As stated by previous responses R&D would be a factor that extends the Gantt Chart and timeline of the project. However, another important aspect ...

A critical path I identified occurred during the R&D phase of a project I was working on before it became a formal project. We were working on cre...

Within our company a project we started last year needed a good amount of information before we introduced the idea for a formal project. First off we...

A budget cut as stated by the previous posts is a critical factor in project management. While planning under budget is a good idea for any project it...

For the specific scenario that was given by Dr. Simon I think that working face to face would've solved the problem with one or two conference meeting...

One basic example of a general wellness product would be the recently released amazon echo dot. The echo dot has many functionalities and can be consi...

I agree with the posts above that fitbit should not be classified as a medical grade device because it's purpose is not to be used as a replacement fo...

Initiating the project is a crucial part of the project and the hardest step in initiating the project is the business and market research. I think th...

Validation and verification as stated in the lectures are both independent procedures used to establish that the product meets specifications/requirem...

I agree with what everyone else has said, that the thalidomide crisis played a pivotal role in shaping the regulatory authority of the FDA and creatin...

Although both have similar end goals, mainly that of ensuring successful completion of a project. I agree with Shachi in that there is a significant d...

This is an interesting topic and one that goes through considerable research when launching medical products. Personally I have some experience with t...

A brief history of this loophole begins with the creation of a regulatory agency for the benefit of the United States Populace. -Medical devices cam...

I work for Ethicon Biosurgery and they are a subsidiary of Johnson and Johnson. The company's project management awareness is advanced, however it is ...