Advantages of written agreement: The main advantage to the drawing up of contracts to minimize liabilities is that it reduces the risk that the company issuing the contracts will be sued. By making su...

There are several disadvantages of verbal contract. The most common argument against a verbal contract is the lack of solid evidence. Since we are dealing with medical device, we have to keep in mind ...

Dr. Simon, There are two things that I really liked about this course. One is that it gives a good understanding of each department in medical device industries. So, this way student taking this cours...

It will be very difficult for project manager to work in matrix organization. There are several problems that can arise. There is three main difficulties that project managers might face: secrecy and ...

Picking a project team is very crucial for a successful project execution and completion. You have to pick the right people for the job. It doesn’t always mean you have to get the most experienced peo...

I would like to work in matrix organizational structure because it brings together employees and managers from different departments to work toward accomplishing a goal. There are advantages of implem...

I certainly agree with everyone that acceptance would not reduce any risk out of these four. Accepting the risk means that once you have identified it, you take no action. You simply accept that it mi...

I have had the opportunity to work on risk analysis at the company that I worked for in past. The risks were given numerical values based on three categories and the total risk was the product of thes...

Creating a list of risk is a good starting point, however, it is not enough on itself. You also need an action plan for each risk in order to be able to manage them effectively. We learned about the s...

Source of design input is the market research of the product. What it is that is needed. From this you can figure the customer needs. Once the customer needs are set, it is easier to plan design input...

It is very important to know the difference between verification and validation plan while working in medical device company. It was also not clear to me in the beginning but once after working on a p...