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smc24@njit.edu replied to the topic "Managing Problem Solving on Diverse Teams" – 2 months, 1 week ago
Fortunately, my group did not seem to run into any issues. However, we did run into a similar situation where everyone seemed to have a slightly different background. I believe it helped us as well. Our group was able to… Read more»
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smc24@njit.edu replied to the topic "The Importance of the Design History File (DHF) in Regulatory Compliance" – 2 months, 2 weeks ago
A Design History File (DHF) is essential for regulatory compliance, but a massive part of good project management as well. Any issues with regulatory boards will have drastic implications for the company in question. One of the best ways I… Read more»
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smc24@njit.edu replied to the topic "Managing Design Change Requests Effectively Without Disrupting Development" – 2 months, 2 weeks ago
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 wrong, but good project management will always plan for setbacks and… Read more»
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smc24@njit.edu replied to the topic "Caution with Medical Devices that Require a PMA" – 2 months, 3 weeks ago
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 capacity and resources. Innovation and new devices and treatments are essential to the medical field… Read more»
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smc24@njit.edu posted a new topic "Misclassification of a Device?" – 2 months, 3 weeks ago
Many devices exist in a sort of “grey area” where they could potentially be classified as one class or another, or at the very least experience overlap when it comes to the governing sub-agency of the FDA (CBER, CDER, CDRH)…. Read more»
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smc24@njit.edu replied to the topic "Pre-market Approval (PMA) vs. 510(k)" – 2 months, 3 weeks ago
Understanding the differences between these pathways is essential to Project Management since they drastically effect the timelines and requirements for projects that fall under them. Typically, a PMA will take the longest and it is required for any Class III… Read more»
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smc24@njit.edu replied to the topic "Balancing Stakeholder and Customer Values" – 2 months, 4 weeks ago
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 values would align in perfect harmony. However, as anyone can assume this is almost… Read more»
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smc24@njit.edu replied to the topic "How to communicate effectively between team mates in project team ?" – 2 months, 4 weeks ago
I believe there are three keys to effective communication: speed, detail, and situational awareness. Firstly, effective communication must happen as soon as possible. As soon as a need for communication is identified, I strongly believe an attempt at said communication… Read more»
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smc24@njit.edu replied to the topic "Role of Project Management in Medical Device Development" – 2 months, 4 weeks ago
You’ve certainly nailed the importance of Project Managment! To answer your proposed question, my experience definitely leads me to believe that rules and regulations are by far the biggest hurdle in any medical industry, including when it comes to medical… Read more»
