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tm422
@magstiff
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Joined: Sep 2, 2024
Last seen: Mar 26, 2025
Topics: 0 / Replies: 67
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RE: Regulation Number & Product Code for 510k

@sn64 Hi sn64! I recently learned about a tool used at work to facilitate analysis regarding regulatory classification. The company one of my professo...

2 months ago
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RE: Determining Spec

@amm7 I agree that finding the right balance between tight and loos specification is very important however I would also like to note that beyond func...

2 months ago
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RE: Project Management for Non-PM Positions

@archishak Hi there! While project management skills can be beneficial in many fields, I would actually argue against your post that a deep understand...

2 months ago
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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...

2 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)...

2 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...

2 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...

2 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...

2 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...

2 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...

2 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...

2 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 ...

2 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 ...

4 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 ...

4 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...

4 months ago
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