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zmh4
@zmh4
Active Member
Joined: Nov 2, 2016
Topics: 0 / Replies: 15
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RE: Consultants NDAs and CDAs

I believe that the consultant was in violation of an NDA or CDA, especially if this was not agreed upon by the other company he used to work with. I t...

9 years ago
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RE: Restrictions for physician's gifts

Hey Roberto, Good question. I think although it is too restricted, it is necessary. In my opinion, if two people are out to discuss business, then on...

9 years ago
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RE: Discussion Topic: Course conclusion and impressions

Hello Dr. Simon, I really enjoyed this course. In fact, it was probably the most useful course I have taken at NJIT, only because it is the only cour...

9 years ago
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RE: Project Management Preferences

Hi kdg4, You brought up a really good point. I agree that one of the hardest parts for a project manager is choosing individuals for their team in a m...

9 years ago
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RE: Organization types of medical devices?

In my opinion, it depends on the goal of the company, as well as the size. A small company may function best as a functional organization. That way, e...

9 years ago
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RE: Forming a Project Team

In my opinion, it is always best to work with someone who is most knowledgeable about the task they will work on. While maintaining good relations wit...

9 years ago
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RE: Expense of Regulations

I would have to disagree with most people on here. These regulations should not cost any money. There should be a standard set of rules that all compa...

9 years ago
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RE: Risk Management Mistakes

Hello, This is an interesting article. While I do agree that yes, companies can make these common mistakes, it still does not hurt to follow a proces...

9 years ago
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RE: Factors Contributing to Risk Values

Other factors would also be the probability of the occurrence; degree of harm caused by the failure; number of individuals affected and how exactly th...

9 years ago
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RE: When is validation is not required?

Human factors/usability engineering focuses on the interactions between people and devices. For medical devices, the most important goal of the human ...

9 years ago
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RE: Minutes for meetings

Meeting minutes are important because specific points can be made in a meeting that are important in moving the project forward. If we overlook those ...

9 years ago
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RE: Making up tests for design verification and validation

Hey Roberto, I agree with what everyone on this thread has said so far. However, I would also like to add that when "making up tests" it is often ben...

9 years ago
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RE: Design Controls for Legacy Combination Products

These products, although no longer under development, as you mentioned, are still being manufactured. If this is the case, then there exist documentat...

10 years ago
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RE: Design input sources

In my opinion, if you were to write a document on how to make a device, and give that document to someone else, they should be able to build an exact ...

10 years ago
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RE: Consequences Of Insufficient Design Controls

Hey Lamiaa, Good discussion question. I agree with all of the points on here. I just wanted to add also, that for a medical device, not following de...

10 years ago