Risk-benefit analysis is an important consideration for a product. Part of the risk management framework is to decide what risks that you are willing to take with a product. It is important to ident...

Risk factors depend on variables such as the severity of the risk, likelihood a particular risk occurs and the types of risks that they are willing to take. The severity of a risk can be severe, crit...

I agree that the phrase "as far as possible" is broad and difficult to quantify. Because there is no way of knowing how many risks that may exist but haven't been identified. Because of this it isn'...

All parts are very critical so it is difficult to say which is most important but I'd like to highlight the team member list/responsibilities section. For the project to move slowly assigning the rig...

The only medical devices used outside the body that likely wouldn't need clinical trials are probably low risk devices where there are already substantially equivalent devices on the market such as ga...

In my experience with design reviews during my undergrad capstone we had weekly meetings with an advisor and a customer to discuss progress made in the past week and any new concerns. The meetings th...

In most cases I believe validation and verification may be necessary especially in medical devices. Verification and validation together prove that a product is safe and that it meets its requirement...

I think design input can come from many sources including customer/client requests or observations, team members raising their own observation. Design inputs are defined allowing development to proce...

I took BME capstone during my undergrad at NJIT and the requirements document and test plan documents are both things that I've seen and worked with since I started working. When I worked in a test a...

When I worked o nay undergraduate capstone project in order to get approval to do testing on human subjects we needed to fill out IRB application and present the project and test cases involving the u...

I think that placebo controlled studies are ethical and also very important in clinical trials. Placebo studies are important to the study because they can be compared to the results of the drug and ...

There are positives and negatives about clinical trials, but I think that clinical research is important and needed in medicine and treatments. The biggest negative on clinical trials is the possibil...

A mission statement is a statement where a business summarizes their goals and purpose. The importance of a mission statement is that it speaks to what the company does for its customers and the comm...

I think social media has become the most common way of using participation. Participation is an important consideration along with the 4 P's because a company needs to be able to quickly engage a cus...

Emotional intelligence is the ability of a person to identify their emotions and then manage and regulate their emotions. EI also includes being able to identify the emotions of others and manage int...