Medical Device Courses | smitshah | Mentions https://medicaldevicecourses.com/members/smitshah/activity/mentions/ Activity feed mentioning smitshah. Sat, 25 Apr 2026 02:46:49 -0400 https://buddypress.org/?v= en-US 30 hourly 2 32ba66b3f86e0f2e7696f8fa8dab20cb Dani replied to the topic "Designing effective Communication management Plan" - https://medicaldevicecourses.com/activity/p/25576/ Tue, 12 Apr 2022 23:51:36 -0400 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»

]]> 5db5e599382555918d84481e735887eb anthonynjit replied to the topic "Double Blind Vs Single blind Study" - https://medicaldevicecourses.com/activity/p/23795/ Tue, 19 Oct 2021 20:51:17 -0400 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»

]]> 033029ac964cb14235d652058d9c9476 mmd55 replied to the topic "Fuzz before launch of product." - https://medicaldevicecourses.com/activity/p/23705/ Tue, 12 Oct 2021 22:14:45 -0400 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»

]]> 1ea31bfd32aeb42f31e6edf68d6f7b42 rajamharrison replied to the topic "Double Blind Vs Single blind Study" - https://medicaldevicecourses.com/activity/p/23460/ Sat, 25 Sep 2021 15:42:55 -0400 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»

]]> f4ec2db3097271281e9345b49f13a995 mejefferson replied to the topic "Double Blind Vs Single blind Study" - https://medicaldevicecourses.com/activity/p/23395/ Sun, 19 Sep 2021 23:16:38 -0400 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»

]]> 032b6412cbe09a94f755f96c395b608d tlstrickland replied to the topic "Research for the Fututre or Now?" - https://medicaldevicecourses.com/activity/p/22848/ Wed, 30 Jun 2021 18:30:33 -0400 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»

]]> db7bffacb75a0f984e109b418be614c6 k-faulk replied to the topic "Designing effective Communication management Plan" - https://medicaldevicecourses.com/activity/p/22285/ Sun, 25 Apr 2021 16:47:52 -0400 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»

]]> 07004b58708b10f6fc4e95c465aea312 ashabazz replied to the topic "Things to look for in a contract while selecting a supplier" - https://medicaldevicecourses.com/activity/p/22282/ Sun, 25 Apr 2021 16:31:04 -0400 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»

]]> 9c6c2504db1d99962b7295e9290de0f5 djwhitemsm-edu replied to the topic "Things to look for in a contract while selecting a supplier" - https://medicaldevicecourses.com/activity/p/22206/ Mon, 19 Apr 2021 19:10:51 -0400 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»

]]> 69c7e989c83f2894f5fce23b35583419 maniakberk replied to the topic "Delay in Recall." - https://medicaldevicecourses.com/activity/p/20480/ Mon, 28 Sep 2020 03:26:27 -0400 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»

]]> 9bfb817e8ef1ad0c7328406cf3af50ee maniakberk replied to the topic "Relation of Quality with other department." - https://medicaldevicecourses.com/activity/p/20473/ Mon, 28 Sep 2020 02:50:00 -0400 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»

]]> 3c1758a3e20c6090ef4f2dc1652532d3 JordanKayal replied to the topic "Inputs for Design Input Document" - https://medicaldevicecourses.com/activity/p/19529/ Thu, 20 Feb 2020 23:03:40 -0500 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»

]]> a3cea25060f0828223a3f8d2eb03e3a5 JordanKayal replied to the topic "Double Blind Vs Single blind Study" - https://medicaldevicecourses.com/activity/p/18917/ Sat, 26 Oct 2019 15:11:42 -0400 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»

]]> 497ac1bc1a3706a612d8ff95924728e2 JordanKayal replied to the topic "Double Blind Vs Single blind Study" - https://medicaldevicecourses.com/activity/p/18916/ Sat, 26 Oct 2019 15:10:49 -0400 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»

]]> 571fdf6a986eb91da08655bfdf6e3daf JordanKayal replied to the topic "Relation of Quality with other department." - https://medicaldevicecourses.com/activity/p/18720/ Sat, 05 Oct 2019 15:47:28 -0400 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»

]]> e4eb3732510a924067fee762e9a7d9f4 JordanKayal replied to the topic "Delay in Recall." - https://medicaldevicecourses.com/activity/p/18644/ Fri, 27 Sep 2019 01:43:56 -0400 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»

]]> 43004411a101158b38baffe70722517a thuytienlecao replied to the topic What is Risk-benefit analysis ? in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5128/ Fri, 17 Nov 2017 14:51:36 -0500 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]

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