I think that using a different material can definitely cause a change in the product classification of a product. The overall impact of the material being used depends on what the material being used...

I don't think there are any risks involved in performing validation and verification, rather performing validation and verification reduces the overall risk of the project by ensuring quality and that...

I think that the quality plan is important because the quality plan defines how quality can be achieved in a project. Quality plans determine a plan for meeting relevant quality standards and maintai...

In the case of an implant coated with antibiotics, I would guess that the FDA would designate the product as a device because its primary mode of action would be as an implant, not as a antibiotic. Th...

I think that Fitbit and other fitness wearables don't fall under devices to be regulated by the FDA. The reason being that they aren't truly medical devices as they don't make any medical claims. As...

I agree that it would be unethical for a company to embellish their product to try to get it classified as a type II device rather than a type III device because of the large risk associated with clas...

I think that a balance of the two skills is needed and agree with 85:15 ratio of interpersonal skills to technical skills. I think its important for biomedical engineering students to focus on techni...

I think that the primary mode of action of the digital Abilify pill makes it a drug, rather than a device. This digital pill is more of a pill that comes with a sensor than it is a sensor that comes ...

I think that the priority of a project plays a huge role on the resources that are devoted to the project. The priority of the project will likely depend on how much the company can benefit from the ...

When it comes to severance agreements a company would want your signature agreement on the separation, even in the case of at will contracts to limit the legal issues you can take. I believe most sev...

I believe that written contracts are favorable to verbal contracts because of how much easier it is to enforce and defend that contract. With everything written out, anytime a potential issues regard...

These restrictions do seem very harsh, but I believe that they are necessary to maintain an ethical business environment. In the case of not being able to pay for dinner for the physician's wife I th...

I think completion between teams can often be beneficial as long as that completion is healthy and friendly. The key I believe in staying away from negative completion is strong communication and col...

My current position is in a functional organization where each department team has a functional manager to whom other team members report to. I think this style work well for us as each department ne...

I think I would be more suited for choosing upper management, but I also think I would be able to work in middle management as well. I also agree with the assertion that upper managers should spend t...