Dr. Simon, I enjoyed your course. Prior to taking this class I don't think I ever wondered the role of a project manager or how medical devices were ...

As an educator, I think the upper and middle level positions that would correlate with those in the school system would be principal (upper) and assis...

I felt most drawn to the matrix organization. The reason I like that format is because it is more collaborative in nature than the functional and proj...

For low severity I would choose: Acceptance - I may have very little to lose with this option. For high severity I would choose: Avoidance - I would...

Some risks must be accepted when considering what the device is, but I think that tends to be when the job cannot be done without that device. For ex...

I currently do not work in the medical device field, so I do not have to entertain risk management from that vantage point, but I have had to work thr...

Design Controls are essential to ensure medical devices are properly designed from start to finish. As Dr. Simon mentioned, it is not appropriate to ...

I tend to be a writer. At all meetings I attend, for personal reasons, you name it -- I am always engaged in some sort of note-taking. It tends to b...

The profession of CRA is one in which I considered applying. Most of the positions all required some background/ experience. While I understand the ...

You are correct, there is a lot of risk that is inherent with drug trials. At present, the proper explanation and consent from the participant seems ...

I agree with your viewpoint on affirming a patient's right to participate in a trial at his/ her own risk. Consent and transparency are paramount. I...

One thing I would do is find the reputable, well-known and respected members of that community and speak with him/ her about the plan. If that person...

I decided to participate in this thread to see the responses and bring a slightly different perspective. Perhaps what I will share may have some simi...

I also hav never looked at a company's financial history, but I have done my small share of research prior to applying for a position. My background i...