In personal experience, the design matrix is the most important part of the risk management analysis. The way it was done in a job I had, was by how much money the owner of the company was going to make. He always put pressure on the workers to get things done on time and just have enough quality to pass the tests required by the FDA. It was a…[Read more]

I agree with most of the challenges mentioned above by my classmates. However I have to point out that the main two challenges(In my opinion) should be safety issues and communication problems between all the departments working on the device. 2 years ago, I did a summer internship that dealt with electric installations throughout multiple parts…[Read more]

The whole team is in charge of launching a product to a target customer. You gotta to have certain a target customer, people who are willing to use the product. The project manager would then put together all the documents required to get the project going. However, marketing is the team in charge of delivering the message to all the “target…[Read more]

The timeline done by the project management would be significantly changed. A poor product would bring down the credibility of the company and it would put in risk the safety of the patients (Additionally, if the project affects the person, demands against the company could arise representing loss of millions of dollars). Whenever a company…[Read more]

The main reason why Design controls are useful is because they test the quality, liability of the product. This would make sure that the clients do no get affected in a bad way by it. On the same way, it would prevent a lot of demands against the company that produced it. For example: Imagine that a patient gets an ulna replacement of titanium,…[Read more]