I really like this course, it gives you good industrial insights on a structural manner. I think this course help me to Identify the suitable job profile, now I clearly know I am not a academia person and I am definitely going to the industry after I graduate. In my opinion this course teaches you how to apply the things you have learned in other…[Read more]

NDA is a contract, and contract law is an entirely separate field from patent law. How contracts are interpreted is a matter of state law, and interpretations vary from state to state. Our firm practices patent law, which is federal, and so is interpreted uniformly throughout the United States. Another thing NDA gives you a limited level of…[Read more]

I don’t think this is to restricted, it should be this way. I will say companies should not even pay $100 because even doctor is also is making enough money by doing the surgery and if the the doctors want best for their patient they have to use the best product out their in the market. My parents are nurses in India and I know a lot of doctors…[Read more]

I would like to work in Process-based organizational structures, because it is designed around the end-to-end flow of different processes, such as Research & Development, Customer Acquisition, and Order Fulfillment. Unlike a strictly functional structure, a process-based structure considers not only the activities employees perform, but also how…[Read more]

In my opinion the best and most effective organizational structure is Circular Organizational structure the circular structure still relies on hierarchy, with higher-level employees occupying the inner rings of the circle and lower-level employees occupying the outer rings.What I mean by that is the leaders or executives in a circular organization…[Read more]

I would say I want people in my team who have more knowledge in their department, because we are working on a project and we want what is best for the project. Sometimes working with people we have better relationship makes it harder because if they lack at some point it might hut out relationship but also it will affect the project, I will it…[Read more]

ISO 31000:2009 provides principles and generic guidelines on risk management. ISO 31000:2009 can be applied throughout the life of an organization, and to a wide range of activities, including strategies and decisions, operations, processes, functions, projects, products, services and assets. ISO 31000:2009 provides generic guidelines, it is not…[Read more]

From low severity and for high severity of risk:-
1) Accept The Risk:- This is a good strategy to use for very small risks – risks that won’t have much of an impact on your project if they happen and could be easily dealt with if or when they arise. It could take a lot of time to put together an alternative risk management strategy or take act…[Read more]

1) FORGETTING ABOUT THE USER:- Companies usually forget the main reason why they are developing a product. Failing to include the user in the process often starts right at the beginning of the development process, Ideally, you want to have the user involved in the process of documenting user needs from the beginning.
2)FAILING TO DOCUMENT DESIGN…[Read more]

I will say the coin has two sides to it so in the same way the outsourcing also has its own advantages and disadvantages, In this case particularly I will say outsourcing is the best option because:-
1- Most of the times tasks are outsourced to vendors who specialize in their field. The outsourced vendors also have specific equipment and technical…[Read more]

I don’t have any experience in the industry, But I have similar experience in my senior year of Undergrad. In capstone class we have the status meeting every week with our professor and our adviser where the professor is our project manager and the adviser is our costumer, and we have to give him the status of the project and discuss the…[Read more]

I don’t have any industry experience in writing protocols but I have worked in the laboratory where I have done this, and for our study we have used the Gpower analysis. And based on that we decide how many subject we need for our study. To determine how many subject we need to get the reliable data it is very important, specially when you work in…[Read more]

Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and correcting errors through an iterative process of development. As a result, the end user benefits from a safe and effective product and the manufacturer benefits from a…[Read more]

I am in capstone 2 right now and I will say it is the best class in the entire curriculum we have at NJIT it gives you the idea that how you will be working in the Industry, it teaches you how to write these documents as an engineer and why it has to be idiot proof, can’t be vague and most important think DEVILS IS IN THE DETAILS. Design…[Read more]

Government agencies responsible for regulating Medical Devices in India.
1. The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals and medical devices.
2. The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the m…[Read more]

Design control is not required in EU, but I would say it is very helpful to have it, EU do have the Design Dossier/ Technical Files which king off go along with Design Control but it is not the same document as design control. Design control is very important document to have it if it required by the EU medical device regulation agency or not…[Read more]

Every Coin has two sides of it in the same way every clinical trials has advantages and disadvantages:-

Advantages :-
1. You may gain access during and after the clinical trial to new treatments that are not yet available to the general population
2. You may obtain medical care free of charge
3. You will be closely monitored for possible…[Read more]

I am currently doing capstone 2 at NJIT, we definitely do the testing of our design but we do not make the clinical trial Protocol. My project is to make the control cortical Impact device which is used to make an traumatic brain injury on the rat. So in this project we have created the test plan to test hardware and software requirements and we…[Read more]