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 so when you go to patent it you don't have to wor...

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 will require professional input by a consultant who...

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 liked how this course covers about different aspects...

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 working with people from different departments. By being...

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 with people from different departments. By being in ...

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 project team would involve having good relationship with...

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 contradict with the initial function of device then I wi...

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 design of the device. Then you have to make sure to wr...

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 of the risk that can be mitigated to ensure produ...

Design controls will have all the nine parts mentioned in the lecture, planning, input, output, review, verification, validation, transfer, design changes, design history file. Design controls help co...

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 would be working on each phase. Gantt chart lays out t...

Pros of outsourcing manufacturing process would be money and knowing your product is being manufactured by a good manufacturing company. Because it would be expensive to manufacture devices in house b...

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. Design inputs are base for the device you want to cre...

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 everyone is on the same page. When developing new d...

Design controls are FDA guideline which you need to follow when you begin creating your device. This guidelines help you understand weather your device is safe to release into the market. It is way ea...