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 in the industry. One might say that the weekly disc...

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 the verbal agreement to be safe. This is because i...

Explain what are the essential factors when creating a confidential agreement. Also, explain the steps you would take if the contract was not maintained in secrecy. How would you resolve the issue?

I believe working with someone more knowledgeable in the specific role is better because experience is everything when just getting started. For example, most jobs are looking for people with at least...

The design development plan should include the budget, a product design schedule, and tasks that must be completed. Without these three main components in the design development plan, one can have sev...

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 make an important decision, you would go to others f...

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 with their work, it would be great for the projec...

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 device is doing on the market and see the feedback...

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 real world, especially if it is a life-dependable...

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 standards. Some ways you can minimize low-quality p...

The Design Specification Document (DSD) gives the numerical details of the product and explains every individual piece with the size and tolerance. The DSD can contain all the drawings and blueprints ...

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 completed correctly is to create tests for the prod...

Posted by: @kbentleymsm-edu Consider the Design Controls lecture that Dr. Simon has made available. Yes, we know that all parts work together to support the goal of medical device development. What...

If you were making a product, how would you make sure the product is always high quality and fully functional? What are some ways you can minimize low-quality products? Also, when should design contro...

Explain the similarities and differences between design verification and design validation. Also, which is more important than the other, and when are they used in the design control process?