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Ibraheem Shaikh
@ibraheem-shaikh
Eminent Member
Joined: Sep 8, 2017
Topics: 0 / Replies: 40
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RE: Design Controls in the other countries

As Rashed mentioned, no medical device regulations whatsoever existed in India before 2005. It's pretty stunning to consider that such a large market ...

7 years ago
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RE: Ethical Issues with Clinical Trials

As Dave mentioned above, one essential aspect of allowing risky clinical trials is letting patients who are using them as a last resort go through wit...

7 years ago
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RE: Informed consent: What if Henrietta Lacks checked No for research use?

We all agree that consent is incredibly important. However, when it comes to being paid for research, I think it is essential to consider the money in...

7 years ago
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RE: Double Blind Vs Single blind Study

The biggest determining factor in performing a single or double-blind study is the feasibility of doing so. While a single-blind study is almost alway...

7 years ago
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RE: The Expert

This comedy sketch illustrates a couple fundamental problems faced by many businesses, including those in the medical device development industry. Fir...

7 years ago
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RE: Manipulation or no?

There's no fundamental difference between persuasion and manipulation, in my opinion, except for perhaps maliciousness. Under this way of looking at i...

7 years ago
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RE: Fuzz before launch of product.

I want to second Ronak in that it is unfair to compare a generic medical device company to a giant like Apple that makes products aimed at the general...

7 years ago
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RE: Accepting job based on company.

As Gabriel said, choosing a job can be difficult for newcomers. As such, a decision to join a company based on its specific characteristics is often a...

7 years ago
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RE: Discussion Topic: Exercise your research skills

Intel, the well-known chipset manufacturer, has published the following metrics (all of which are TTM, or the "trailing twelve months" data). Intel h...

7 years ago
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RE: S-Corp vs C-Corp

People generally don't think of corporations as "subchapter s" or "c-corps" primarily because most large corporations people see are C-Corporations. A...

7 years ago
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RE: What are some ways Document Control can improve?

Document control is also essential to prevent information loss. It’s not unheard of for a particularly knowledgeable employee’s loss (due to any reaso...

7 years ago
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RE: Discussion Topic: The cost of Quality

One common bias found in the business world is "Discounting the Future." This bias prevents people from seeing the value in future investments and cau...

7 years ago
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RE: Your Ideas about Improving Quality Control

I believe Scott's first point - that everyone must buy into a "culture" of quality - is extremely essential. A number of workplaces will have a "not m...

7 years ago
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RE: Precision and Accuracy

The FDA is responsible for ensuring the safety of biomedical devices that are available in the United States. Precision and accuracy are both factors ...

7 years ago
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RE: Changes in FDA under Trump's Administration

Cheaper medical device registrant fees are effectively subsidies to the medical device industry. The utility of such subsidies seems significantly hig...

7 years ago
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