Last seen: Oct 13, 2021
Post-market surveillance serves an important purpose. Even though medical devices go through rigorous testing pre-market, some adverse events could pa...
A set record of files and documents that are produced by risk management comprises the risk management file. It should consist of risk evaluation, ri...
Implementing risk management is not only ethical but also it provides context on whether a company should purse a project. The risk management process...
Meeting minutes serve as an official record of the proceedings that took place. Not only does it keep people in the loop that missed the meeting, but ...
Design controls are a necessary procedure of medical device development. According to the FDA, 44% of voluntary recalls from October 1983 to September...
Proper design controls are needed due to the most frequent causes of recalls being from issues related to design. Design controls are a set of qualiti...
The Right to Try Act gives hope to individuals who have terminally ill diseases. Trying these medications that are in early phases of development is v...
Double blind studies provide an extra veil to protect the integrity of the study. Having both the participants and the medical professionals blind to ...
A placebo-controlled trial occurs when one group of study participants receives the active treatment, while the other group of study participants rece...
I think looking into a company's corporate structure before accepting the job is a good idea. Before this course, I would not have thought to do so an...
A public company issues publicly traded stock, can have unlimited shareholders, is responsible to the SEC, must report financial data quarterly, is su...
Establishing a partnership with a business partner can have many advantages; owners having complete control, keeping all the profits, splitting the pr...
A document control system ensures a company is following the proper document management and manufacturing practices required for quality and regulator...
Precision and accuracy are very important measurements in science especially when dealing with medical devices and quality control systems. These two ...
This is a really great question. I do not think that the FDA's rules and regulations are too strict. Even though their mission statement is two prong ...