While a patent is a federal document providing ownership of an idea, NDA which is non disclosure agreement is just a simply contract between two peopl...

I think I am very lucky to take this course before I graduate. I always hope that I can learn some information about medical device company before fin...

Generally speaking, most contacts can be either written or oral and legally enforceable, however there are several types of agreements which have to b...

If I were to start up a medical device company, I will choose matrix type organization. One of the reasons is that because the matrix structure is mor...

I would like to work in matrix type organization. As mentioned in the video, the matrix organization structure is a combination of two or more types o...

I found a few tips for avoiding dysfunction of team project on the internet. 1. Size, Go with smaller teams—the bare minimum necessary to get the work...

I do not have experience. But I searched about it online and found that for risk identification, the project team should review the program scope, cos...

I found that the ALARP concept contains legal interpretation of the regulatory process that promotes financial consideration in higher regard than of ...

The differences between medical device and pharmaceuticals are, firstly, Medical devices are based on biomedical engineering and, as a general rule, e...

I will mainly talk about customer input sources. Every organization actually has two different types of customers: Internal Customers and External Cus...

I have less experience on writing protocols but I searched about this online and found that sample sizes are calculated based on the magnitude of effe...

I searched about the Korean Regulatory System The Ministry of Health and Welfare (MHW) is the primary healthcare agency regulating the importation of ...

Regardless of the device classification, Design Controls are a critical component to medical device product development. Design Controls demonstrate y...

In my opinion, the most important phase is scope management plan. scope management plan is the collection of processes used to ensure that the project...

I think insufficient design control would, firstly, waste money and energy, since engineers spent time and money on useless design. It is also kind of...