Dr. Simon, I appreciate the material that you are teaching in this class as it is extremely applicable to the industry. This course has allowed be to expand my knowledge in my current position and has...

False Claims Act violations can result in the following: • Damages penalty triples the amount of money defrauded from the government • Claim penalties from $11,000 - $22,000 for each claim that violat...

Currently, I work in a Matrix Organization which is project-based, where there is a representative per functional group that is responsible for successfully moving the project through the developmenta...

I am surprised to hear as well that instructions for use (IFU) and labels are deemed as the least effective way to solve residual risk since the amount of effort that is taken to ensure the content on...

As hc225 mentioned, from experience in the industry, AQL levels are in place for the critical dimensions from the technical drawings of the product. Quality Control (QC) measures are conducted for eve...

Hello, I have recently participated in a Medical Device Single Audit Program (MDSAP) audit and am currently preparing for the second part of the same audit within the end of this year. MDSAP is a sing...

Hello, General consequences of insufficient design controls: • Design not meeting the needs or wants of the intended market/customer • Faulty product in the market requiring replacements • Product hav...

Hello, I have some experience developing Gantt charts through my undergraduate program and through industrial experience. From my perspective, some important factors before starting the Gantt chart ar...

As a Project Coordinator who takes the meeting minutes from each meeting, I agree with Dr. Simon’s push on the importance of taking meeting minutes. Meeting minutes captures the discussions of the mee...

Through my experience working as a Project Coordinator in the medical industry, I have encountered a two verification tests that didn’t meet the design requirements that were in place for that product...

Guidance for Clinical Trial Sponsors: I would select to be a sponsor for clinical research because they are responsible for initiating the clinical investigation, documenting the research, and submit...

Marketing research indicates that approximately 80% of visual information is based on color and a person can only keep 3-4 pieces of information stored in short term memory at one time. A lot of time,...

From experience in the industry, the company’s Marketing lead for that project will reach out to their sales team in each region or country and have initial discussions to understand the markets needs...

Marketing is having the ability to understand the customer’s needs and wants and utilizing those specific tenders into design inputs and marketing outputs. Sales is understanding the design outputs an...

Private companies, in my opinion, have more of a small business feel even though they can be very large in size. They have a small number of owners, they are not traded publicly, yet the shares are am...