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kmt29
@kmt29
Active Member
Joined: Oct 31, 2016
Topics: 0 / Replies: 14
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RE: Restrictions for physician's gifts

Excellent question; I think it’s very restricted, but the whole process is wrong. Why do the physicians have to take his wife to the business meeting ...

7 years ago
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RE: Consultants NDAs and CDAs

Everyone is making valid points; I do not have any similar experience but I do think the scenario that you gave is very interesting. My input on this...

7 years ago
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RE: Discussion Topic: Your organizational type

I would like to work in a functional organization because it will be easier to work on the project with the people in your department. Even though it ...

7 years ago
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RE: Organizational Behavior Management

The article you posted was very interesting. Currently at my job the organizational behavior is all over the place and it impacts the way we all opera...

7 years ago
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RE: Forming a Project Team

That is a tough question, but forming a great team is putting individuals together that are good at their roles, communication and other skills. I don...

7 years ago
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RE: Risk management and Labels

But if the patient can not understand the residual risk that means FDA is allowing products to go on the market with risks not described clearly in th...

7 years ago
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RE: Risk analysis in real company

I have no experience with risk analysis, but i think there is no major difference between the medical device and pharma world. After doing a little re...

7 years ago
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RE: Risk management and Labels

I do not think it is fair for companies do that to patients because they put them into so many health risk that are not safe especially if we look bey...

7 years ago
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RE: Important Part of DDP

That is a tough choice because all of those are very important to DDP! If I had to choose one it would be scope management plan; the reason behind tha...

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

I do believe that even if there are no changes after the verification the human factors evaluation is needed because it allows you to check the qualit...

7 years ago
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RE: Customer Needs, Business Requirements, Test Plan

I didn't do my undergraduate at NJIT ,but I believe it's common for a medical device to go through common steps. Those steps may just have a different...

7 years ago
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RE: Design input sources

Design inputs are very broad because every indivdual that may be on the team has different ideas. An example could be : -how much life span will this ...

7 years ago
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RE: Discussion Topic: Supplemental on DHF and DMR

At first before reading the other comments I thought that design control was needed in the EU, but I saw that it is not mandated unlike the US. The pr...

7 years ago
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RE: What are Design Controls?

Design controls are a set of methods used to complete/finish your design and it goes into more details are you all have already mention. The crazy thi...

7 years ago