So far, I've taken two of Dr. Simon's courses, and I enjoyed them because they allowed me to get a glimpse of the real world and see how things work i...

If only two people are present while making the verbal agreement, then it will not be sufficient. Three other people should be present while creating ...

I believe working with someone more knowledgeable in the specific role is better because experience is everything when just getting started. For examp...

The design development plan should include the budget, a product design schedule, and tasks that must be completed. Without these three main component...

In a functional organization, if the decision is made only by one person, then something has gone wrong somewhere. This is because usually when you ma...

This can affect both teams positively or negatively, but there are different scenarios. For example, if the risk management team is having a hard time...

Post-market surveillance is needed for all medical devices after they are on the market. So post market is essential because it will tell you how the ...

This is a great question; it should never be okay to accept the risk of something that may affect someone's life. However, there is always risk in the...

To ensure a product is always high quality, one should make checkpoints between the manufacturing stages of the device to see if everything is up to s...

The Design Specification Document (DSD) gives the numerical details of the product and explains every individual piece with the size and tolerance. Th...

Design verification is in the check phase, so this is where one makes sure the outputs equal the inputs. One way to ensure the verification phase is c...

I believe the design history file (DHF) of the nine design controls is the most important because it contains all the documents for the whole project....