I think that it is important to note that the safety recalls and inadequate testings are mainly from products that have not reached the patient yet. T...

I feel that when considering this 70% interpersonal skills and 30% technical knowledge ratio, you need to consider the job that it is being applied to...

I am currently working as a coop at Getinge and I feel that my company is a functional organization. There are separate groups within the organization...

A good project manager should have great interpersonal skills. As was mentioned in the lecture, the success of a project manager is based on 70% inter...

Dr. Simon, I really enjoyed taking this class. I feel that I learned a lot, especially while working on a co-op in the industry. This coursework comp...

I agree with the above statement, that this rule needs to be enforced. Expense paid dinners can be taken advantage of, not only by the employee but ev...

I would stretch the limits of oral agreements to include texts, emails, and meeting minutes as binding. While written agreements are more of a formali...

For a startup company, I would probably choose a Project-based organization. Since the startup would be focused on only one product, having a team of ...

I definitely agree with the above comments by amd29 about how communication is the main source of conflict within a matrix organization. I have been p...

I feel that Matrix Organizations are the most efficient organizational structure for the medical device industry. This style best manages the company'...

It was mentioned above that in the operating room, the surgeons and the technicians are not reading IFU's and packaging labels. Those are meant to be ...

Risk factors are occurrence, severity, and noticeability, as said in the lecture. I think another factor that can be used to assess risks are conseque...

For low severity risks, I find that acceptance and transference are the best options. Since it is a low risk, you may as well just take the risk upon ...

I have not been part of or viewed a design review meeting, however, I feel that these meetings are essential for production. As processes, procedures,...

Design controls are important in order to have a reproducible process for medical devices. The nine parts of design controls are all important to main...