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 ...

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 analy...

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....

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...

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

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 ...

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...

Why do you think Verification is important ? and Your ideas to improve Verification process in a design control ? Verification is an important proce...

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...

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 t...

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 ...

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 i...

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 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...

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 op...