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nm523@njit.edu
@nm523njit-edu
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Joined: Sep 3, 2021
Last seen: Apr 14, 2024
Topics: 9 / Replies: 62
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RE: Importance of Culture in Project Management

I think there are multiple levels to the culture that an employee will experience in a company. On the smallest level there is the peer-peer relations...

1 year ago
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RE: Challenges in Managing Medical Device Projects

Medical device development is indeed a unique industry that requires very unique project management and creative decision making in order to comply wi...

1 year ago
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RE: Non-compete agreements

I have never encountered a non-compete agreement but I have been asked to sign non-disclosure agreements. Does anyone know the difference between the ...

3 years ago
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RE: What are the limitations and protections of trade secrets?

Additionally, a trade secret only works if no one else comes up with the same idea, recipe, design, etc. on their own. If another company is able to r...

3 years ago
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RE: Controversy regarding Advamed Guidlines

It is customary in medical device companies to allow for meals with health care professionals (HCP) where the company representative will pay for the ...

3 years ago
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RE: Different Organizations for Different Industries

In the last two years, I have noticed a shift in medical device companies organizational structure and a push from my company's management to transiti...

3 years ago
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RE: For those that work in a matrix based organization:

Juggling multiple projects is definitely challenging, but it can be really beneficial to have your hands in several initiative in the company as you c...

3 years ago
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RE: Seniority and Old Habits Vs. Newbies and New Techniques

I have noticed that in recent times most companies are trying to be more inclusive of diverse perspectives, including younger professionals, although ...

3 years ago
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RE: Two Types of Risk

Internal risks are easier to identify and manage than external risks. An example of internal risk can be in the QA inspection method implemented. If t...

3 years ago
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RE: Risk Management

As mentioned above, there are clear advantages to risk management that makes it absolutely necessary for product development and launch. However, ther...

3 years ago
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RE: What is risk control? What are some examples of risk control measures taken?

Another form of risk control may be in restructuring manufacturing processes. Therefore the risk management is not necessarily redesigning the product...

3 years ago
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RE: Design "Overvalidation"?

Typically, several inputs are determined based on the customer needs provided by marketing and the VOC evaluation done by R&D. These inputs are th...

3 years ago
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RE: Designing Verification Tests

Another factor to consider in verification activities is testing conditions that the actual product will undergo. This is not to be confused with vali...

3 years ago
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RE: Validation vs Verification

My experience with design verification and validation is that both activities must have strategies developed in the planning phase of the project. For...

3 years ago
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RE: Validation Types

@mmd55 As you mentioned, TMV are important for proving that the way we are testing the medical device is accurate and consistent, ensuring the decisio...

3 years ago
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