@sn64 Hi sn64! I recently learned about a tool used at work to facilitate analysis regarding regulatory classification. The company one of my professors work for uses an AI-powered regulatory decision...

@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 functionality is the impact on long term performance a...

@archishak Hi there! While project management skills can be beneficial in many fields, I would actually argue against your post that a deep understanding of project management is not always necessary ...

@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...

@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 ...

@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...

@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...

@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...

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...

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...

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 ...

@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 ...

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...

@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...

@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...