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Sumayia Chowdhury
@sumayia-chowdhury
Eminent Member
Joined: Sep 17, 2022
Last seen: Dec 14, 2022
Topics: 2 / Replies: 34
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RE: Discussion Topic: Quality Assurance vs. Quality Control

The difference between quality control vs. quality assurance is the activities involved. Quality assurance focuses on providing the confidence that yo...

1 year ago
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RE: Precision and Accuracy

The accuracy of the device qualifies how it performs in comparison to existing values. With precision, the FDA evaluates if the device is functioning ...

1 year ago
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RE: Combination Product

An example of a combination product is antibiotic-impregnatedbone cement (also referred to as antibiotic-loaded bone cement)releases the antibiotic ag...

1 year ago
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RE: Talking about animal research

Animal testing is an unfortunate reality for product assessments. The pain and suffering animals endure comes attached to the advancements and researc...

1 year ago
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RE: Approaches to Research

In academia, the research is done out of passion and interest and less focus is paid to monetary benefits. On the other hand, in industry, it's all ab...

1 year ago
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RE: Ethics of Animal Testing

It is not rational for researchers to test new treatments in humans before they have been tested and researched in lab animals. How disease works, and...

1 year ago
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RE: Dealing with risk

I agree with the previous discussion that many medical devices tend to have a risk, even if they are approved. And almost all of the drugs have some o...

1 year ago
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RE: Manage Risk

Medical Device Risk Management is a systematic approach of identifying, analyzing, evaluating, controlling, and monitoring all kinds of risk for a med...

1 year ago
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RE: Malsow's law in organization

The theory offers a basis for organizational development with high employee motivation to achieve company objectives. An organization that satisfies M...

1 year ago
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RE: For those that work in a matrix based organization:

In my opinion, one of the defining characteristics of a matrix organizational structure is that it: overlays two organizational structures in order to...

1 year ago
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RE: Organization types of medical devices?

Hi from last week's lecture about organizational development, we learned about three types of medical device organization. I would say, for the initia...

1 year ago
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RE: Design Verification & Validation

Validation can be defined as the process of evaluating a product to determine if the device satisfies the user requirements. In other words, Validatio...

1 year ago
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RE: Design Review Meetings

A design review meeting is done at the end of each phase. A design review meeting is a discussion that occurs among cross-functional teams to evaluate...

1 year ago
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RE: Why VERIFICATION is important? and Your ideas to improve Verification process ?

Design verification is essential to eliminate the potential failure of a product even in the early stage of the product development phase. With verifi...

1 year ago
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