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Dani replied to the topic "Designing effective Communication management Plan" – 2 years, 12 months ago
Posted by: @smitshah Is it better to design communication management plan just once for all the project in the company and documenting it as a SOP or is it better to have a communication plan that is specific to a… Read more»
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anthonynjit replied to the topic "Double Blind Vs Single blind Study" – 3 years, 5 months ago
Posted by: @smitshah I cant really think Why is it needed to use double blind study since I think single blind i.e. only patient blind must work.In double blind both Investigator and patient will not know about the drug and… Read more»
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mmd55 replied to the topic "Fuzz before launch of product." – 3 years, 6 months ago
Posted by: @smitshah Especially in medical device companies when product are in developing stages how can a company like verb or ethicon which are working on new technology or are about to launch a new surgical robot how would the… Read more»
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rajamharrison replied to the topic "Double Blind Vs Single blind Study" – 3 years, 6 months ago
Posted by: @smitshah I cant really think Why is it needed to use double blind study since I think single blind i.e. only patient blind must work.In double blind both Investigator and patient will not know about the drug and… Read more»
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mejefferson replied to the topic "Double Blind Vs Single blind Study" – 3 years, 6 months ago
Posted by: @smitshah I cant really think Why is it needed to use double blind study since I think single blind i.e. only patient blind must work.In double blind both Investigator and patient will not know about the drug and… Read more»
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tlstrickland replied to the topic "Research for the Fututre or Now?" – 3 years, 9 months ago
Posted by: @smitshah Research in advancement and exploration of the unknowns in the wild. There is no definitive path if in the path we have a urge to know there are thing for which we can’t give any reason for… Read more»
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k-faulk replied to the topic "Designing effective Communication management Plan" – 3 years, 11 months ago
Posted by: @smitshah Is it better to design communication management plan just once for all the project in the company and documenting it as a SOP or is it better to have a communication plan that is specific to a… Read more»
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ashabazz replied to the topic "Things to look for in a contract while selecting a supplier" – 3 years, 11 months ago
Posted by: @smitshah When you have to supplier both having good reputation for the things they manufacture and supply but only thing that can distinguish them is the contract they presented. So which factors would you consider to look for… Read more»
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djwhitemsm-edu replied to the topic "Things to look for in a contract while selecting a supplier" – 3 years, 11 months ago
Posted by: @smitshah When you have to supplier both having good reputation for the things they manufacture and supply but only thing that can distinguish them is the contract they presented. So which factors would you consider to look for… Read more»
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maniakberk replied to the topic "Delay in Recall." – 4 years, 6 months ago
Posted by: @smitshah I was wondering that why are the recall either made by company or made my FDA are of items which have been in the market for at least 5-8 years after the launch in market. Why cant… Read more»
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maniakberk replied to the topic "Relation of Quality with other department." – 4 years, 6 months ago
Posted by: @smitshah From the lecture as we saw that major work of quality department is to oversee if all other department have abide to procedure which are set by regulatory boards in order to get certified and if a… Read more»
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JordanKayal replied to the topic "Inputs for Design Input Document" – 5 years, 1 month ago
Posted by: @smitshah In Design input document marketing Team brings most of the specification for the device. What would be the most efficient way to brings this input and who else can help to bring in more specification so that… Read more»
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JordanKayal replied to the topic "Double Blind Vs Single blind Study" – 5 years, 5 months ago
Posted by: @smitshah I cant really think Why is it needed to use double blind study since I think single blind i.e. only patient blind must work.In double blind both Investigator and patient will not know about the drug and… Read more»
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JordanKayal replied to the topic "Double Blind Vs Single blind Study" – 5 years, 5 months ago
Posted by: @smitshah I cant really think Why is it needed to use double blind study since I think single blind i.e. only patient blind must work.In double blind both Investigator and patient will not know about the drug and… Read more»
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JordanKayal replied to the topic "Relation of Quality with other department." – 5 years, 6 months ago
Posted by: @smitshah From the lecture as we saw that major work of quality department is to oversee if all other department have abide to procedure which are set by regulatory boards in order to get certified and if a… Read more»
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JordanKayal replied to the topic "Delay in Recall." – 5 years, 6 months ago
Posted by: @smitshah I was wondering that why are the recall either made by company or made my FDA are of items which have been in the market for at least 5-8 years after the launch in market. Why cant… Read more»
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thuytienlecao replied to the topic What is Risk-benefit analysis ? in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
I would like elaborate @merzkrashed‘s point about the FDA article “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”.
When determining risk, the FDA assessing the severity, type, frequency, and length of harmful events. In addition, the FDA will also evaluate other…[Read more]
