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pt58
@pt58
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Joined: Nov 1, 2016
Topics: 0 / Replies: 15
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RE: Restrictions for physician's gifts

Almost all companies have an ethics/gift-giving policy in place. In these policies some of them allow you to take a client to a business dinner as lo...

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

This course provides valuable insight to what is expected in the medical device industry. As someone who has taken all of Dr. Simons courses I can hon...

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

“Despite popular belief, oral contracts are enforceable. They usually are not in your best interests, and end in a "he said, she said" battle. But as ...

7 years ago
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RE: Organizational Behavior Management

I think being able to recognize this for your employees is a skill that is absolutely necessary in the hiring process when considering someone for a m...

7 years ago
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RE: Organizational structure and Culture both leading to project success?

I agree organization does influence company culture to an extent. However, I do think work culture is a big part of retaining employees. You want your...

7 years ago
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RE: Discussion Topic: Your organizational type

Functional, project-based, and matrix organizations all have their individual advantages and disadvantages, as discussed per this week’s lecture. Most...

7 years ago
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RE: Risk management and Labels

Our company offers several videos and training sessions that come with our product. The Training courses are, in my opinion, the best way to properly ...

7 years ago
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RE: Usability Risk Analysis

I think it is important to look at risk from several different methods. My company uses a Risk Management Summary, Failure mode, effects and criticali...

7 years ago
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RE: Risk analysis in real company

In the position I am currently in I do a lot of Risk Analysis. This usually stems from investigations that open up when we are faced with a high failu...

7 years ago
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RE: Factors to Consider While making Gantt Chart

The two common tools for project management schedule development are the Gantt and PERT chart. Both of these are great resources for planning and disp...

7 years ago
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RE: Design Review Meetings

I do agree with you “Reviews can be formal or informal, require a well-prepared agenda, and can last hours, days, or even a few weeks.” However, this ...

7 years ago
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RE: Minutes for meetings

Meeting minutes are used as documentation so that any attendee, or persons not present, that looks at this document can understand the basics of what ...

7 years ago
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RE: Design Verification & Validation

Like most of you mentioned before Validation and Verification are similar but the are not the same. In the verification process you are asking yoursel...

7 years ago
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RE: Consequences Of Insufficient Design Controls

Unless your product has already been on the market, the FDA will not allow you to take your product to market if your Design Controls are not deemed s...

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

“The DHF is mandated by the U.S. FDA, and describes a product through its development cycle, under Design Control, with its output being the DMR (Devi...

7 years ago