Hi Fady, I agree that it is not clear as to what exactly "as far as possible" means and what standard it is being compared to. This statement definitely implies that all risks cannot be reduced comple...

Hi Abhishek, After doing some research, I found that conducting a hypothesis test of effects/relationships (power analysis) would be ideal in determining sample size. Studies that attempt to determine...

Hello, I have yet to gain industry experience, but I do have experience in creating Gantt charts for my Capstone class. A good practice is to start off by documenting what the purpose of the Gantt cha...

The responses on this post do a great job at illustrating why meeting minutes are important. Meeting minutes are there to represent what initiatives a company takes and serves as legal protection. The...

Like Hetal mentioned above, it is a good idea to conduct a human factor study even if no changes were required after verification. For medical devices, it is crucial to run the human factors/usability...

While watching this week's lecture on design control, I tried to figure out the main difference between Design Verification and Design Validation. Both are used to make sure that the design outputs al...

Hi Lamiaa, thanks for bringing this topic up. From what others have mentioned, it can be seen that the problems that arise from insufficient design control are significant. I wanted to give a couple o...

You make an interesting point Lamiaa. It definitely becomes a problem when a company strays away from adhering to their design controls. I am not quite sure what you mean when you say that "when the p...