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 is an intra-aortic balloon which is a class two d...

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 quality department is particular about matching cert...

Name a combination product which is currently on the market such as a drug releasing stent. Specify the primary mode of action and department you believe that the device should be under(CDER, CBER, C...

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 released after the writer’s wife used the Karl Storz...

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 to the regulatory structure that we identify with ...

Based on this week’s lecture there are numerous differences on how research is approached in an academia compared to industry. Name two ways that research is approached in academia versus industry. Ou...

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 completing an animal test on a specific animal then y...

Prior to clinical trials biocompatibility testing should be completed in regards to ISO 10993. The types of biocompatible tests needed for a particular device can be determined by using the toxicity t...

Give an example of a time when you encountered an obstacle while working on a project that could have resulted in not reaching the deadline. What phase of the project life cycle should you have focuse...

Project manager for a medical device company differs from that of a building/skyscraper due to FDA regulations. Project managers of medical device company have to follow design controls and regulation...

This week’s lecture discusses the different phases within a project life cycle; initiating, planning, executing, monitoring & controlling and closing phase. Which phase of the project life cycle d...

For those who have work experience in the medical device industry, what advice would you give to Biomedical Engineering students? What would you have wished you would have done differently as a studen...

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 career forward based on your work, industry is more p...

The current academic to practical course ratio provided by NJIT is not beneficial to students entering the workforce. From personal experience, I found it shocking that my bachelor’s degree did not re...

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 Manufacturing Engineer because they received a six sig...