I think Project Management is very important in Medical Devices field. I am wondering in medical devices field, if the companies are likely to create the department within their companies for project management, or are likely to contract with a…   Read more»

Through the class, I was well aware that project team sets early start day, early finish day, late start day, and late finish day when scheduling tasks. By what criteria are early start days and late finish days determined?

I heard that the members of project team can be included in a risk management team. What are the pros and cons of separating the risk management team from the project management team? What are the pros and cons of…   Read more»

In the medical devices field, should procedures or standards for verification and validation tests be approved by the FDA?

During verification test to check the specification, input and output from DSD, what is the probability of having to change the budget for additional experiments? Also, how well are the budget change proposals accepted?

If entering the project management or regulatory department of a company that makes and sells medical devices, what does employees usually do to maintain the licenses for manufactures from the FDA? Is the maintenance procedure very complicated?

In medical device management, which type of functional organization, project-based organization, or matrix organization is most common?

It seems that risk analysis and risk management are important, but that they are a very difficult part for those who lack experience. If I work in the project management field, will I receive training in risk analysis or rick…   Read more»

I’ve heard about verification and validation through lectures, but I’m still not sure about the difference between the verification and validation. What exactly is the difference between verification and validation?