My personal reflection: I understand that this is an MSBT, but I was not exactly sure what to truly expect. The course was very informative for me. I learned a lot of fundamentals that I was not aware...

The type of organization that I work in Matrix Organization (for the Department of Defense for the Army Medical Command). I was working in data analysis for over 10 years in Health Administration in ...

Verbal agreements are oral and are not enforceable by the law nor is it legally binding. Therefore it can be easily dismissed for a number of reasons. A written agreement is documented and therefore ...

Risk benefit analysis is basically a comparison between the risks and the benefits of the situation. It is used to figure out if the course of action to be implemented is worth the risk or if the ris...

A risk management file is a living document that notates risk management activities, documentation, and records for the project. This living document provides evidence of the risk management plan, ris...

Post market surveillance is the requirement that medical devices have to continue to be monitored after they have been cleared for sale and placed on the consumer market for purchase. It is a very im...

DHF can be audit ready if the organization is ensure a set of checks points are conducted prior. In my organization a living document that we have in my department is for provider rounds documentatio...

Why do you think Verification is important ? and Your ideas to improve Verification process in a design control ? Verification is an important process in the development of medical devices because it ...

I consider the customer's input the most important part of the design control. Why? I believe all steps in the design control are some what important but I believe that the customer input is the most...

Yes, someone very close to me suffers adverse events (effects) as a result of medication that they take for TBI. Traumatic Brain Injury (TBI) alters the brains ability to effectively communicate at al...

This topic is near and dear to my heart, Ms. Lacks and her family endeavored and are still processing through the legalities of her cells being taken without her consent while she was alive. The fact ...

In regards to the CRA, monitor, and statistician, from my previous background, it is a plus but not required that individuals what is most important is that they have educational background and knowle...

Piercing the corporate veil is a new concept to me so when I saw this post I was interested and wanted to do a little research. When I think of a veil, I immediately think of the bible and neuroscienc...

I do not have personal experience with owning a family business and how to delegate and pass down the duties and responsibilities of a business, but I would like to weigh in with assumptions. I would...

This is a great question, in the past prior to graduate school this was something that I have gave minimum consideration, literally I would base my opinion on if the name or what I “thought” the compa...