I would prefer to work for a matrix style organization. Each organizational structure has its downsides; however, I believe the matrix style organizat...

The ISO regulation that governs risk management is ISO 14971. A medical device company is required to perform a risk assessment. This includes perform...

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. ...

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 o...

Although a DHF is not required in the EU, design controls are still necessary. There are documents that are necessary when designing medical devices i...

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...

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 par...

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 ...

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 tim...