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yg385 replied to the topic "Choosing A corporation" – 5 months, 3 weeks ago
@as934 , reading through the other posts, agree this point is not mentioned and is a good one to consider. Tying into this point, the type of corporation chosen also depends on the future intent of the individuals attempting to start this… Read more»
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jteamer replied to the topic "Consultants in the Medical Device Industry" – 3 years, 9 months ago
Posted by: @as934 While consultants can provide many different areas of expertise, the consultants that I have come across during my career in the medical device industry have mostly been experts in regulatory compliance. Companies may hire compliance consultants to… Read more»
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jteamer replied to the topic "Discussion Topic: The Fifth "P" of Marketing" – 3 years, 10 months ago
@as934 The use of social media to create an interactive platform is increasingly becoming common practice to utilize social media for marketing and increase possible consumers’ participation. Especially more prevalent with quarantine and COVID restrictions. I have not personally seen… Read more»
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k-faulk replied to the topic "Things to look for in a contract while selecting a supplier" – 3 years, 11 months ago
Posted by: @as934 One of the most important things to have included in a vendor contract is the condition that they need to notify your company about any changes that they have made or are going to make to the… Read more»
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jaf22 replied to the topic "Meeting Deadlines with Research" – 4 years ago
Posted by: @as934 In this week’s Simulation 2, we are working for a company called BoneFix, which is partnering with company called FactoSet to create a competitive product that delivers a growth factor that aids in bone regeneration. BoneFix has… Read more»
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ktk4njit-edu replied to the topic "Meeting Deadlines with Research" – 4 years ago
Posted by: @as934 In this week’s Simulation 2, we are working for a company called BoneFix, which is partnering with company called FactoSet to create a competitive product that delivers a growth factor that aids in bone regeneration. BoneFix has… Read more»
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sin3 replied to the topic "Safety Recalls" – 4 years, 1 month ago
Posted by: @as934 My question is whether a recall would need to be submitted for issues involving missing information or label errors, even if there is no issue with the product itself. If the labels from our simulation were peeling… Read more»
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jaf22 replied to the topic "510(k) clearance vs. Postmarket Approval" – 4 years, 2 months ago
Posted by: @as934 My question is how far can you embellish how similar a new device is to a predicate device? What ethical responsibilities lie with the company when they take this risk? Given that fraudulent 510(k) notices are a… Read more»
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anvitha replied to the topic "Project Objectives" – 4 years, 6 months ago
Posted by: @as934 I am in agreement with the other posts above that projects need to meet all three objectives in order to be considered successful. A project can never be successful if it is not achievable, a project that… Read more»