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mem42
@mem42
Eminent Member
Joined: Sep 7, 2018
Topics: 0 / Replies: 40
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RE: Discussion Topic: Course conclusion and impressions

I am very glad I took this course. It gave me the overview I needed to understand more of how things work in the industry. I know certain topics are m...

6 years ago
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RE: Restrictions for physician's gifts

I think the restrictions are not out of place. You are attending a business discussion and family members should not be involved. It should be underst...

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

An oral agreement can include forms of oral agreement and a written contract. A verbal agreement is made without a formal written documentation. While...

6 years ago
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RE: Upper vs Middle Management.

Personally, I think I would be suited for either one. Middle management is essential to understand the vision and I think this is where experience is ...

6 years ago
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RE: Forming a Project Team

As it's mentioned quite a few times in the previous posts, in a real-life scenario you most likely won't have the opportunity to finger pick the perso...

6 years ago
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RE: Discussion Topic: Your organizational type

Previously I worked in a project-based organization. Although I was just an intern, I got to experience how the projects were worked out within the de...

6 years ago
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RE: Risk management and Labels

Once the product is out in the market, and the company has done everything possible it is up to the user to use the product as indicated. The company ...

6 years ago
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RE: How to run a risk management meeting ?

Risk meetings should have an agenda that everyone is already aware of. This way all attendees know what the meeting will be about. I think breaking do...

6 years ago
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RE: What is Risk-benefit analysis ?

One of the factors is Assessment of the Benefits of Devices. In this assessment, the FDA takes into account the types of benefits that the device has ...

6 years ago
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RE: What are Design Controls?

Design controls have a specific objective and its to assure that the device meets the user needs, intended uses and specified requirements. Design con...

6 years ago
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RE: Design input sources

Design input sources can vary depending on what could be the most efficient way to obtain them. Many times, market analysis can offer significant inf...

6 years ago
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RE: Why VERIFICATION is important? and Your ideas to improve Verification process ?

I agree with the verification points mentioned above as well. Verification process makes an emphasis on attention to detail, to avoid major mistakes. ...

6 years ago
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RE: Design Documents in Academia

In research, documentation is also very important. Besides protocols, laboratory notebooks are highly useful because here it's where you can find spec...

6 years ago
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RE: Customer Needs and Design Input

Advantages of DID is that serves as an overall/general description of the product it also states the design input as clear and objective without numer...

6 years ago
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RE: Minutes for meetings

I agree that meeting minutes are highly useful. During my internship, I took minutes during meetings without being asked to. I found that directors li...

6 years ago
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