To me, risk/benefit ratio for a company mainly comes down to money. For any company that wants to create a high quality product, cutting corners should be kept to a minimum. However, there are certa...

After last week's focuses on the phases of a project and design controls. This combined with FDA regulations lays out a very strict process for which a medical device is to be created. This week's f...

I would say that even if the product itself is okay, something such as missing information on a label can still force a recall. If, for example, a drug label is missing an ingredient and a patient ta...

The company should absolutely go for the project and here's why: Grants are not solely limited to academic institutions and non-profit companies. A for-profit company also has the ability to apply fo...

One of the biggest disadvantages to a project team is that the people within the team can cause a poor culture to form within the group. More importantly, as stated in the notes, projects run well af...

On top of evaluating market appeal for a certain product, I believe one of the most important parts of the project proposal is the implications it can have on regulations. Obviously the more complex ...

Changing the material of the product can definitely change how the project is classified. Even though the syringe designs may have the same design specifications causing one to say they are similar p...

According to Daniel Goleman, success can be broken down to be 70% interpersonal skills and 30% technical knowledge. The idea of this balance being in favor of interpersonal skills is not what I am que...

I think the definition for a project and the experiences you have listed actually complement one another. What I mean by this is that in the beginning a project created with the criteria listed as ha...

I think we can all agree that all those responsible for a project, ranging from the upper management all the way down to "lowest level" employee needs to be on the same page requiring transparency and...