Thank you for teaching this course. What I love most about it was the information-rich lessons and flexibility. The lessons were organized in separate topics and videos for each week so they are very ...

Although I agree with @Adrian and many others about the matrix organization, I actually work in a small collaborating environment that use the project-based organization well. We were managed by a man...

I personally perfer upper management because I tend to look at things in a big picture and for long term processes and I agree with @dag56 and @scott that to be a upper manager, you should have to hav...

I was in a Matrix Organization where I had 2 direct bosses. The organization was not as clear as in the lecture that each project has a functional manager and a project manager. We typically work in v...

I agree with other about the ISO 14971 and Yiming Chen about the key terms. I would like to elaborate on the major phases of the risk management process aligning with ISO 14971 standard (Adding on to ...

I would like elaborate @merzkrashed's point about the FDA article "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications". When d...

I agree with Mark about the formality, necessity, and process of a risk and with @dag56 about profit/risk scale. I think it would also be beneficial to have prior smaller meeting building up to this b...

In my opinion, I don't agree with the previous comment If I understand correctly about numerous trials. Instead, a company/manufacturer should have an established procedures with a defined operating c...

HI, @Scott, I haven't done any protocols for medical devices but in the past working in clinical settings, we have planned different protocols, proposals. We mostly used Gpower analysis to determine t...

I agree with @gaberuiz13 that the tests have to make sense. Specifically, some products already have a set of "gold-standard" validation protocols to follow, such as blood pressure cuff. There are myr...

@ppp23: if you are asking about what it is, it stated on that document that "Design output means the results of a design effort at each design phase and at the end of the total design effort. The fini...

I agree with previous comments about the need of HF. I came across this interesting situation where it seems like validation could be a bit flexible. There's this article from Arena Solutions giving a...

To add in @ao242 comment about ASEAN Medical Device Regulations, Vietnam is one of the countries that import a lot of medical devices. In the past (before the end of 2016), there were 2 distinct bodie...

It's important to have clinical trials. I agree with Mark and @reshamn on this point. I also want to point out that before going on clinical trials. The drug and medical devices being tested must have...

I agree with @srg36 that placebos are very important. The expectation is a very powerful thing. Similar to the example Dr. Simon mentioned in the lecture, sometimes, when people call to make an appoin...