I don't agree in using unapproved devices because it is a Hail Mary attempt to treat someone. It could cure but there is a high chance that it could cause more pain. Physicians can enlist patients in ...

I agree with the group that believes validation and verification should be enforce through out the medical design process. During the design process there are documentation and test studies which proj...

Quality plan is very important because as other stated it helps test the quality of the product that is going to be release to the public. There are so many risk that a new product can have and in ord...

Risk management plan is method to reduce any risk a company can suffer. It is a way that the company can avoid/ minimize being sued or even harming the public. Last year I took medical device developm...

I would definitely agree on a recall because it will be the company's fault if one of their product device harms a person. The company is responsible of displaying all warning, healthy issues because ...

This is a tough decision but it will all depend on, will it actually work and help the public because there are projects that will not make it to the public due to malfunction and or delays. There mus...

I think the ratio should be 60% interpersonal and 40% technical. The reason being is that technical is taught in school. Students are trained how to solve problems and how to do research for their pro...

It is very important to pick the right members for a project because they must be able to fulfill their task in order to complete the project. The members chosen must be reliable and have friendly com...

I think a project manager must have time management and communication skills. The reason being is that for every project there are time limit. Project managements are responsible for meeting all repor...

I agree with everyone that both written and verbal contract are important and that written contract is more powerful than verbal contract unless it is recorded because they can searched and found as e...

This is good course for getting experience in the start development of medical devices. This course shows how each department work in the development process of devices and what documents are required...

The difference between NDA and Patents is that NDA keeps a secret between to people and or companies, while patent provide ownership of the device product. I feel that if you are developing a device y...

The way I would create my project group is picking people who I know that will work with well with a team. If I don't know them, I will look for people that have a high communication skills because co...

We haven't had a in person meeting yet but will are scheduled to meet every Thursday. We have been communicating through groupme, text, and by email. All of are documents are being done through google...

I believe that anyone could either middle management or upper management, it will just only depend on their. I would like to be in upper management but unfortunately I don't have the skill set. I woul...