Medical Device Courses | kmt29 | Activity https://medicaldevicecourses.com/members/kmt29/activity/ Activity feed for kmt29. Sat, 25 Apr 2026 02:21:41 -0400 https://buddypress.org/?v= en-US 30 hourly 2 09bed06e36296d5eef335dc504b6a967 kmt29 replied to the topic "Restrictions for physician's gifts" - https://medicaldevicecourses.com/activity/p/11386/ Wed, 15 May 2019 16:44:29 -0400 Excellent question; I think it’s very restricted, but the whole process is wrong. Why do the physicians have to take his wife to the business meeting anyway? I agree with the second comment, there is no reason for a spouse…   Read more»

]]> bebaade17af50b8fcb19421e6811e6f7 kmt29 replied to the topic "Consultants NDAs and CDAs" - https://medicaldevicecourses.com/activity/p/11380/ Wed, 15 May 2019 16:44:25 -0400 Everyone is making valid points; I do not have any similar experience but I do think the scenario that you gave is very interesting. My input on this is that the company put themselves in a tough situation for hiring…   Read more»

]]> c8f422736f52176fca1a012a91c69145 kmt29 replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/11269/ Wed, 15 May 2019 16:43:29 -0400 I would like to work in a functional organization because it will be easier to work on the project with the people in your department. Even though it may have a disadvantage, I rather have one person make the final…   Read more»

]]> b9cf41234e2f420253884fc76d61e157 kmt29 replied to the topic "Organizational Behavior Management" - https://medicaldevicecourses.com/activity/p/11247/ Wed, 15 May 2019 16:43:18 -0400 The article you posted was very interesting. Currently at my job the organizational behavior is all over the place and it impacts the way we all operate. Learning about OBM made me realize that some companies lack that aspect and…   Read more»

]]> 836e3f2209af2b8d4ff701ab7dde835d kmt29 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/11246/ Wed, 15 May 2019 16:43:17 -0400 That is a tough question, but forming a great team is putting individuals together that are good at their roles, communication and other skills. I don’t think it’s sometimes good to put the people you have a good relationship with…   Read more»

]]> 64be5bfc9e51a76775140e649b5476f8 kmt29 replied to the topic "Risk management and Labels" - https://medicaldevicecourses.com/activity/p/11153/ Wed, 15 May 2019 16:40:21 -0400 But if the patient can not understand the residual risk that means FDA is allowing products to go on the market with risks not described clearly in the labels. What if the risk is high, but thats the only medication…   Read more»

]]> 740731f2b4acc4152dade4ae7762c90b kmt29 replied to the topic "Risk analysis in real company" - https://medicaldevicecourses.com/activity/p/11152/ Wed, 15 May 2019 16:40:21 -0400 I have no experience with risk analysis, but i think there is no major difference between the medical device and pharma world. After doing a little research I found a website/pdf that broke down the quality risk management process which…   Read more»

]]> 0064ee43834047749becc730c45d5cc8 kmt29 replied to the topic "Risk management and Labels" - https://medicaldevicecourses.com/activity/p/11146/ Wed, 15 May 2019 16:40:18 -0400 I do not think it is fair for companies do that to patients because they put them into so many health risk that are not safe especially if we look beyond painkillers. I think they should create seminars or tutorials…   Read more»

]]> e53f8b03fc32a12a6af04fc3ccae4ba3 kmt29 replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/11044/ Wed, 15 May 2019 16:39:21 -0400 That is a tough choice because all of those are very important to DDP! If I had to choose one it would be scope management plan; the reason behind that is that having a general scope of how I am…   Read more»

]]> a2271d6fcfe5cb22a2ee29d3fbe0d98f kmt29 replied to the topic "When is validation is not required?" - https://medicaldevicecourses.com/activity/p/11039/ Wed, 15 May 2019 16:39:17 -0400 I do believe that even if there are no changes after the verification the human factors evaluation is needed because it allows you to check the quality of the product. Also, the evaluation can show if the product can be…   Read more»

]]> d6bc0616f685a7560d7351bc96a4df0d kmt29 replied to the topic "Customer Needs, Business Requirements, Test Plan" - https://medicaldevicecourses.com/activity/p/11035/ Wed, 15 May 2019 16:39:16 -0400 I didn’t do my undergraduate at NJIT ,but I believe it’s common for a medical device to go through common steps. Those steps may just have a different name and ask for specific information. I think it’s good that they…   Read more»

]]> 1faee36c55560b252908a76503c05ef5 kmt29 replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/10904/ Wed, 15 May 2019 16:37:45 -0400 Design inputs are very broad because every indivdual that may be on the team has different ideas. An example could be : -how much life span will this product have? -who are our customers? -what are the safety factors? To…   Read more»

]]> 3019b2c948bec52954af18028df355ed kmt29 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" - https://medicaldevicecourses.com/activity/p/10902/ Wed, 15 May 2019 16:37:44 -0400 At first before reading the other comments I thought that design control was needed in the EU, but I saw that it is not mandated unlike the US. The pros in a DHF are that allows you to see the…   Read more»

]]> 3ce59dceeddafd1d9ef77f87d8223a2f kmt29 replied to the topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/10899/ Wed, 15 May 2019 16:37:42 -0400 Design controls are a set of methods used to complete/finish your design and it goes into more details are you all have already mention. The crazy thing is that all types of industries use design control in some sort,but may…   Read more»

]]> 9ddcf71e444f053e1d29798d60b3f949 kmt29 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/884/ Sun, 04 Dec 2016 17:35:10 -0500 Excellent question; I think it’s very restricted, but the whole process is wrong. Why do the physicians have to take his wife to the business meeting anyway? I agree with the second comment, there is no reason for a spouse or family member to in be in such meeting. I think it can cause problems in the long run in my opinion. The bribing that i…[Read more]

]]> 0 9d3085a6c109341d9702d259d174436f kmt29 replied to the topic Consultants NDAs and CDAs in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/878/ Sun, 04 Dec 2016 13:17:20 -0500 Everyone is making valid points; I do not have any similar experience but I do think the scenario that you gave is very interesting. My input on this is that the company put themselves in a tough situation for hiring someone who is using company documentation. I am wondering why the company didn’t ask for a template or conduct a background c…[Read more]

]]> 0 08333631dbeb5ab23de436933f1adf2d kmt29 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/739/ Sun, 27 Nov 2016 19:21:25 -0500 I would like to work in a functional organization because it will be easier to work on the project with the people in your department. Even though it may have a disadvantage, I rather have one person make the final decision; instead of so many people having to make one final decision. Currently I think I work in a matrix organization at my job…[Read more]

]]> 0 4df06531f357207b89eb583fefc48a44 kmt29 replied to the topic Organizational Behavior Management in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/710/ Sat, 26 Nov 2016 19:03:49 -0500 The article you posted was very interesting. Currently at my job the organizational behavior is all over the place and it impacts the way we all operate. Learning about OBM made me realize that some companies lack that aspect and tend to forget that it is an important piece. I also think it applies to all fields of work. The link below is another…[Read more]

]]> 0 84f70834bf71033dc9af69447a059dc5 kmt29 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/709/ Sat, 26 Nov 2016 18:45:36 -0500 That is a tough question, but forming a great team is putting individuals together that are good at their roles, communication and other skills. I don’t think it’s sometimes good to put the people you have a good relationship with because it could cost problems in the long run for the team. I would try to get someone new and fresh mix with exp…[Read more]

]]> 0 5f56c522ba297dece3879e18671a1d72 kmt29 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/708/ Sat, 26 Nov 2016 18:45:36 -0500 That is a tough question, but forming a great team is putting individuals together that are good at their roles, communication and other skills. I don’t think it’s sometimes good to put the people you have a good relationship with because it could cost problems in the long run for the team. I would try to get someone new and fresh mix with exp…[Read more]

]]> 0 2d382206146549a9a32d60e4e1f01867 kmt29 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/598/ Sun, 20 Nov 2016 23:47:44 -0500 But if the patient can not understand the residual risk that means FDA is allowing products to go on the market with risks not described clearly in the labels. What if the risk is high, but thats the only medication that works for a person then who is at risk now?

]]> 0 317c2abc343159de572651e2b4e710bb kmt29 replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/597/ Sun, 20 Nov 2016 23:44:52 -0500 I have no experience with risk analysis, but i think there is no major difference between the medical device and pharma world. After doing a little research I found a website/pdf that broke down the quality risk management process which is very similar to the medical device. Those steps are:
1) Risk assessment
2) Risk control
3) Risk…[Read more]

]]> 0 dba00ee9cc17e34fbf223785b58a02b3 kmt29 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/590/ Sun, 20 Nov 2016 22:10:32 -0500 I do not think it is fair for companies do that to patients because they put them into so many health risk that are not safe especially if we look beyond painkillers. I think they should create seminars or tutorials to inform patience the proper way to take the painkiller or product, so that way it could reduce the risk. Think about it for a…[Read more]

]]> 0 1c5de25a9d27bcad1ee01e2ad5713682 kmt29 replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/447/ Mon, 14 Nov 2016 04:42:16 -0500 That is a tough choice because all of those are very important to DDP! If I had to choose one it would be scope management plan; the reason behind that is that having a general scope of how I am going to execute my DDP it will make it a lot easier for me. Everyone is making some valid points! If there were four other major components that could be…[Read more]

]]> 0 886666a90ca9bd2165ed91a36063d0dd kmt29 replied to the topic When is validation is not required? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/441/ Mon, 14 Nov 2016 04:23:44 -0500 I do believe that even if there are no changes after the verification the human factors evaluation is needed because it allows you to check the quality of the product. Also, the evaluation can show if the product can be a good use to the human body. Just think about if there is no evaluation is not completed the device can be harmful for patients.…[Read more]

]]> 0 4c8d6198b4c8f82e236015b651c576e1 kmt29 replied to the topic Customer Needs, Business Requirements, Test Plan in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/437/ Mon, 14 Nov 2016 03:43:58 -0500 I didn’t do my undergraduate at NJIT ,but I believe it’s common for a medical device to go through common steps. Those steps may just have a different name and ask for specific information. I think it’s good that they require the students in that course to have to do a test plan document. It often seems as though we think a product has to be…[Read more]

]]> 0 4b0b633cd463090c73bae60289c6e95a kmt29 replied to the topic Design input sources in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/255/ Mon, 07 Nov 2016 02:59:10 -0500 Design inputs are very broad because every indivdual that may be on the team has different ideas.
An example could be :
-how much life span will this product have?
-who are our customers?
-what are the safety factors?
To me these are a few questions that I believe should be asked , because it makes an impact on the design concept and will help it…[Read more]

]]> 0 8bcce8b83308e85e1d739dd406b17ad8 kmt29 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/253/ Mon, 07 Nov 2016 02:54:04 -0500 At first before reading the other comments I thought that design control was needed in the EU, but I saw that it is not mandated unlike the US. The pros in a DHF are that allows you to see the growth and changes within the design process each step meaning the changes that may occur for at any instant; for example what if the raw material may need…[Read more]

]]> 0 31453b112c0f8a53afcbc5c53120f1cd kmt29 replied to the topic What are Design Controls? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/250/ Mon, 07 Nov 2016 02:34:53 -0500 Design controls are a set of methods used to complete/finish your design and it goes into more details are you all have already mention. The crazy thing is that all types of industries use design control in some sort,but may have a different name for it. According to the FDA design control is a major factor for medical devices manufacturers. I…[Read more]

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