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 and allows for greater collaboration amongst different departments. Information…   Read more»

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 level of risk. Then a risk estimation must be…   Read more»

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 needs are met, the product functions…   Read more»

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 be overlooked, leading to a potentially defective…   Read more»

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 declaration of conformity, the design dossier, and…   Read more»

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 are dealing with patients from drawing…   Read more»

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 flexible management structure and can be…   Read more»

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 interpersonal relationships. Emotional intelligence is considered an interpersonal skill that is…   Read more»

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 mastered grabbing attention via comedic videos. Many companies use…   Read more»

Once the physician has an idea, they must determine which class their device falls into. The next concern would be the presentation of the idea to the FDA. They would need to submit an Investigational device exemption if the device…   Read more»

Quality assurance is all of the processes established to ensure that a company is producing the best product to their customers. This process protects the safety of consumers that use the product. Quality control is the action of inspecting products…   Read more»

I believe it is important to protect your investments. It takes time and money to build a company. When dealing with medical devices, it can be an even longer process, due to the scientific process behind many of these devices….   Read more»

I am referring to the material having the desired interface with the tissue. Breast tissue is soft and fluid. A biomaterial acting  as an implant must be fluid in nature as well, to match the interface of the breast tissue. 

In order to test this new bio-material, I would perform testing based on the ISO 10993 international standard. This standard has 18 parts that evaluate how a device will be used and which tests to perform. It includes how the…   Read more»