One issue that all project managers face is being able to keep communication between different departments or people. Information distribution such as sending emails and phone calls to people to get updates on certain assignments is a big task. Sometimes,…   Read more»

For our online simulation a project manager will have to priorities time management. Since the assignment is given a time limit of a week a project manager would have to take into account the team members work/ school schedule and…   Read more»

Missing milestones creates setbacks a lot of the time which can be harmful to a company rather than beneficial. I understand when you say that it might be beneficial to a company because your working on perfecting the device before…   Read more»

Since starting at Maquet I never actually knew what I would be doing as a manufacturing engineer in industry. I heard about the FDA maybe once or twice as an undergraduate.This course taught me so much about working as an…   Read more»

When a test on whether the balloon system pops after 10 days fails for a device such as ReShape Integrated Dual Balloon System it creates a stir in the office. I would like to share my experience on when a…   Read more»

For my capstone project to build a robotic arm control we had to use the work breakdown structure to outline the hierarchy of tasks. In order to build our controller we divided the responsibilities into mechanical, electrical and software. All…   Read more»

This week’s lesson speaks volumes to my experience with highlighting the critical path. So during my senior design course I encountered numerous obstacles which affected our critical path. I and my two friends were supposed to design a controller using…   Read more»

A budget cut will affect the cost estimation of a project because if in development stages of a product the budget is cut the project team has to reanalyze the scope of the project. Project managers will need to remain…   Read more»

When working on the creation of a seven degree of freedom impedance controller for an iARM my project team encountered many delays due to a critical path. The controller was initially expected to be controlled using an RS232 shield with…   Read more»

I would classify the Zoll Lifevest as a class 3 device because it has really high risk and it is used to help sustain life. The lifevest device begins to apply high energy shock during life threatening scenarios of ventricular…   Read more»

A lot of college students undergo a large amount of stress and are always trying to find ways to get more sleep. The sound + sleep product promotes “relaxation, renewal and deeper sleep.” It is a general wellness product because…   Read more»

Center of device & radiological health (CDRH) definition of a general wellness products as “Products that are intended for only general wellness use and present a low risk to the safety of the user.” Based on this definition, I do…   Read more»

The beginning stages of a project are always the most critical and research focused. It is viewed as the hardest section out of the nine design controls because you only have an idea of what you want. It is crucial…   Read more»

Within my senior capstone course I utilized many of the design control requirements without even realizing it. My capstone team developed a seven degree of freedom impedance controller for an intelligent assistive rehabilitation manipulator (iARM). We had to create a…   Read more»

In order to gain the FDA approval the company would have to recheck their design specification document, which would state the detailed spec of the product. The company would be required to then check the amount of belladonna within the…   Read more»

Based on the definition you provided I do believe that the app your team developed in capstone is considered to be a mobile medical app. Your app allows for a mobile user to check their auditory cues and identify which…   Read more»

If this method of murderless meat is viewed highly enough to raise the claim of developing artificial organs which would be used for patients that needed transplants,then by FDA regulations it is a class 3.According to our lecture this week,…   Read more»

According to ISPE, Good Manufacturing Regulations were created by the FDA to ensure that manufacturers take the proper steps to validate their products safety, purity and effectiveness. With these regulations the consumer is less at risk of receiving a product…   Read more»

When I worked at Kessler Foundation in the summer I realized that it was a project based organization, due to the fact that the Human Performance Lab was divided into separate units based on the different projects. Their were sectors…   Read more»

Project Management has a general process such as identifying requirements of the project, creating clear objectives, balancing demands of time, cost and quality. However, it would be different for a project manager from one industry to switch into another because…   Read more»