Forum

zmh4
@zmh4
Active Member
Joined: Nov 2, 2016
Topics: 0 / Replies: 15
Reply
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...

8 years ago
Reply
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...

8 years ago
Reply
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...

8 years ago
Reply
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...

8 years ago
Reply
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...

8 years ago
Reply
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...

8 years ago
Reply
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...

8 years ago
Reply
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...

8 years ago
Reply
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...

8 years ago
Reply
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 ...

8 years ago
Reply
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 ...

8 years ago
Reply
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...

8 years ago
Reply
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...

8 years ago
Reply
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 ...

8 years ago
Reply
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...

8 years ago