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 of, I…   Read more»

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 different sectors moving around for the…   Read more»

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 is evidence-based. It can be followed…   Read more»

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 risk is too…   Read more»

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, risk analysis, and risk evaluation. All three areas are important to…   Read more»

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 important factor because it demonstrates the…   Read more»

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 documentation for inpatient consults or rounds…   Read more»

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 is the “check phase” as Dr. Simon…   Read more»

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 important because a product…   Read more»

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 all times.  There are a few treatments available…   Read more»

 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 that her cells are…   Read more»

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 knowledge in sciences and some health care administration/…   Read more»

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 neuroscience. …   Read more»

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 assume that the parents…   Read more»

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 company stood for, was…   Read more»

I have several examples of Quality department issues with work experience over the years. To be specific, I will talk about our quality department where I currently work. Unfortunately, depending on the organization, people are able to get away with…   Read more»

If I am QA auditor, there are two things that I am going to focus on: identifying the deficiencies of the regulatory framework of the project and to identify employees who are non-compliant. It should be understood that FDA standards…   Read more»

Working in a military hospital that services civilians in the city in which we are located I have seen poor quality of service due to incorrectly written consults for additional services and treatments for patients.  We have a quality assurance…   Read more»

As research scientist I venture to say I want both, I want my work to be beneficial for today’s access and I want my work to inspire and lead to discoveries or pathways to new aspirations at the same time….   Read more»

Yes, all living things have rights, so do animals; there is never a just cause to be cruel. In the same aspect, I believe animal testing is a crucial step that is needed to protect humans. As we discuss making…   Read more»