I worked on several projects for R&D which always got delayed due to disagreements with the quality department. One major product that we produce...

Coming from an engineer working in the medical device industry, the quality department is crucial in the success of our products. Yes, at times the qu...

I found another article that specifies the issues with the FDA’s center of medical device and radiological health. The main reason this article was re...

According to the FDA update from November 2014, the de novo is a sorting process that categorizes novel devices based on risk strategy. It is similar ...

With any type of animal testing the main pitfall stems from delays. The process of ordering animals is time consuming and also limited. If you are com...

Prior to clinical trials biocompatibility testing should be completed in regards to ISO 10993. The types of biocompatible tests needed for a particula...

Project manager for a medical device company differs from that of a building/skyscraper due to FDA regulations. Project managers of medical device com...

Coming from an individual who has work experience in academia and industry there are pros and cons for both career paths. In terms of moving your car...

The current academic to practical course ratio provided by NJIT is not beneficial to students entering the workforce. From personal experience, I foun...

I do not have a six sigma belt certificate but I have heard about it from employees and friends. A friend of mine was able to get a job as a Lean Manu...