https://medicaldevicecourses.com/members/as934/activity/mentions/ Activity feed mentioning as934. Fri, 24 Apr 2026 21:48:21 -0400 https://buddypress.org/?v= en-US 30 hourly 2 7c74fb6f5351257af49d1beeb96ecb22 https://medicaldevicecourses.com/activity/p/29800/ Sat, 12 Oct 2024 23:24:22 -0400 @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»

]]> 23c6b73954cba459d8ce5ca8505716da https://medicaldevicecourses.com/activity/p/22772/ Fri, 25 Jun 2021 02:27:56 -0400 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»

]]> 57bc4abf104471dc4439637e019f37b0 https://medicaldevicecourses.com/activity/p/22574/ Mon, 31 May 2021 02:34:13 -0400 @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»

]]> a47f493ccb2e308980b21cbf4f0b0815 https://medicaldevicecourses.com/activity/p/22284/ Sun, 25 Apr 2021 16:42:49 -0400 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»

]]> 89df12fac18ea23d8c523366e2dbed93 https://medicaldevicecourses.com/activity/p/21846/ Tue, 23 Mar 2021 01:49:00 -0400 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»

]]> f7819193f4bb47b17670b399f2649e01 https://medicaldevicecourses.com/activity/p/21578/ Mon, 08 Mar 2021 03:38:07 -0500 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»

]]> 4fd03f1144b4361ac7dd34cb22e0aa04 https://medicaldevicecourses.com/activity/p/21291/ Sun, 07 Feb 2021 21:06:16 -0500 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»

]]> 23256aa88ae6163858fbe4937cc157d1 https://medicaldevicecourses.com/activity/p/21253/ Mon, 01 Feb 2021 14:00:02 -0500 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»

]]> c2d159932a2fe24337896b2bfa641de1 https://medicaldevicecourses.com/activity/p/20248/ Fri, 11 Sep 2020 12:24:09 -0400 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»

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