This course really opened my eyes to how the world of medical devices really operates. As a biomedical engineering student, most of my education was f...
In its simplest form, an NDA (Non Disclosure Agreement) is a legally binding contract that creates a confidential relationship between persons holding...
Although it is possible to begin a project based on a verbal agreements, it is still a very informal method of commitment and is not effectively reinf...
The main goal in this type of situation is to find an organizational structure that both parties can agree on for the duration of the collaboration. C...
My workplace consists of a matrix organization in which resources are split based on project priorities. Project managers are able to share the skills...
In a company setting, it is easy to work with people that we have cordial relationships with since everyones goals are aligned. After that, its a matt...
I don’t agree with this reason. For an effective product design, I believe risk management and design controls should occur in parallel to one another...
Strict regulations allow for enforcement agencies such as the FDA to filter out companies that are dedicated in meeting regulatory standards along wit...
Depending on the situation or the environment in which a medical device or drug is used, its cautionary labels may not always work effectively. As Dr....
The largest source of design input is market research. Understanding the market gap for your product can help to understand what services need to be f...
DDPs as a whole are very crucial in the timeline of the project. The gantt chart helps to outline each segment as it is approached. The project manage...
Although I've never attended a design review meeting, I think it's safe to say these meetings are crucial to get every member of the team and even spo...
Placebo controlled trials are a great way of helping scientists understand why a new medical treatment is more useful and effective than no treatment ...
In most cases, double blind studies are an effective way of performing a research study and learning new information about a drug or new treatments. D...
A background in clinical studies should be required depending on the profession and work environment. For example, a Principal Investigator (PI) is th...