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Forum Replies Created

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 and real-world clinical usefulness. Although the FDA...

In forum Introduction to Project Management

5 months ago
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), I found it quite useful when organizing one for ...

In forum Introduction to Project Management

5 months ago
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 recount a personal experience with this. While I was i...

In forum Introduction to Project Management

5 months ago
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 goals or reallocating tasks shouldn’t be the initia...

In forum Introduction to Project Management

5 months ago
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 that overcoming disagreements through clear communi...

In forum Introduction to Project Management

5 months ago
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 teams typically offer efficient communication and qu...

In forum Introduction to Project Management

5 months ago
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 compatibility with project objectives. This evaluation incl...

In forum Introduction to Project Management

5 months ago
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—significantly impacts a project's success. Based off my ...

In forum Introduction to Project Management

5 months ago
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 flexibility and teamwork. By dividing the project ...

In forum Introduction to Project Management

5 months ago
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 address this awkwardness might be to have clear comm...

In forum Consultants and Legal Basics

7 months ago
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 ensures that all parties are on the same page rega...

In forum Consultants and Legal Basics

7 months ago
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 collect necessary data. Without an NDA, it is true th...

In forum Consultants and Legal Basics

7 months ago
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 integrate cutting-edge technologies. In fields regardi...

In forum Organizational Development in Device Companies

7 months ago
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 as "everyone does all tasks" is suitable for smal...

In forum Organizational Development in Device Companies

7 months ago
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 is primarily responsible for task execution and ens...

In forum Organizational Development in Device Companies

7 months ago
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