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Kamarian replied to the topic "Discussion Topic: Academia vs. Industry" – 2 years, 9 months ago
@amandaally1029 This is a great perspective to have if you have prior experiences in both the academia vs the industry. Now mainly most of the working experiences I have had is mainly in the academia arena and I don’t really… Read more»
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Kamarian replied to the topic "Discussion Topic: Academia vs. Industry" – 2 years, 9 months ago
@amandaally1029 This is a great perspective to have if you have prior experiences in both the academia vs the industry. Now mainly most of the working experiences I have had is mainly in the academia arena and I don’t really… Read more»
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Kamarian replied to the topic "Discussion Topic: Academia vs. Industry" – 2 years, 9 months ago
@amandaally1029 This is a great perspective to have if you have prior experiences in both the academia vs the industry. Now mainly most of the working experiences I have had is mainly in the academia arena and I don’t really… Read more»
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daryllynnn replied to the topic "Clinical Studies" – 3 years ago
Posted by: @amandaally1029 With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are… Read more»
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mmd55 replied to the topic "Clinical Studies" – 3 years, 5 months ago
Posted by: @amandaally1029 With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are… Read more»
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arianaburch replied to the topic "Public vs. Private Companies" – 3 years, 6 months ago
Posted by: @amandaally1029 What is the difference between public and private companies? Based on their differences, what are some pros and cons of each? Give an example of a private and public company, and state the successes. The difference between… Read more»
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ema25 replied to the topic "Discussion Topic: Practical vs. Informational courses" – 3 years, 7 months ago
@amandaally1029 I agree with you Amanda, there are definitely not enough practical courses being taught, at least that was my experience at the undergraduate level. While physiology and other academic courses are important, they will not always help in the industry…. Read more»
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mrlee5 replied to the topic "What is Risk-benefit analysis ?" – 3 years, 9 months ago
@amandaally1029 well said. Risk assessment is a very important consideration. It puts into perspective the severity and harmful events that can be associated with the use of the device. Deciding whether the risks are low, severe, or moderate can help… Read more»
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kbentleymsm-edu replied to the topic "Clinical Studies" – 3 years, 10 months ago
Posted by: @amandaally1029 With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are… Read more»
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djwhitemsm-edu replied to the topic "Public vs. Private Companies" – 3 years, 10 months ago
Posted by: @amandaally1029 What is the difference between public and private companies? Based on their differences, what are some pros and cons of each? Give an example of a private and public company, and state the successes. In my opinion… Read more»
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kbentleymsm-edu replied to the topic "Public vs. Private Companies" – 3 years, 10 months ago
Posted by: @amandaally1029 What is the difference between public and private companies? Based on their differences, what are some pros and cons of each? Give an example of a private and public company, and state the successes. I decided to… Read more»
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maniakberk replied to the topic "Clinical Studies" – 4 years, 5 months ago
Posted by: @amandaally1029 With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are… Read more»
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jwashin3 replied to the topic "Discussion Topic: Academia vs. Industry" – 4 years, 8 months ago
@amandaally1029 Having spent most of my career in the academic medical center setting, where pace and business activity more closely resemble industry, as well as the academic research setting, I would concur that the academic research side does provide much… Read more»
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JordanKayal replied to the topic "Verification Protocol" – 5 years, 4 months ago
Posted by: @amandaally1029 Verification is an important part in developing medical devices or products, and can really help in making sure the products set out to do what they are supposed to. For instance, take tylenol for example; the purpose… Read more»
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JordanKayal replied to the topic "Clinical Studies" – 5 years, 5 months ago
Posted by: @amandaally1029 With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are… Read more»
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JordanKayal replied to the topic "Public vs. Private Companies" – 5 years, 5 months ago
Posted by: @amandaally1029 What is the difference between public and private companies? Based on their differences, what are some pros and cons of each? Give an example of a private and public company, and state the successes.The main difference between… Read more»
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alexandrabuga replied to the topic "Discussion Topic: e-cigarettes" – 5 years, 10 months ago
As @thuytienlaco and @amandaally1029 stated, e-cigarettes are regulated by the FDA. In Aug 2016 the FDA finalized the rule extending CTP’s regulatory authority to cover all tobacco products, including electronic nicotine delivery systems (ENDS) that meet the definition of a tobacco… Read more»
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alexandrabuga replied to the topic Discussion Topic: Mission and Vision statements in the forum Marketing and Sales 7 years, 5 months ago
Medtronic
It’s important to have a vision and mission statement to provide direction, it is the foundation of a company. Vision is a general broad statement that communicates the company’s values. Whereas a Mission statement defines how the company will deem success- what the company needs to accomplish to consider it successful and is geared to…[Read more]
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alexandrabuga replied to the topic Discussion Topic: e-cigarettes in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
As @thuytienlaco and @amandaally1029 stated, e-cigarettes are regulated by the FDA. In Aug 2016 the FDA finalized the rule extending CTP’s regulatory authority to cover all tobacco products, including electronic nicotine delivery systems (ENDS) that meet the definition of a tobacco product.
As per 21 CFR Parts 201, 801, and 1100
Tobacco product…[Read more]