Hey Roberto, I believe that those guidelines are a bit too restrictive, however they do serve a purpose. Basically, these guidelines are set in place...
Maybe "Medical Device Production" or something along those lines, perhaps to make it clearer this is more about the business aspect of putting a medic...
Dr. Simon, As some others have said, when I first enrolled in the course, I thought I was going to learn about the theory of developing medical devic...
I agree with pretty much everything you said. I believe organizational structure can have an affect on the culture, but I think it's mainly there to d...
I agree that choosing your team isn't always an option and it's better to find people who are good at what they do. For this reason, I don't think it'...
As others have said, the best organizational structure depends on the size of the company. Still, though, I think in most cases, the matrix organizati...
I agree with what you've written above and I think the problem lies within the company's philosophy itself. More often than not, these companies are n...
Although I don't have any direct experience with Risk Management, I would assume that people in risk management must be able to consider all possibili...
Hey Dhairya, Maybe I'm mistaken but I don't think we can properly say which tactic we'd use for low severity or high severity without also noting the...
The bullet points you listed as well as what others have said cover a lot of what is required of a Gantt chart. However, I'd like to emphasize what sh...
I also agree that it is in a small company's best interest to utilize outsourced manufacturing. This is mainly because, for a growing company that doe...
As some have said, I think the biggest issue for design transfer would be communication between the design team and manufacturing teams. There should...
I completely agree with you! All components of the DDP are very important, however if I had to choose one, it would most likely be the quality managem...
Hey Lamiaa, I guess the most obvious consequence of insufficient design controls is wasting time. Designing a medical device is no easy task and ther...
Design Controls to me are basically risk management and safety checks for a company. These allow a company to run through a list of checkpoints before...