I have used FMEA extensively and consider it to be extremely productive. Specifically, a design FMEA allows the device or part to be analyzed on a feature by feature basis. Each feature is evaluated and assigned a risk value. This…   Read more»

The fact that the risk management file is a living document is one of the most important aspects of this area. Risk management is a constant cycle of analysis, evaluation, management, and measurement. This process continues far beyond the release…   Read more»

I think one of the most interesting risk factors is the probability of a harmful event. The FDA factors the proportion of the intended population that would experience that event and how many times it would occur. It is important…   Read more»

I believe that upper management should have a better idea of the overall function of the company. They should be knowledgeable about the goals and future of the company. It is also important to have some experience in middle management…   Read more»

FOrming a project team can prove to be difficult but I will share some of my observations. It is sometimes good to form a team which with you have a good relationship. You are aware of the extent of their…   Read more»

Hello. I am writing this discussion late so I have the benefit of having completed the Medical Device Development Project. I had the role of regulatory and was in charge of completing the regulatory rationale. I think one of the…   Read more»

Interesting topic. I was not aware of such restrictions on physicians. I think the idea of these restrictions is to maintain a sense of integrity and professionalism in the medical field. Physicians are often directly responsible for the health and…   Read more»

Consultants can be extremely beneficial if a company requires advice in a specific field or niche area. I believe the main benefit of hiring a consultant is the lack of need to train this person in said field. In most…   Read more»

The main thing to consider before signing is the contents of the NDA. Specifically, what restrictions does the NDA impose on you. NDAs are an agreement between the employer and employee to protect trade secrets and confidential information. The company…   Read more»

Due to the importance of the NDA and the terms it mandates it is important to fully understand and be in agreement with whatever you are signing. I also agree with seeking legal help to fully understand the terms you…   Read more»

Although I agree with some of the point mentioned by you guys, but is there more information regarding the job firing? Is it due to poor performance, disciplinary action or simply because they wanted too? I dot think this is…   Read more»

Although I agree with some of the point mentioned by you guys, but is there more information regarding the job firing? Is it due to poor performance, disciplinary action or simply because they wanted too? I dot think this is…   Read more»

The difference between a patent and a NDA is that a patent is a federal document proving ownership of an idea, while an NDA is a contract between two people. In other words, NDA’s recognize the people whose signatures are…   Read more»

This class was extremely informational. I really enjoyed the amount of different topics we delved into. During undergrad at NJIT, I feel like the only course that really introduced me to industry-related topics was capstone, since it involved working on…   Read more»

A verbal contract can include any agreement with words, which includes both oral and written agreements. Because of this, we should compare written contacts to spoken contracts. In every sense, a written contract is the most reliable contract when starting…   Read more»

I currently work as a Technical Writer for a company that offers healthcare technology solutions such as biomedical equipment rentals, technology management, as well as technical service for hospitals and medical facilities. Since my company is ISO 13485 certified, we…   Read more»

I have signed many NDA’s and my advice is to read the entire document carefully prior to signing. After signing, I strongly advise asking exactly what details are bound by the NDA. Sometimes an NDA covers a lot of information…   Read more»

My company recently acquired a contract which would increase our business by 35%. My department was reallocated to help build the infrastructure for the company to successfully operate this new business venture, and it all began by signing an NDA….   Read more»

Non-Disclosure Agreement only gives a limited level of protection but a patent offers you a legally binding, enforceable-by-stiff-penalties PROOF of idea ownership. An NDA can provide you with a level of protection. In fact, if someone signs an NDA with you…   Read more»

I really like the way this course helped me to realize the path after my Master’s. I was not aware of most of the information taught in this course 3 months ago. Now I have an idea of how the…   Read more»