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 so that a physician who is being pitched a product...

Maybe "Medical Device Production" or something along those lines, perhaps to make it clearer this is more about the business aspect of putting a medical device on the market versus the actual engineer...

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 devices and the technological knowledge that is required...

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 define the goals of the employee. Depending on the ...

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's necessary to have someone you already have a goo...

As others have said, the best organizational structure depends on the size of the company. Still, though, I think in most cases, the matrix organization would be best for most companies. This allows f...

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 not making devices to "help people" but rather to m...

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 possibilities and look very far ahead in terms of the outco...

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 frequency of those risks. That being said, I think...

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 should be on a Gantt chart. Because it is a plan cre...

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 does not have the resources yet, they cannot afford t...

As some have said, I think the biggest issue for design transfer would be communication between the design team and manufacturing teams. There should be a lot of oversight between the two to ensure t...

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 management plan. Quality management and control act as ch...

Hey Lamiaa, I guess the most obvious consequence of insufficient design controls is wasting time. Designing a medical device is no easy task and therefore requires many moving parts and complex proces...

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 their product is put out on the market to ensure ...