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...
Although I agree with @Adrian and many others about the matrix organization, I actually work in a small collaborating environment that use the project...
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 ...
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 man...
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 proce...
I would like elaborate @merzkrashed's point about the FDA article "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Prema...
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 t...
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...
HI, @Scott, I haven't done any protocols for medical devices but in the past working in clinical settings, we have planned different protocols, propos...
I agree with @gaberuiz13 that the tests have to make sense. Specifically, some products already have a set of "gold-standard" validation protocols to ...
@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 a...
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. ...
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 (be...
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. ...
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 lect...