NDA, Non-disclosure agreements, can be used when discussing your idea with other person and when you don't what that person to tell it to other people...

I believe that company will involve outside consultants when they don't have anyone who can fulfill the role or a department or when they think they w...

I am glade that I took this course because it covered how development of medical device works and gives incite into what biomedical engineers do. I li...

In my opinion matrix organization because you will get chance to get to know lot people and also because you can learn new stuff as you will be workin...

I would prefer matrix organization as you will get chance to get to know lot people and also because you can learn new stuff as you will be working wi...

In an industry you don't get to chose who you work with because it depends on the management, who assigns members to project. Forming a perfect projec...

For the low severity you can try to choose avoidance but if the design of the product is changed to the point where making anymore changes will contra...

For risk management meeting you have to make sure that project members know for which device you guys are having meeting for and intended use and desi...

I agree that labeling should be the last resort as people don't generally read label. If your product is designed the way that you have mitigated most...

Design controls will have all the nine parts mentioned in the lecture, planning, input, output, review, verification, validation, transfer, design cha...

I believe gantt chart requires estimated timeline of the project, phases of the project, how each phase is related to each other, and members who woul...

Pros of outsourcing manufacturing process would be money and knowing your product is being manufactured by a good manufacturing company. Because it wo...

Design inputs require you to have knowledge of how the device will function. This depends on the design, shape, and what the device is made to do. Des...

Meeting minute are import part of meeting when you are discussing something important because they let you see what you talk about in the meeting so e...

Design controls are FDA guideline which you need to follow when you begin creating your device. This guidelines help you understand weather your devic...