Why compliance fda medical device quality system regulation

Reference no: EM133695475

Assignment:

You are the Director of Regulatory Affairs for Super Cool Medical Devices, LLC, where your company has been manufacturing and distributing drug eluted aortic stents for seven years. The company has been in existence for ten years, it has a total of two hundred employees and the devices are manufactured, packaged and sterilized on-site.

Earlier this week, upon arriving to work, you and your colleagues were informed that the President and CEO, Jimmy Krackercorn, unexpectedly passed away and his son, JJ, will be immediately assuming the role as President and CEO.

To give confidence to the workforce, JJ's biography was shared as follows: JJ recently graduated high school and has extensive experience in the pizza delivery business. He currently holds the world record for number of pizzas made in 10 minutes and another world record for the most pizzas delivered in 30 minutes. Though JJ has no formal education, training or experience in the medical device industry, he brings with him years of stories his father shared about the company and can 'put the puzzle together'.

Two days following this big announcement, JJ calls you into his office. Upon introducing himself, he shares that he keeps hearing about some "FDA quality system regulation thing" and he wants to 'fine tune it' the way he did in the pizza business. He goes on to tell you that in the pizza business he was known as the king of efficiency and he knew how to get his customers pizza, and fast. He further states that he is committed to expediting the manufacturing process by removing many of the "unnecessary" obstacles that he noted during his tour of the facility. Finally, he informs you that he never had to deal with inspections in the pizza business and he doesn't feel that anyone has the right to come in and inspect his facility without his approval.

As you sit there amazed at what you are hearing, JJ gets out of his seat and stares out the window for several minutes while sharing that making a drug eluted aortic stent can't be any harder than the pizza concoctions he made in his previous employment.

Page 1 of 2

Medical Device Regulation

Spring 2024

Assignment

JJ asks you to describe in writing why compliance to the "FDA medical device quality system regulation thing" is so important.

Additionally, he wants you to explain what the QSIT based inspection is and what might happen if he removes too many of the in-house requirements, processes and procedures as he simplifies things to make them more efficient like the pizza business.

Reference no: EM133695475

Questions Cloud

Clinical course of pulmonary hypertension : What is the sequence of events that occur during the clinical course of pulmonary hypertension?

How can mitigate disparity of health and long term supports : How can we mitigate the disparity of health and long term supports and service (LTSS) delivery systems for people of color?

About whether george should get vasectomy : Describe the three main components of evidence-based practice that should be used to make the decision about whether George should get a vasectomy

Reality orientation techniques to validate clients feelings : Explain how you can use reality orientation techniques to validate your client's feelings

Why compliance fda medical device quality system regulation : JJ asks you to describe in writing why compliance to the "FDA medical device quality system regulation thing" is so important.

Utilizing eriksons stages of development : Utilizing Erikson's stages of development, identify 3 considerations with rationale when caring for Lucy, a 3 year-old hospitalized patient.

Medication management : The patient is a 45-year-old white female who presents for follow-up medication management.

What is the present value of the cost of the surgery : What is the present value of the cost of the surgery and follow-up treatment? What is the ICER between the surgery and no surgery options?

Change agent during your time as nursing student : Provide an example of someone that you have seen acting as a change agent during your time as a nursing student.

User Account

All Pages