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gaberuiz13 replied to the topic FDA on Recalled Items in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
Any medical device of any type can experience a recall for numerous different reasons. One prevailing issue that effects device such as sensor systems is the accuracy and precision of said medical device. Often times the FDA will shut down a company because their product is showing signs of lacking accuracy and precision in measurements. It only…[Read more]
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gaberuiz13 replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 7 years, 6 months ago
As the other before me have said, the biomedical device will have to comply with ISO 10993. This means that the medical device in question cannot harm a subject depending on the application. This can be viewed in the toxicity chart from this week’s lecture. You’ll have to narrow down your device into a category related to the body contact involved…[Read more]
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gaberuiz13 replied to the topic Approaches to Research in the forum Pre-clinical Device Development 7 years, 6 months ago
Research in academia is generally approached in the following manner: “I am curious about this subject and I want to delve deeper into it.” Research in academia generally stems from the thrill of discovery and requires a kind of passion that merits the possibility of no grand reward for hard work. Research in industry is approached in this manner:…[Read more]
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gaberuiz13 replied to the topic Research for the Fututre or Now? in the forum Pre-clinical Device Development 7 years, 6 months ago
I personally would prefer to do research that can be utilized as soon as possible. There is that sense of instant gratification where you can see what you have created and see it be applied in the ‘real world’. I feel that doing research that can only benefit future generations is a noble cause; however, it really depends on the researcher for…[Read more]
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gaberuiz13 replied to the topic Project Life Cycle in the forum Intro to Project Management 7 years, 6 months ago
I would say that the planning process is among the most important phases followed by the execution process. This is because the planning process is the time where a project’s execution is discussed and where all things leading up to the finalization of said project is also discussed and laid out so that every member of the team knows what to…[Read more]
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gaberuiz13 replied to the topic Project Management Softwares in the forum Intro to Project Management 7 years, 6 months ago
I never worked in industry, but for the Capstone class here in NJIT we used Microsoft Project in order to create an in depth schedule for our project. You’re able to use this in several views such as a Gantt Chart, Network Diagram, or just a simple calendar. You can even enter data and define milestones to better see the development of the project…[Read more]
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gaberuiz13 replied to the topic Discussion Topic: Project Management in a medical device setting in the forum Intro to Project Management 7 years, 6 months ago
One of the biggest challenges of doing project management for a medical device as opposed to building a building is having to assure that the device in question is meeting vigorous FDA regulations and that all other documents such as human testing applications and such are in order. The project manager is to assure that any documents such as…[Read more]
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gaberuiz13 replied to the topic Advice for Biomedical Engineering Students in the forum Introduction to Medical Device Development 7 years, 7 months ago
I personally never worked in the field, but I can share the advise other upperclassmen and advisors gave me. In my experience, landing an internship is not easy and from what I hear in some other fields may not be totally necessary. An upperclassmen told me that a BS in BME is quite valuable, so maybe for at least trying to get into industry,…[Read more]
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gaberuiz13 replied to the topic Discussion Topic: Academia vs. Industry in the forum Introduction to Medical Device Development 7 years, 7 months ago
If someone wanted to work in academia I would say academia is very research oriented and allows for great opportunities to discover new things and maybe even travel the world to share your knowledge. At the same time for academia, job security could be dependent on whether or not you are able to get funding for your research, but in the same vein,…[Read more]
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gaberuiz13 replied to the topic Discussion Topic: Practical vs. Informational courses in the forum Introduction to Medical Device Development 7 years, 7 months ago
The 3:7 ratio of practical classes to academic classes feels as though it is a missed opportunity; however, it could be worse. I’ll start by saying that I feel as though this ratio should be 1:1 or at least 4:6 or 6:4. This is because while academics are important, it is not going to prepare anyone for the actual job market. It is practically…[Read more]
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gaberuiz13 became a registered member 7 years, 7 months ago