The difference between quality control vs. quality assurance is the activities involved. Quality assurance focuses on providing the confidence that yo...

The accuracy of the device qualifies how it performs in comparison to existing values. With precision, the FDA evaluates if the device is functioning ...

An example of a combination product is antibiotic-impregnatedbone cement (also referred to as antibiotic-loaded bone cement)releases the antibiotic ag...

Animal testing is an unfortunate reality for product assessments. The pain and suffering animals endure comes attached to the advancements and researc...

In academia, the research is done out of passion and interest and less focus is paid to monetary benefits. On the other hand, in industry, it's all ab...

It is not rational for researchers to test new treatments in humans before they have been tested and researched in lab animals. How disease works, and...

I agree with the previous discussion that many medical devices tend to have a risk, even if they are approved. And almost all of the drugs have some o...

Medical Device Risk Management is a systematic approach of identifying, analyzing, evaluating, controlling, and monitoring all kinds of risk for a med...

The theory offers a basis for organizational development with high employee motivation to achieve company objectives. An organization that satisfies M...

In my opinion, one of the defining characteristics of a matrix organizational structure is that it: overlays two organizational structures in order to...

Hi from last week's lecture about organizational development, we learned about three types of medical device organization. I would say, for the initia...

Validation can be defined as the process of evaluating a product to determine if the device satisfies the user requirements. In other words, Validatio...

A design review meeting is done at the end of each phase. A design review meeting is a discussion that occurs among cross-functional teams to evaluate...

Design verification is essential to eliminate the potential failure of a product even in the early stage of the product development phase. With verifi...