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...

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...

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...

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....

The only medical devices used outside the body that likely wouldn't need clinical trials are probably low risk devices where there are already substan...

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 th...

In most cases I believe validation and verification may be necessary especially in medical devices. Verification and validation together prove that a...

I think design input can come from many sources including customer/client requests or observations, team members raising their own observation. Desig...

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 s...

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 ...

I think that placebo controlled studies are ethical and also very important in clinical trials. Placebo studies are important to the study because th...

There are positives and negatives about clinical trials, but I think that clinical research is important and needed in medicine and treatments. The b...

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 wh...

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 ...

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