship 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 solution. Temporary solutions won't fix the problem ...

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 approving necessary devices for the population. This is a ...

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 in high demand and the use of phones has actually 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 the midpoint of the project development and is foll...

Design controls are like a system of checks and balances to help comply with the law and ensure safety. For those that work in industry what part of the design control process have you had a chance to...

Functional organizations initially sound like the better organization because hierarchy is clear cut and you can foresee where you have the opportunity for growth within the company. This could provid...

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 market as well as you want to know there is a market ...

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 FDA if they are even allowed to continue operatin...

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 pros outweigh the cons risk wise? Would it be mak...

Though it is important for a project manager to be multi-skilled, have strong communication skills, technical knowledge, and risk management skills. These can all be encompassed by the single skill of...

Hi Everyone, Growing up it was always emphasized the importance of doing well in school and personally not much was said on developing interpersonal skills. So i'm inclined to initially say that tech...