NDA, Non-disclosure agreements, can be used when discusing 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 worry about someone…   Read more»

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 has worked on similar device. Also…   Read more»

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 of medical device development and engages…   Read more»

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 in matrix organization you…   Read more»

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 matrix organization you…   Read more»

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 your coworkers and you and your…   Read more»

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 will choose mitigation or…   Read more»

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 write down what…   Read more»

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 product works the way…   Read more»

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 companies release harmless and useful device because as you follow through all the…   Read more»

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 the roles and deadlines that…   Read more»

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 because you have to buy  costly equipment and manufacturing engineer….   Read more»

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 create as you…   Read more»

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 device it is important to…   Read more»

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 easier to follow this guidelines while…   Read more»

I would prefer sponsors role as they do research on rules and regulations in order to develop protocols. In order for sponsor to start clinical trials they have to follow good clinical practices which involves 21 CFR regulation by FDA,…   Read more»

If people know that there is a possibility that the device or medication they got is not actual but dummy then there are chances of corrupting the results because if they were given the actual thing and they think its…   Read more»

Based on the lecture I think double blind referee to the doctor and patient not knowing which medication is real and which is dummy medication. This study can avoid possibility of doctor influencing the result by being bias. Results obtained…   Read more»

Mission Statement will tell you how the company does business and is more for shareholders and employees.Vision Statement states what company wants to do and what is companies purpose and value.They are important because they define how the company will…   Read more»