I agree with the above post but, I think the criteria in general have to be further explained. If you look at the requirements from the site all of them say "serious risk". This brings up the question...

I would agree with the above posts that an artificial organ would be a class III device. Class III devices are typically the ones that pose the greatest risk to a patient and as you can imagine an art...

I agree with pretty much everyone on this post regarding the fact that your device would be considered a mobile medical app. The fact that your capstone project actually served as a method to TRAIN us...

After working at Zimmer-Biomet and Stryker, I realized that they were both functional organizations. This means that that organization is divided into groups for different specialized functions (IT, R...

Current Good Manufacturing Practices (cGMP) are systems in place that ensure that a product is being made according to current regulations. This means that it meets quality standards, production stand...

Overall, I believe that project management ultimately depends on the way you look at the project, whether it is the same industry or within several industries. While all projects follow the same PDCA ...