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cef3
@cef3
Active Member
Joined: Nov 4, 2016
Topics: 1 / Replies: 17
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RE: NDA vs Patents

The thing is that what you may be working on (as covered by an NDA) may not be sufficient to be apply for a patent. You may in fact be needing work or...

8 years ago
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RE: Written Agreement v/s Verbal Agreement

The biggest difference between a written and oral contract is that a written contract can easily be defended in court, while an oral one requires addi...

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

Well, Dr. Simon, when I first signed enrolled in this class, I was expecting it to be really more about medical devices and theory that goes into that...

8 years ago
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RE: Forming a Project Team

It's been my experience that project teams are simply made by allocating personnel from each function that have less responsibilities with other proje...

8 years ago
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RE: Discussion Topic: Your organizational type

My work setting seems to fit best as a matrix-type of organization. There are functional departments as well as project teams and project managers. Ho...

8 years ago
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RE: Risk Identification

The way it was done in my previous job was to use a quality by design matrix. Critical quality attributes (CQAs) were determined based on the design i...

8 years ago
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RE: Risk management methods

Two other methods are: Hazard Operability Analysis (HAZOP) - Based on a theory that assumes that risk events are caused by deviations from the desig...

8 years ago
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RE: Expense of Regulations

I've wondered about this as well, especially because in academic research I've needed to look at ISO standards and I wasn't going to pay for them. I f...

8 years ago
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RE: Combination Product Phase I clinical Studies

This is an interesting question, which brings another question to mind: would design transfer activities even have begun at phase I clinical studies? ...

8 years ago
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RE: Minutes for meetings

I can only speak to my experience, but generally it's been as Roberto pointed out. Nobody really pays much attention to the minutes and they are more ...

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

If quality by design is used in the development of the product, a simple way to come up with tests for verification/validation is to just use characte...

8 years ago
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RE: Design Transfer

I disagree. For a smaller company, it is usually more cost effective to outsource manufacturing because they rarely have the infrastructure required f...

8 years ago
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RE: Design Transfer and Challenges

Many things can go wrong during transfer. For example, if the design specs heretofore have all been for a product made through a different process and...

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

It seems that the DHF is superior to the Design Dossier or Tech File in it's thoroughness and documentation and that is why there seems to be a move i...

8 years ago
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