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 people. NDA can provide people with a level of protecti...

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 finding job since Lack of knowledge in the industry ...

Generally speaking, most contacts can be either written or oral and legally enforceable, however there are several types of agreements which have to be in writing. I listed them below. 1. Real estate ...

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 more dynamic because it allows employees to communica...

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 of organizational structures, such as the projectiz...

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 done. The typical project team size is five to ni...

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, cost estimates, schedule (to include evaluation of th...

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

The differences between medical device and pharmaceuticals are, firstly, Medical devices are based on biomedical engineering and, as a general rule, either permanently or temporarily replace a body fu...

I will mainly talk about customer input sources. Every organization actually has two different types of customers: Internal Customers and External Customers.Most people are familiar with their externa...

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 effect that the researcher would like to see in his tr...

I searched about the Korean Regulatory System The Ministry of Health and Welfare (MHW) is the primary healthcare agency regulating the importation of medical devices. Under Korea’s Medical Devices Act...

Regardless of the device classification, Design Controls are a critical component to medical device product development. Design Controls demonstrate you have designed and developed a medical device th...

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 includes all the tasks required to complete the p...

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 financial loss for the company. Moreover. It is a...