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archishak
@archishak
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Joined: Sep 5, 2023
Last seen: Apr 17, 2024
Topics: 0 / Replies: 71
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RE: FDA's Quality System Regulation

The FDA’s QSR part 820 outlines the requirements for maintaining the quality, safety, and effectiveness of medical devices. It also ensures that the m...

1 year ago
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RE: Measurement System Analyses During Testing Pre-Approval

Although testing is a significant component of the slowdown behind the FDA process of medical devices, other components also impact the deceleration o...

1 year ago
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RE: Difference in Biocompatibility testing

Some biocompatibility testing techniques include cytotoxicity testing, hemocompatibility testing, and implantation testing. All of these testing metho...

1 year ago
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RE: When researching, are you Academia or Industry?

The research path for making medical devices depends on the career goals an individual is trying to achieve. In terms of academia, the research for me...

1 year ago
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RE: Skills to get into research

Both academia and industry research are vastly different but similar in some aspects. For academia, expertise in grant writing and deep research skill...

1 year ago
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RE: Project Management Strategies in Academia

Although academia and industry are quite different, they both use project management strategies to reach their end goal. It is true that in industry t...

1 year ago
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RE: PM stakeholders benefits

In my opinion, the most affected stakeholder group would be the investors. Factors such as revenue and press recognition would affect the investor's f...

1 year ago
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RE: Quality and Risk Management in the Project Life Cycle

There are multiple ways one can ensure that the quality of a project is being held to a certain standard and that the risks are being adequately mitig...

1 year ago
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RE: Application of Biomedical Engineering

I believe that as a major, BME is facing the issue of not being broad enough. At NJIT students are encouraged to choose their track (biomaterials, bio...

1 year ago
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RE: Software engineering addition to Biomedical Engineering

Like many others, I agree that students in BME should be familiar with various coding languages. However, it also depends on the type of specializatio...

1 year ago
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RE: Improvements in Telehealth through Medical Devices

Although Telehealth has provided more access to healthcare, I believe it also has caused more harm. After having the opportunity to shadow different c...

1 year ago
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