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atk27@njit.edu
@atk27njit-edu
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Joined: Sep 6, 2023
Last seen: Apr 27, 2024
Topics: 4 / Replies: 59
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RE: Different Project Manger Approaches

There are different leadership styles that a PM can implement but it all comes down to whether they want to be loved or feared as a leader. Every good...

12 months ago
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RE: What are the significance of project sub plan in project management system ?

A detailed plan is always going to include sub-plans that require planning with different areas within the project. There are many different component...

12 months ago
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RE: V&V activities and the FDA approach

@nm523njit-edu The key requirement for this is to establish clear communication channels between project managers, regulatory affairs, and upper manag...

1 year ago
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RE: Regulation Number & Product Code for 510k

First, the adequate predicate of that device needs to be found which will be the first starting point to figure out the product code and regulation nu...

1 year ago
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RE: Combination Product Project Management

The main solution to this would be either getting outside help using consultations or educating yourself on the topic. It is crucial to learn the biol...

1 year ago
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RE: Project Management in the Biomedical Industry

Another topic that is unique to medical devices include a robust quality management system or ISO 13485:2016 standards. This standard requires that a ...

1 year ago
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RE: PDCA cycle in Biomedical Engineering

The PDCA cycle varies with different specialties and the companies but the overall principle provides the framework for how problems should be address...

1 year ago
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RE: Sizes of Project Teams

From a business standpoint, having a smaller and more experienced team is better than having a larger team where there is not enough work to go out to...

1 year ago
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RE: Advamed Guidelines

Events held in anything considered non-professional, especially in the context of medical industry, can be considered an unreasonable location. Events...

1 year ago
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RE: Verbal Contracts

Verbal contracts are still legally binding if they have elements of validity. The problem with verbal contracts though is that people misunderstand ea...

1 year ago
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RE: When is giving gifts like the "old days" too much?

There are also some restrictions where patients can not give gifts to their physicians to. It carries a risk of subtle biasing to the care of that pat...

1 year ago
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RE: Matrix Strength

The matrix completely depends on the organizational culture, project, and preference of the company overall. Where I currently work, most of the PMs d...

1 year ago
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RE: Upper vs Middle Management.

I'd say middle management, which includes any type of manager or director, because they have to maintain the operations of their team. More than that,...

1 year ago
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RE: Discussion Topic: Your organizational type

I currently work in a matrix organization as well and the program managers would recruit people from different departments for their program. This org...

1 year ago
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RE: Risk Acceptance

The thing is some risks are relatively minor and have a very low probability of occurring. However, high probability risks need to considered and appr...

1 year ago
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