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Forum Replies Created

RE: Benefits of this course

One of my friends had taken this course before and suggested it to me because it really helped with her knowledge of FDA regulations and when interviewers asked her about this. I had previously taken ...

In forum Project Management Process and Medical Device Development

8 years ago
RE: PM Internationally

There definitely will always be challenges communicating with international branches of the same company. As was previously stated, time differences, language differences, and cultural differences are...

In forum Project Management Process and Medical Device Development

8 years ago
RE: Work Breakdown Structure

Like many of the previous replies, a lack of communication and time has been one of the most prolific problems in the projects I've worked on. In one such project we had made an initial WBS that we wo...

In forum Project Management Process and Medical Device Development

8 years ago
RE: Underestimating Task Duration

I've experienced this during one of my internships. One half of the team was set to work doing programming for some output data from a technology no one had experience with (RFID chips), and the othe...

In forum Project Management Process and Medical Device Development

8 years ago
RE: Discussion Topic: What are the PM elements in your company?

I was once working on a small-scale project at Monmouth University where the project sponsor was the local fire department and my project managers in a sense were two professors. These made up the ent...

In forum Project Management Process and Medical Device Development

8 years ago
RE: Discussion Topic: Realities of Planned Value

One the biggest problems that can arise from an overestimated budget is of course layoffs. Not only will you lose employees who have been contributing to the project, the potential demoralizing effect...

In forum Project Management Process and Medical Device Development

8 years ago
RE: Discussion Topic: The critical path

When I was working with a 3D-printed foot orthosis project one of our side projects was testing out other possible materials to print it with. We had gotten all the way toward refining the final print...

In forum Project Management Process and Medical Device Development

8 years ago
RE: General Wellness Product

This may be a strange angle to take, but I think those "energy wristbands" that were a mild craze a while ago can be considered a general wellness product. These were ordinary bracelets that were adve...

In forum Introduction to Project Management

8 years ago
RE: LifeVest Wearable Cardioverter Defibrillator

For the mobile application, if the only function of the application was to show the heart rate I believe it still would be subject to FDA regulation. It certainly would have an easier time passing FDA...

In forum Introduction to Project Management

8 years ago
RE: Simulations

I believe having in-person meetings would definitely have made for a more efficient use of time. When you're part of an online class where you may not necessarily be able to meet with your group membe...

In forum Introduction to Project Management

8 years ago
RE: Validation vs. Verification

During one of my past internships I was part of a project where we had to program a website to monitor flooding. The verification of that project was essentially whether or not the website functioned....

In forum Introduction to Project Management

8 years ago
Potential FDA Changes under Trump

This concerns information we covered past in week 2 but I feel like this is a pretty relevant topic. Based on a recent executive order that Trump has made, it seems that Trump is trying to cut the amo...

In forum Introduction to Project Management

8 years ago
RE: Tests for validation and verification phase

For verification, it's important to note that tests aren't the only acceptable verification activities; a company can also utilize inspections and analyses for their requirements, which can sometimes ...

In forum Introduction to Project Management

8 years ago
RE: Thalidomide's Impact on Regulation and the FDA

My follow up question is, do strict policies stunt medical innovation and economic growth? This is a really good follow up question to think about. I believe strict policies do stunt medical innovatio...

In forum Introduction to Project Management

8 years ago
RE: Mobile Medical Applications

I find this point about the Fitbit app very interesting. I myself own a Fitbit and the associated app, and this app allows you to monitor various things such as sleep patterns, physical activity, and ...

In forum Introduction to Project Management

8 years ago
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