To clarify from my original post, I would think as per the conditions listed by the FDA for what devices qualify as a Class 2 device and what prohibits devices from filing a 510(k) as per the post fro...

Thank you @wonbum-sohn for creating this post and for everyone who has responded. As mentioned in other threads, I am working on a point of care device for early cancer screening. Although the targete...

I have never worked in regulatory affairs, however, my understanding is that it is an essential segment of every industry, let alone the medical device industry. An individual working in regulatory af...

It is interesting how everyone has reflected back on their days in senior capstone, which is a perfect example of a project - a temporary endeavor to create a unique product/service that drives change...

To answer this question, let's first define a program. A program is a group of related projects that are managed by a team as opposed to an individual. Therefore, as per chapter 1, section 2.3.2 in th...

Hello everyone! I know for week 1 we were only asked to read through chapter 1 of the PMBOK Guide and information on organizational structures is in chapter 2, section 4.4 but I still wanted to respon...