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 surveillance allows for the monitoring of medical devices after they have hit the market. There…   Read more»

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 management plan, and the criteria for risk acceptability among…   Read more»

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 in pre-market where experimentation begins, running throughout the product…   Read more»

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 needed. On would…   Read more»

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 controls and the most frequent causes for recalls are…   Read more»

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 the medical device meets user…   Read more»

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 successful, I think this is a great…   Read more»

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 unintentional biases that the medical professionals could unknowingly…   Read more»

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 between the two groups, so that any difference in their…   Read more»

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 and the company’s vision.  However,…   Read more»

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 employees stock options among other rewards. Some examples of a public…   Read more»

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 restrictions and, uncomplicated taxes are a few. However, there are many disadvantages when…   Read more»

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 risk. To improve a document control system is by introducing automation to…   Read more»

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 health. The FDA requires that medical devices should be precise producing the…   Read more»

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 for innovation, the rules and regulations…   Read more»

Animal research is essential to understanding the pathology and treatment of diseases. I can understand why some animal activist groups deem animal research to be flawed and unethical, but there is not another model that can mimic human disease as…   Read more»

The academic sector is research and discovery focused with many of the projects focused on expanding the current knowledge scope of the field. While industry relies on creating products that can have an immediate impact on lives while making a…   Read more»

In academia, research is pursued based on passion leading to a thrill of discovery. Thought leaders in this field have success paths that follow the ways of earning a Nobel Prize, becoming Head of the Department, fame, notoriety, being an…   Read more»

When pursuing new roles, I prefer to be under qualified for the position, this would allow for growth by learning new ideologies and concepts on the job while also providing a challenge. Being overqualified for a position does not provide…   Read more»

Even though medical devices are used across a variety of fields, I do not think it would be beneficial for individuals to pursue a medical device certificate if they do not intend to work in the field. Although gaining knowledge…   Read more»