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djr32 posted a new topic "Integration PM" – 6 years ago
For my capstone, we had one main project of developing a mobile application. However, within this one project, we had different mini projects which were put together at the end to become one mobile application. One project was developing the… Read more»
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djr32 posted a new topic "Combination Product" – 6 years ago
A while ago we studied about combination device, which may include two or more separate products packaged together or includes products sold separately but intended for use with another type of product. Find a combination device and explain what it… Read more»
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djr32 posted a new topic "FDA Recall…Now What?" – 6 years ago
On March 31 of this year, the FDA recalled Mylan’s EpiPen and EpiPen Jr Autoinjector products used for emergency treatment of severe allergic reactions. The product is recalled because of a defective part that could result in the device’s failure… Read more»
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djr32 posted a new topic "Cost Analysis of Project" – 6 years ago
In this week’s lecture, we learned about planned value and actual cost. Planned value is the value of the work you are supposed to have on a certain date. While the actual cost is the cost of the project actually… Read more»
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djr32 posted a new topic "Importance of Logging Work" – 6 years ago
According to the lecture for this week, logging work is important because it can be usefully when new employees come to work on the project or when starting a new project, logs can help as a guidance of not making… Read more»
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djr32 posted a new topic "Challenges PM face" – 6 years ago
What is one challenge project managers face when handling a project? How would the project manager handle those challenge?
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djr32 posted a new topic "Are Missed Milestones really Bad?" – 6 years ago
We all know missing a milestone in a project is the worst thing that can happen. Not only are we set back our project a couple of weeks, months or maybe years, but the company loses money. Missing a milestone… Read more»
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djr32 posted a new topic "In the Shoes of a Project Manager" – 6 years ago
In last week’s lecture, we learned about the term Work Breakdown Structure (WBS), which a hierarchical breakdown of tasks performed for the project and we learned about the importance of a Gantt Chart. Suppose you are the project manager in… Read more»
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djr32 posted a new topic "Revising a Gantt Chart" – 6 years ago
In 2015, the FDA approved the ReShape Integrated Dual Balloon System. This is a device that is a weight-loss system of a gastric balloon that occupies in the stomach. The system consists of two attached balloons that are filled and… Read more»
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djr32 posted a new topic "Missing a Milestone Experience" – 6 years ago
This week we learned about the importance of a Gantt chart and how it allows project managers to highlight the critical path of a project. Think of a project that followed a specific Gantt chart. Share a time when you… Read more»
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djr32 posted a new topic "Experience Breaking Down A Project" – 6 years ago
In this week’s lecture, we learned about the term Work Breakdown Structure (WBS), which a hierarchical breakdown of tasks performed for the project. I have not yet had the opportunity to work in industry, but I did take part in… Read more»
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djr32 posted a new topic "LifeVest Wearable Cardioverter Defibrillator" – 6 years ago
Zoll LifeVest is a wearable cardioverter defibrillator to monitor and treat dangerous abnormally fast heart rhythms. These abnormal rhythms can lead to a complete absence of heartbeat and death if not treated. Thus the LifeVest treats abnormal rhythms by applying… Read more»
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djr32 posted a new topic "General Wellness Product" – 6 years ago
According to the FDA, general wellness products are “(1) intended for maintaining or encouraging a general state of health or a healthy activity or (2) an intended use that related the role of a healthy lifestyle with helping to reduce… Read more»
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djr32 posted a new topic "Fitbit: A Medical-Grade Device?" – 6 years ago
Fitbit is a consumer product that has the intention of tracking one’s daily fitness, heart rate, and blood pressure. However, there are people who filed a lawsuit against this company. The plaintiff David Urban bought a Fitbit PurePulse Tracker to… Read more»
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djr32 posted a new topic "Toxic Medicine" – 6 years ago
In the article, FDA: Toxic Belladonna In Homeopathic Teething Product, the FDA found that Hyland’s homeopathic teething products had belladonna, which is a toxic chemical, a level far exceeding the amount claimed on the label and asked the Standard Homeopathic… Read more»
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djr32 posted a new topic "Experience with Design Control" – 6 years ago
From this week’s lecture, there are multiple steps in a project cycle. Describe a time when you took part in a project in industry or in school. What design controls did you take part in the project? Was your experience… Read more»
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djr32 posted a new topic "Initiating a Project Idea" – 6 years ago
From the lecture, there are 9 parts to design controls. Why is initiating a project idea the hardest part of project development? How does business and market research play an important role when initiating a project idea? What are some… Read more»
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djr32 posted a new topic "Meat without Murder" – 6 years ago
A Brooklyn startup company, Modern Meadows, has a technique to develop meat without killing any animals. The process they use to make this meat is by incorporating fetal bovine serum, which is the blood drawn from the fetus of a… Read more»
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djr32 posted a new topic "Mobile Medical Applications" – 6 years ago
When you open your Google play store or Apple Store, you can find an app for everything, even things related for medical purposes, such as an app that measures blood pressure. Moreover, the FDA has regulation for apps that are… Read more»
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djr32 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial 8 years ago
I would personally like to have my end goal to be a manager, but I first would want to get a couple of years working as an engineer to understand how the industry actually works. This semester we learned many important concepts of FDA regulation and how the project management process works. This is important background basis for a project…[Read more]
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