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smc24@njit.edu
@smc24njit-edu
Eminent Member
Joined: Jan 26, 2025
Last seen: Mar 30, 2025
Topics: 2 / Replies: 21
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RE: The Importance of the Design History File (DHF) in Regulatory Compliance

A Design History File (DHF) is essential for regulatory compliance, but a massive part of good project management as well. Any issues with regulatory ...

2 months ago
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RE: Managing Design Change Requests Effectively Without Disrupting Development

I believe the best way to handle Design Change Requests is to plan for them in the first place. Obviously no one wants to plan for something to go wro...

2 months ago
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RE: Caution with Medical Devices that Require a PMA

I think this common practice clearly limits the potential for innovation in the medical field. The most obvious reasons to me are rooted in financial ...

2 months ago
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RE: Pre-market Approval (PMA) vs. 510(k)

Understanding the differences between these pathways is essential to Project Management since they drastically effect the timelines and requirements f...

2 months ago
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RE: Balancing Stakeholder and Customer Values

Balancing the values between stakeholders and customers is what I would call being stuck between a rock and a hard place. In a perfect world, all valu...

2 months ago
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RE: How to communicate effectively between team mates in project team ?

I believe there are three keys to effective communication: speed, detail, and situational awareness. Firstly, effective communication must happen a...

2 months ago
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RE: Role of Project Management in Medical Device Development

You've certainly nailed the importance of Project Managment! To answer your proposed question, my experience definitely leads me to believe that rules...

2 months ago
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