Activity | bb254 | Medical Device Courses

bb254 replied to the topic Toxic Medicine in the forum Introduction to Project Management 8 years, 4 months ago

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 teething products to verify that the input they state is the same as the output. Since we know it is not the…[Read more]

bb254 started the topic Combination Products in the forum Introduction to Project Management 8 years, 4 months ago

According to the FDA, a combination product is the combination of a drug and a device. It can include two or more dependent products either packaged together or separately. An example would be an insulin injector pen which diabetic patients use to control their glucose levels.

Based on our lecture or online articles what are the necessary…[Read more]

bb254 replied to the topic Mobile Medical Applications in the forum Introduction to Project Management 8 years, 4 months ago

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 sounds frequencies they can or can not hear. This app allows the user to check their hearing without the use of the Audiometer…[Read more]

bb254 replied to the topic Meat without Murder in the forum Introduction to Project Management 8 years, 4 months ago

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, a class 3 is marketed as a high risk device. Any high risk device requires Pre-market Approval and…[Read more]

bb254 replied to the topic Discussion Topic: GMP's in the forum Introduction to Project Management 8 years, 4 months ago

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 which is harmful or not effective. Since the GMP regulations are supported by law, the…[Read more]

bb254 replied to the topic Discussion Topic: State of your Organization in the forum Introduction to Project Management 8 years, 4 months ago

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 for Gait Analysis, neuroimaging and exoskeleton. Within each sector their were individuals that carried a…[Read more]

bb254 replied to the topic Discussion Topic: Projects of all types in the forum Introduction to Project Management 8 years, 4 months ago

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 their are differences on the pace of deliverables and environment. According to our…[Read more]

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