I would prefer to work for a matrix style organization. Each organizational structure has its downsides; however, I believe the matrix style organization structure allows for the best use of resources...

Trade secrets are typically for items that cannot be patented. In the case of the Coca-Cola example, the recipe cannot be patented because it is created using ingredients that are not novel in nature....

Upper management is strategic and middle management is tactical, according to the lecture. What exact traits would be required for each level of management? Upper management is responsible for the ope...

A risk management file is the culmination of all documents related to the risk management process. It is a living document, and includes a risk management plan, risk analysis, risk evaluation, risk co...

Risk control is the process of identifying a risk and implementing changes that reduce the risk in order to protect the user of the product. The three types of risk management are product design, prot...

The ISO regulation that governs risk management is ISO 14971. A medical device company is required to perform a risk assessment. This includes performing risk analysis to identify hazards and their le...

Design controls are a set of quality practices and procedures required by the FDA during the design process. They are established per 21 CFR 820.30. These processes are in place to make sure user nee...

One issue that can arise from the design control process is the improper assessment of the risks associated with the product. If the potential risks of a product are underestimated, certain tests may ...

Although a DHF is not required in the EU, design controls are still necessary. There are documents that are necessary when designing medical devices in the EU. These include the technical file, the de...

What is a multi center clinical trials and what are some difficulties faced with this trial design? What can be done to reduce these issues? A multi center clinical trial is a single clinical trial ca...

When performing clinical trials you will often see the design of these trials will be randomized and blind. But what do these terms mean? A randomized trial refers to how the control or the test medic...

I believe that it is important to have a clinical background when working on clinical research, Although this does depend on the capacity in which you are working with patients. This is because you ar...

An LLC is a business structure that offers limited liability protection. It has a flow-through taxation process. LLC’s can choose to be taxed as a partnership or as a corporation. An LLC has a flexibl...

Emotional intelligence refers to the ability to be aware of, understand, and communicate one’s own emotions, as well as the ability to empathize with others and communicate effectively in interpersona...

With the plethora of social media platforms and short attention spans, it has become an art to grab attention before the viewer scrolls down their timeline. Many social media "influencers" have master...