In my opinion, it would be more difficult to be a project manager in a Matrix-Based Organization. In a matrix-based organization, project managers and functional heads must negotiate to have people wo...

I would prefer to work in a matrix-based team because of the knowledge transfer from project to project and between departments. I like to understand everything that is going on in the entire project ...

For my project, I believe a project-based team is in place. I had to leave my original project team because there weren't enough people in the class to fill the remaining roles. Now, in my project tea...

Risk acceptance does not lead to a higher probability of risk. When you are accepting a risk, it means that the team has done all they can to mitigate the risk. There comes a point where the team can’...

I have used FMEA before in my role as Mission Assurance Specialist for a NASA Workforce Development Program. I find it very helpful when doing risk assessments because it has all the necessary informa...

As part of my job, I am required to attend various safety training sessions to use different equipment. As part of Radiation Safety Training, I heard the importance of covering any radioactive materia...

DIDs and DSDs are living documents, which means that if an error is found, it can be corrected easily. Since DIDs and DSDs are always being changed and reviewed, an error that is found early on may be...

Minutes in a meeting are extremely important because they can give deadlines for projects and assignments for certain tasks. Everyone must read the meeting minutes so they are up to date on the status...

This is a really good point about the updating process of living documents within the medical device process. I think organizations can balance maintaining up-to-date documentation while preventing in...

For my capstone project, my group and I created a wound healing hydrogel for cutaneous wounds. The main issues in design and development were the design of the mold used to shape the hydrogel (this wa...

I don’t think that there is ever a time when a team decides to log more inputs for predictive measures. If they did that, they would have to log more outputs. If the team has more ideas of possible ri...

I am not aware of any companies that encourage their employees not to record unsuccessful instances associated with the medical device in the verification report. If a company does do this, when they ...

If patients are being rewarded for being tested on, the researcher may take advantage of them and perform unethical experiments. Patients have the right to leave the clinical trial whenever for whatev...

In my opinion, the placebo effect does not have negative effects on a clinical trial. The placebo is the control, which is compared against the actual drug/medication that is given. If a patient in a ...

AI use in clinical trials can introduce bias into how patients are selected and who is chosen, and this is because humans make AI using their own biases. This affects the reliability of the trial resu...