@zbw2 Certain regulations are in place to standardize practices among all medical device companies, not necessarily because these regulations will impact the effectivity of the product. For example, there are strict compendia regulations for how to test certain medical devices…   Read more»

@Zbw2 brought up an intriguing argument regarding market competition encouraging quality. A firm will be concerned with quality if they want to ensure that their product is better than all of its rivals. While I believe this to be true,…   Read more»

@zbw2 spoke on a good system to use when considering risks. They mention that during the brainstorming part of the process, priority should be put on risks associated with the most critical parts of the device that can’t be avoided,…   Read more»

Posted by: @zbw2 China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA “revised [their]…   Read more»

Posted by: @zbw2 China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA “revised [their]…   Read more»

@Zbw2 made an interesting point about market competition as a motivating factor for quality. A company wants to make sure their product is better than all the competitors, so they will be concerned with quality. While I think this is…   Read more»