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 hav...

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 cu...

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 p...

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 se...

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 o...

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...

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 b...

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 ...

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 g...

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 ...

Ethically speaking, one cannot skip over any regulations, regardless of what the situation might be, monetarily. The main aspect of the situation must...

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 actua...

According to the FDA, the medical devices are characterized into three categories based on a few factors. According to them, "The FDA categorizes medi...