In this simulation, there were a few paths you could take to complete the mini simulation. The first one I took, which seemed the simplest, was to have Patty and Dr. M sit together and figure out the ...

Design Verification entails that the product you put out is what was actually requested and what the FDA has said is acceptable. Let's say that the customer wants a product that addresses issues A, B,...

Scope creep mainly occurs when the interference comes from upper management. They see that a product is capable of A and B and then they ask if C is possible and push for it. I think that a better way...

Although I have no medical device industry experience, I have worked on team projects in other fields. As a supervising teacher, I have had lead on several projects that have been implemented with var...

Following up on what bnb6 said, I think that we should also discuss metal-on-metal (MoM) hip replacements and the special risks they carry. In terms of risk management, they are far less likely to be ...

Hey, I also think that information that is discovered once the verification is over should also be discussed. This could lead to additional or updated reports that would be necessary, especially if di...

We've previously discussed what risk management. The concept is to ensure that all risks are minimized and only those that are necessary for the project are taken. The point is to be as cost effective...

Going back to Devarshi's original point, I think it is actually good that sometimes a user's needs are a bit vague. This allows the engineer to be a bit more creative catering to the needs of the user...

The Gantt Chart is actually really great for any sort of project management but especially helpful for the medical device field because it allows for projects to be seen visually by all members of the...

Everything is about risk -- as everyone above me has stated, its all about whether the good will outweigh what might possibly go wrong. Therefore, a good PM must be able to analyse and handle the risk...

According to the PMBOK, standard process groups can be created and applied (and edited as needed) for companies. Most companies have a dynamic way of doing their projects and if they are able to pin d...

Ethically speaking, one cannot skip over any regulations, regardless of what the situation might be, monetarily. The main aspect of the situation must be that the device follows all regulations and pr...

So far this semester, we have gone over the requirements of testing and have seen the side of quality testing from the POV of the medical device companies. However, we are aware that issues have come ...

What I find to be actually pretty interesting now is that we're in the age of Kickstarter. Scientists and engineer who have innovative ideas are actually able to bypass much of the needed fundraising ...

According to the FDA, the medical devices are characterized into three categories based on a few factors. According to them, "The FDA categorizes medical devices into one of three classes – Class I, I...