The necessary steps to take in order for a combination product to get FDA approval is to first find out what is the main purpose of the product itself. I just want to highlight how important it is for a product to identify its main functional requirement. There were a couple of examples from lecture of how there can be a different combination of…[Read more]

If a company were to somehow successfully figure out a method of developing artificial organs for use by patients in need of immediate transplant then I would definitely agree that it would classify as a Class III device. Any devices that support or sustain human life, that are of substantial importance in preventing impairment of human health, or…[Read more]

From my experience so far as a Mechanical Engineer for my company, I believe my company would be closest to a weak Matrix-based organization structure. A Matrix-based organization means that reporting relationships and collaboroations are set up in a grid rather than the traditional hierarchy of management. So employees are constantly…[Read more]

From my experience so far as a Mechanical Engineer for my company, I believe my company would be closest to a weak Matrix-based organization structure. A Matrix-based organization means that reporting relationships and collaboroations are set up in a grid rather than the traditional hierarchy of management. So employees are constantly…[Read more]

From my experience so far as a Mechanical Engineer for my company, I believe my company would be closest to a weak Matrix-based organization structure. A Matrix-based organization means that reporting relationships and collaboroations are set up in a grid rather than the traditional hiearchy of management. So employees are constantly collaborating…[Read more]

As an entry level Mechanical Engineer straight out of college, I’m still learning how project management comes into play into the overall company’s work day. Along with my current job and my prior internship that dealt with the design and verification testing of LED lighting fixtures, it seems project managers aren’t really your traditional type…[Read more]

Along with superior communication and proper planning, I believe what can really help in the average work day for a Project Manager would be excellent organizational skills. While good organization would be good for Project Management, it’s a skill that would help almost anyone that’s in the workforce. From prior experience from internships in the…[Read more]