I do not work in an industry, however, I currently am taking Capstone which I consider the class to be a Matrix set-up. The reason for this, is I report to both the functional manager i.e.( Dr.Schesser) and the project manager i.e.(Dr. Collins). Capstone is set-up like a matrix management system which I find useful because it allows me to realize…[Read more]

From reading all the response I did some research and found that there are 6 categories involved with Risk Management. They are Risk Identification, Risk Responsibilities, Risk Assessment, Risk Response, Risk Mitigation and Risk Contingency Planning. A Risk Management Plan can be considered a program that is done indefinitely with a company. It…[Read more]

I do not have experience with packaging but have heard from John Crombie the details associated with the packing. Early evaluation of product-packaging compatibility helps to detect design of manufacturing problems. In the worst case scenario that the packing does not meet certain specifications, the early evaluation will help. Basically,…[Read more]

In the purpose section of the QSPT (quality system plan template) the question of “Why?” must be answered. The purpose of this document is to ensure a quality system plan is in compliance with new and revised regulatory requirements. I think its advised to do research on existing products to learn about any new issues that happen to previous com…[Read more]

I agree with as934 and additional to both voices, I want to examine the internal and external stakeholders briefly. We know employees can be considered stakeholders in a company. The first thought I had was laying off employees. Think of the self-checkout services that companies have adopted in past 4-5 years. I assume the project managers of this…[Read more]

This is a timely question to ask! I am in Capstone which is an academic setting however, the fundamentals are what is being taught due to time constraints. One fundamental concept is the customer needs which may be researched by the students and is guided by the academic overseer of the project. Most of the needs come from the overseer due to…[Read more]

This medical device is both a device and drug, therefore it is considered a combination product as stated by regulation. The PMOA is too gather a signal of a patient who took their pill or not and monitors metabolic activity. However, there is a drug component that in turn creates biochemical pathway response. Therefore, a RFD (request for…[Read more]

A few possible solutions if it were ideal situations. First, there should be a regulatory affairs individual from the company that is assisting or consulting with 30%- 50% of the project. This allows for technical input of what regulatory organization should be used for the medical device. Then this individual asks regulatory affairs at the FDA…[Read more]

I say yes it should be regulated by FDA as a Class 1 device at maximum. The reason I state this because when I was taking a class in Medicine and Literature a common theme was commercialization. With commercialization in the medical field, people have information quicker and go to doctors to ask for meds they think will help them because they saw…[Read more]

Dr.Simon has mentioned how for Master students those of which have not taken design classes before unless you have been from NJIT as an undergrad, you know BME 383 (Mantilla) gets you prepared to do your own experiments with the tools you have. With those tools, you must engineer a process with certain parameters to carry out your experiment.…[Read more]