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es338
@es338
Eminent Member
Joined: Jan 15, 2018
Topics: 0 / Replies: 42
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RE: Discussion Topic: Course conclusion and impressions

Dr. Simon, I appreciate the material that you are teaching in this class as it is extremely applicable to the industry. This course has allowed be to...

5 years ago
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RE: Anti-kickback & Stark Cases

False Claims Act violations can result in the following: • Damages penalty triples the amount of money defrauded from the government • Claim penalties...

5 years ago
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RE: Your Organizational prference; but why?

Currently, I work in a Matrix Organization which is project-based, where there is a representative per functional group that is responsible for succes...

5 years ago
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RE: Risk management and Labels

I am surprised to hear as well that instructions for use (IFU) and labels are deemed as the least effective way to solve residual risk since the amoun...

5 years ago
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RE: Sample Size Based on Risk Analysis

As hc225 mentioned, from experience in the industry, AQL levels are in place for the critical dimensions from the technical drawings of the product. Q...

5 years ago
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RE: Auditor's view of DHF / DHR

Hello, I have recently participated in a Medical Device Single Audit Program (MDSAP) audit and am currently preparing for the second part of the same ...

6 years ago
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RE: Consequences Of Insufficient Design Controls

Hello, General consequences of insufficient design controls: • Design not meeting the needs or wants of the intended market/customer • Faulty product ...

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

Hello, I have some experience developing Gantt charts through my undergraduate program and through industrial experience. From my perspective, some i...

6 years ago
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RE: Minutes for meetings

As a Project Coordinator who takes the meeting minutes from each meeting, I agree with Dr. Simon’s push on the importance of taking meeting minutes. M...

6 years ago
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RE: Deviations That Occurs During Verification

Through my experience working as a Project Coordinator in the medical industry, I have encountered a two verification tests that didn’t meet the desig...

6 years ago
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RE: Clinical Trial Roles

Guidance for Clinical Trial Sponsors: I would select to be a sponsor for clinical research because they are responsible for initiating the clinical i...

6 years ago
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RE: Brand Coloring

Marketing research indicates that approximately 80% of visual information is based on color and a person can only keep 3-4 pieces of information store...

6 years ago
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RE: Fuzz before launch of product.

From experience in the industry, the company’s Marketing lead for that project will reach out to their sales team in each region or country and have i...

6 years ago
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RE: WHAT IS MARKETING TO YOU?

Marketing is having the ability to understand the customer’s needs and wants and utilizing those specific tenders into design inputs and marketing out...

6 years ago
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RE: Public vs. Private Companies

Private companies, in my opinion, have more of a small business feel even though they can be very large in size. They have a small number of owners, t...

6 years ago
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