https://medicaldevicecourses.com/members/au45/activity/ Activity feed for au45. Sat, 25 Apr 2026 01:24:17 -0400 https://buddypress.org/?v= en-US 30 hourly 2 1cfb4c92a1023c5dbd2910f6f410fa50 https://medicaldevicecourses.com/activity/p/11398/ Wed, 15 May 2019 16:44:35 -0400 If you are going to begin spending money and time on a project I would take the precautions of ensuring the agreement is written so if your funding decides to pull their resources or not collaborate with you for the…   Read more»

]]> a74812e88b9755e14ceb3963b39bdc01 https://medicaldevicecourses.com/activity/p/11396/ Wed, 15 May 2019 16:44:34 -0400 As an undergraduate student who is graduating next semester, I found this score extremely useful. This class was my first exposure to the field of industry. No other class has covered the different departments available within industry. At first glance…   Read more»

]]> 68d0d20433561060f6b17492df57bb68 https://medicaldevicecourses.com/activity/p/11292/ Wed, 15 May 2019 16:43:40 -0400 As Saad has mentioned I feel for most companies matrix based organization would be the most beneficial. I say this because your resources (employees) do not become redundant and the project manager can hand pick individuals from different departments within…   Read more»

]]> 21db6bddaf656b58459a4181b9e371ee https://medicaldevicecourses.com/activity/p/11251/ Wed, 15 May 2019 16:43:20 -0400 We can all agree that it would be ideal to have a knowledgeable team with a good relationship. However I feel as a project manager when picking a project team you must ensure your team members are qualified and knowledgeable…   Read more»

]]> 78adfb5d64494373943c0bae39ddc3cb https://medicaldevicecourses.com/activity/p/11250/ Wed, 15 May 2019 16:43:19 -0400 Both matrix and project based organizations have their advantages and disadvantages as a project manager. As a project manager I feel a significant factor in finding success is being able to create a harmonious work environment where everyone is on…   Read more»

]]> 380cbec0fc674060db73b03a0ab95af8 https://medicaldevicecourses.com/activity/p/11151/ Wed, 15 May 2019 16:40:20 -0400 I can understand where many of you in this discussion are coming from, however I am going to have to respectably disagree. Although it is the responsibility of the company to ensure that they have minimized the residual risk of…   Read more»

]]> 6e41b1594dbedc3bf204fcd8d1365f2e https://medicaldevicecourses.com/activity/p/11124/ Wed, 15 May 2019 16:40:06 -0400 At times it is very unlikely to be able to eliminate all risk in a medical device. The article posted above does a great job explaining what “as far as possible” implies in the IPO. This just ensures that the…   Read more»

]]> 397d70dd189f39a5703c0efb89773908 https://medicaldevicecourses.com/activity/p/11123/ Wed, 15 May 2019 16:40:06 -0400 For low severity risks you are either going use acceptance or mitigation. You are going to have to determine if the benefit is worth the risk. If the benefit is worth the severity of risk you are taking on you…   Read more»

]]> f9a80fac56e7c47330f4ab173ec3694f https://medicaldevicecourses.com/activity/p/11009/ Wed, 15 May 2019 16:39:00 -0400 There has been very good points made as to the benefits of large and small companies outsourcing for their design transfer into manufacturing process. I agree that small companies will often benefit from outsourcing the manufacturing process because often times…   Read more»

]]> 1a7240ac10576ace1088a7b6d3fb6074 https://medicaldevicecourses.com/activity/p/11008/ Wed, 15 May 2019 16:39:00 -0400 The verification and validation reports provide evidence for a company that their product inputs will directly lead to the product output. In order to confirm this is true you must design a test to validate the claims. These tests that…   Read more»

]]> 454a2ef764daa674f40c8f2653bfe630 https://medicaldevicecourses.com/activity/p/10992/ Wed, 15 May 2019 16:38:37 -0400 Although I have not yet been involved in a company meeting where meeting minutes were documented I can see why Dr. Simon has stressed the importance of the minutes in his lectures. These meeting minutes help document all vital information…   Read more»

]]> 8f2cd102aa68dd9ee08219b55356e2b3 https://medicaldevicecourses.com/activity/p/10884/ Wed, 15 May 2019 16:37:32 -0400 As our classmates have previously mentioned lapses in the design control benefit no one and are just dangerous for the consumers. As a company manufacturing and distributing novice medical devices coming in contact with human subjects must guarantee safety. If…   Read more»

]]> dcca9846d950d959b876a87b6754b0d5 https://medicaldevicecourses.com/activity/p/898/ Mon, 05 Dec 2016 00:02:12 -0500 If you are going to begin spending money and time on a project I would take the precautions of ensuring the agreement is written so if your funding decides to pull their resources or not collaborate with you for the project you have a written agreement show they must go through with the project. However if you are deciding a simple decision of…[Read more]

]]> 0 760312cab953d1b0ff9eff80b17ae752 https://medicaldevicecourses.com/activity/p/896/ Sun, 04 Dec 2016 23:50:05 -0500 As an undergraduate student who is graduating next semester, I found this score extremely useful. This class was my first exposure to the field of industry. No other class has covered the different departments available within industry. At first glance I assumed the class medical device development was going to be more about specific devices and…[Read more]

]]> 0 480dfff3336d9daaa8ef9663735ed8cf https://medicaldevicecourses.com/activity/p/763/ Mon, 28 Nov 2016 01:37:20 -0500 As Saad has mentioned I feel for most companies matrix based organization would be the most beneficial. I say this because your resources (employees) do not become redundant and the project manager can hand pick individuals from different departments within the company for the specific project that is at hand. This will allow for better…[Read more]

]]> 0 b1cca6432e91e2a423f6765d8c52d304 https://medicaldevicecourses.com/activity/p/718/ Sun, 27 Nov 2016 02:59:32 -0500 We can all agree that it would be ideal to have a knowledgeable team with a good relationship. However I feel as a project manager when picking a project team you must ensure your team members are qualified and knowledgeable before factoring in how they are going to get along. Although working in a team with a good relationship can help create a…[Read more]

]]> 0 d38ade095712223b40dc41ed99b65230 https://medicaldevicecourses.com/activity/p/717/ Sun, 27 Nov 2016 02:59:32 -0500 We can all agree that it would be ideal to have a knowledgeable team with a good relationship. However I feel as a project manager when picking a project team you must ensure your team members are qualified and knowledgeable before factoring in how they are going to get along. Although working in a team that has a good relationship with each other…[Read more]

]]> 0 fb531b0d007a2186b938239ed72fd917 https://medicaldevicecourses.com/activity/p/716/ Sun, 27 Nov 2016 02:59:32 -0500 We can all agree that it would be ideal to have a team with a good relationship and knowledgeable. However I feel as a project manager when picking a project team you must ensure your team members are qualified and knowledgeable before factoring in how they are going to get along. Although working in a team that has a good relationship with each…[Read more]

]]> 0 5980289231759c434cc4a09f97fd5dcb https://medicaldevicecourses.com/activity/p/715/ Sun, 27 Nov 2016 02:41:36 -0500 Both matrix and project based organizations have their advantages and disadvantages as a project manager. As a project manager I feel a significant factor in finding success is being able to create a harmonious work environment where everyone is on the same page. It is easier for the project manager to create this environment when working in a…[Read more]

]]> 0 4b177a48e9dee0072bb19b72c4fdd33a https://medicaldevicecourses.com/activity/p/596/ Sun, 20 Nov 2016 23:20:48 -0500 I can understand where many of you in this discussion are coming from, however I am going to have to respectably disagree. Although it is the responsibility of the company to ensure that they have minimized the residual risk of their product as far as possible, it is the patient’s responsibility to understand the residual risk of the product they…[Read more]

]]> 0 160186eaa2252ac2c13a8de8fa8d8c53 https://medicaldevicecourses.com/activity/p/562/ Sun, 20 Nov 2016 05:29:54 -0500 At times it is very unlikely to be able to eliminate all risk in a medical device. The article posted above does a great job explaining what “as far as possible” implies in the IPO. This just ensures that the cost to reduce the risk has absolutely no influence whether the risk is considered acceptable or not. Without this companies would try and…[Read more]

]]> 0 353776b8aa5e3beabd3977c76496b39c https://medicaldevicecourses.com/activity/p/561/ Sun, 20 Nov 2016 05:09:43 -0500 For low severity risks you are either going use acceptance or mitigation. You are going to have to determine if the benefit is worth the risk. If the benefit is worth the severity of risk you are taking on you can accept the risk and go on with our product. If the benefit is not significant enough for the risk you are going to have to mitigate…[Read more]

]]> 0 34e20359f49035223460da75f3dbfb76 https://medicaldevicecourses.com/activity/p/408/ Sun, 13 Nov 2016 23:19:10 -0500 There has been very good points made as to the benefits of large and small companies outsourcing for their design transfer into manufacturing process. I agree that small companies will often benefit from outsourcing the manufacturing process because often times they will not have the sufficient equipment available to manufacture their product…[Read more]

]]> 0 a78683a4d1c8af88bdf26f1d93f30eea https://medicaldevicecourses.com/activity/p/407/ Sun, 13 Nov 2016 23:19:10 -0500 There has been very good points made as to the benefits of large and small companies outsourcing for their design transfer into manufacturing process. I agree that small companies will often benefit from outsourcing the manufacturing process because often times they will not have the sufficient equipment available to manufacture their product…[Read more]

]]> 0 caa07d4baf8c3ed82ae0e30a92f53bec https://medicaldevicecourses.com/activity/p/406/ Sun, 13 Nov 2016 22:58:32 -0500 The verification and validation reports provide evidence for a company that their product inputs will directly lead to the product output. In order to confirm this is true you must design a test to validate the claims. These tests that Dr. Simon mentioned are going to differ according to different projects. As our classmates have discovered…[Read more]

]]> 0 13759e6e8d89904a2c82307fb3e62d85 https://medicaldevicecourses.com/activity/p/380/ Sun, 13 Nov 2016 03:15:54 -0500 Although I have not yet been involved in a company meeting where meeting minutes were documented I can see why Dr. Simon has stressed the importance of the minutes in his lectures. These meeting minutes help document all vital information obtained from the meeting and can act as evidence for your role in the project if there is any issues with…[Read more]

]]> 0 888bfc2d810d4e93ce59fca0ab6e5086 https://medicaldevicecourses.com/activity/p/231/ Mon, 07 Nov 2016 01:39:36 -0500 As our classmates have previously mentioned lapses in the design control benefit no one and are just dangerous for the consumers. As a company manufacturing and distributing novice medical devices coming in contact with human subjects must guarantee safety. If companies start taking lapses in their design controls it is going to decrease the…[Read more]

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