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tm422
@magstiff
Trusted Member
Joined: Sep 2, 2024
Last seen: Apr 28, 2025
Topics: 1 / Replies: 78
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RE: FDA Approves First Digital Pill in USA

@anthony Hi Anthony! That is a very valid concern. The endorsement of Abilify MyCite highlights an important disparity between regulatory adherence an...

8 months ago
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RE: The Importance of the Design History File (DHF) in Regulatory Compliance

@bryan-xavier Hi Bryan! I certainly agree. Utilizing a traceability matrix is a fantastic method to keep organization in the Design History File (DHF)...

8 months ago
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RE: Misclassification of a Device?

@mjc22 Hi there! I agree with you that filing for FDA approval of a misclassified device can cause major hinderances to the entire process. I can reco...

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

@sn64 Hey sn64! Although empathy and comprehension are essential characteristics for a project manager, I would also like to make note that altering g...

8 months ago
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RE: Handling Conflicts Among Team Members Effectively

@benjaminrofail Hi Ben! You make a good point about how conflicts can either strengthen or weaken a team, depending on how they are handled. I agree t...

8 months ago
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RE: Sizes of Project Teams

I find that collaborating in teams of varying sizes presents distinct benefits and challenges. During my time in the military, I noticed that small te...

8 months ago
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RE: Transitioning to New Technologies During an Ongoing Project

When presented with new technology during a project, a project manager should carefully evaluate their possible effects by considering their compatibi...

8 months ago
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RE: Different Project Manger Approaches

During the lecture, we explored different organizational structures, and I think the leadership style—whether it be hands-off or micro-managing—signif...

8 months ago
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RE: Project Success and Scope Creep

@ms3548 This is a thoughtful question! I think that Agile approaches are very efficient in handling changing project objectives since they prioritize ...

8 months ago
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RE: Restrictions for physician's gifts

Hi Roberto, I agree with you that these situations can feel awkward especially when the intent is simply to show professional gratitude. One way to ...

10 months ago
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RE: Written Agreement v/s Verbal Agreement

@cef3 You make a valid point however, I would argue that even legal action seems unlikely, having a contract is still strongly beneficial. A contract ...

10 months ago
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RE: NDA vs Patents

@cef3 You make a good point! An NDA is surely an important piece in the early stages of development especially when engaging with collaborators to col...

10 months ago
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RE: AI & IoT in medical device industries.

It is clear from our class lectures that organizational development (OD) is very important in assisting medical device manufacturing companies to inte...

10 months ago
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RE: Organization Type vs. Effectiveness

Based off my experience in industry, I believe that the ideal organizational layout varies based on the company's objectives. A flexible approach such...

11 months ago
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RE: Upper vs Middle Management.

I believe I have the potential to succeed in both positions in the long run, but I envision myself beginning in middle management. Middle management i...

11 months ago
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