Post-market surveillance serves an important purpose. Even though medical devices go through rigorous testing pre-market, some adverse events could pass through this phase unnoticed. Post-market surve...

A set record of files and documents that are produced by risk management comprises the risk management file. It should consist of risk evaluation, risk control measures, risk estimation, the risk man...

Implementing risk management is not only ethical but also it provides context on whether a company should purse a project. The risk management process runs throughout the product life cycle starting i...

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 also it also serves as a place of reference when n...

Design controls are a necessary procedure of medical device development. According to the FDA, 44% of voluntary recalls from October 1983 to September 1989 could have been prevented by adequate design...

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 qualities and procedures set forth by the FDA to ensure t...

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 very risky. If some of these medications are succes...

Double blind studies provide an extra veil to protect the integrity of the study. Having both the participants and the medical professionals blind to who is receiving which treatment. This yields any ...

A placebo-controlled trial occurs when one group of study participants receives the active treatment, while the other group of study participants receives a placebo. Everything else is held the same b...

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 and instead just focused on the mission statement an...

A public company issues publicly traded stock, can have unlimited shareholders, is responsible to the SEC, must report financial data quarterly, is subject to Sarbanes-Oxley and PCAOB, can give employ...

Establishing a partnership with a business partner can have many advantages; owners having complete control, keeping all the profits, splitting the profits by ownership percentage, few legal restricti...

A document control system ensures a company is following the proper document management and manufacturing practices required for quality and regulatory compliance. It can also help reduce regulatory r...

Precision and accuracy are very important measurements in science especially when dealing with medical devices and quality control systems. These two measurements have a direct impact on patient healt...

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 wanting to ensure patient safety while advocating ...