Medical Device Courses | kdg4 | Activity https://medicaldevicecourses.com/members/kdg4/activity/ Activity feed for kdg4. Sat, 16 May 2026 07:36:00 -0400 https://buddypress.org/?v= en-US 30 hourly 2 9b9fed3eafad73a9068d11749cd0fbbb kdg4 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/11443/ Wed, 15 May 2019 16:45:01 -0400 Both written and verbal can be very useful, but I would think that a verbal agreement should be followed up with a written agreement. A verbal can be good to work out the terms, but once on paper those terms…   Read more»

]]> 74ec767d4d7ab887ef8784db48af15c1 kdg4 replied to the topic "Recent Examples of Kickback Allegations" - https://medicaldevicecourses.com/activity/p/11441/ Wed, 15 May 2019 16:45:00 -0400 In terms of kickbacks, maybe a lot of these happen because some people may not think it is a big deal to accept to those things. Maybe it is just thought of as the cost of doing business in the…   Read more»

]]> eebcaba573a54f4b5a3e05a70f323955 kdg4 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11327/ Wed, 15 May 2019 16:43:57 -0400 This course has been very useful to show people what could really be expected of them when they get into the real world. It was good to see the different stages of developing a medical device, and what is expected…   Read more»

]]> a66dc6a6448669ae68d35fad1c2e4e97 kdg4 replied to the topic "Organization types of medical devices?" - https://medicaldevicecourses.com/activity/p/11233/ Wed, 15 May 2019 16:43:10 -0400 The idea of the matrix organization seems to be a great idea for forming a project team. It will give the project manager an opportunity to really pick those people who may be best for that particular project. Sometimes people…   Read more»

]]> 1c31cc0ea026e101561f17e0c32c5a4b kdg4 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/11232/ Wed, 15 May 2019 16:43:10 -0400 When working with people you may not know, that could be a good thing to allow for different ideas to come about. If you are not used to working with a certain person it may take some time to develop…   Read more»

]]> 5cd11263cb5b25da67f2e98b44ec1c98 kdg4 replied to the topic "Project Management Preferences" - https://medicaldevicecourses.com/activity/p/11231/ Wed, 15 May 2019 16:43:09 -0400 The hardest part of a matrix based organization would seem to be getting people to be on their project team. If a person if involved in other projects it may be hard to coordinate with that person to get them…   Read more»

]]> 2a3193802e9e5e571157e3b19c8abe23 kdg4 replied to the topic "Expense of Regulations" - https://medicaldevicecourses.com/activity/p/11101/ Wed, 15 May 2019 16:39:55 -0400 I understand that having to pay may just be the cost of doing business, but I do agree having a database would be helpful to those smaller companies. Some smaller companies may have such innovative ideas and be able to…   Read more»

]]> 40d44ab3867a7cbac2be44336f9fc8c9 kdg4 replied to the topic "Risk management methods" - https://medicaldevicecourses.com/activity/p/11100/ Wed, 15 May 2019 16:39:54 -0400 FMEA does sound interesting Roberto. By being able to make sure you device fails and then fixing those failures could be a way to have a stronger more reliable product. On the flip side, if you are unable to fix…   Read more»

]]> 968f43d8f04c0632552f63deb84b3a00 kdg4 replied to the topic "Risk analysis in real company" - https://medicaldevicecourses.com/activity/p/11099/ Wed, 15 May 2019 16:39:54 -0400 A meeting to determine if a project is a go or no go seems to rely heavily on the risk management. It seems like a good idea to have multiple departments involved in this process to fully identify the risks…   Read more»

]]> 81e4df38219f127ee4e06a103646873c kdg4 replied to the topic "Design Transfer" - https://medicaldevicecourses.com/activity/p/10972/ Wed, 15 May 2019 16:38:26 -0400 When it comes to outsourcing, it seems that it can be a very hard process. The company wants to make sure their vendor is doing everything properly when they transfer it over. This would mean their is nothing left to…   Read more»

]]> e264e6d9dbab76143af9e73a398ff59c kdg4 replied to the topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/10971/ Wed, 15 May 2019 16:38:25 -0400 I unfortunately do not have industry experience in a design review, but I can imagine how these meetings impact the development of the project. During these meetings it must also be important to stay on top of the changes that…   Read more»

]]> 8fcc90dfbda3ecd38a4e7d101190d96f kdg4 replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/10969/ Wed, 15 May 2019 16:38:24 -0400 Meeting minutes are important to recap what was said or done in a meeting. I have been tasked with taking minutes, but I know that no one really read them. It would be just sent to the manager and uploaded…   Read more»

]]> c204e52c939e51684ab41adc43f3fa87 kdg4 replied to the topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/10831/ Wed, 15 May 2019 16:36:59 -0400 It seems that design controls can be ever changing with how the device is developed over time. Reading over the previous replies, it is true that companies can not change the design controls forever. If that were the case then…   Read more»

]]> 5bd55c0d13d0b2b7bfac52fdedc1574b kdg4 replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/10830/ Wed, 15 May 2019 16:36:58 -0400 A very important part of the DDP is the scope management plan. If the scope of the project is not clearly defined and kept in focus nothing will get done to move the project forward. Once people working on the…   Read more»

]]> 64eeedf02ee2e1cbb122088285d2e0d4 kdg4 replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/10829/ Wed, 15 May 2019 16:36:58 -0400 When the process is not used properly, it results in a failed medical device as stated by those examples above. In the case of those recalled medical devices, it would be interesting to know what their design controls were and…   Read more»

]]> 3808526c10070db427c2ac042972127e kdg4 replied to the topic "Discussion Topic: Is the DHF a living document?" - https://medicaldevicecourses.com/activity/p/10828/ Wed, 15 May 2019 16:36:58 -0400 In my opinion it seems that the DHF could be a combination of the two. There could be some things that do not change throughout the design process, and then there could be things that are updated. Considering how much…   Read more»

]]> 49aa26a37326e89511c858fce99f8e57 kdg4 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/945/ Mon, 05 Dec 2016 14:46:00 -0500 Both written and verbal can be very useful, but I would think that a verbal agreement should be followed up with a written agreement. A verbal can be good to work out the terms, but once on paper those terms are clear to both parties and it will be signed to show both agree. In the written you can capture everything that is needed, which may be…[Read more]

]]> 0 618c6bb2ad2fbcf1a54dbd80841b0755 kdg4 replied to the topic Recent Examples of Kickback Allegations in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/943/ Mon, 05 Dec 2016 14:38:05 -0500 In terms of kickbacks, maybe a lot of these happen because some people may not think it is a big deal to accept to those things. Maybe it is just thought of as the cost of doing business in the field, and that has almost become a norm. Since it has been happening for a long time, those people in the industry have just become desensitized and…[Read more]

]]> 0 5e742f1286ce93242d20d4c74c51179a kdg4 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/805/ Tue, 29 Nov 2016 15:05:48 -0500 This course has been very useful to show people what could really be expected of them when they get into the real world. It was good to see the different stages of developing a medical device, and what is expected in every step. Project management as a whole is something that can be useful to everyone even if they are specifically a project…[Read more]

]]> 0 bd7611c60e59564d7287c2b7d675e3f5 kdg4 replied to the topic Organization types of medical devices? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/695/ Thu, 24 Nov 2016 19:27:30 -0500 The idea of the matrix organization seems to be a great idea for forming a project team. It will give the project manager an opportunity to really pick those people who may be best for that particular project. Sometimes people may have a certain niche that will really benefit a project and if the project manager is able to capitalize on that, it…[Read more]

]]> 0 84338f9c09c6484652b7b1fdf95816cc kdg4 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/694/ Thu, 24 Nov 2016 19:23:47 -0500 When working with people you may not know, that could be a good thing to allow for different ideas to come about. If you are not used to working with a certain person it may take some time to develop a working relationship, but it could lead to some great ideas that would have not been thought of otherwise. When working with friends, that could…[Read more]

]]> 0 ab892f53b28317b293cd07c0bee29905 kdg4 replied to the topic Project Management Preferences in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/693/ Thu, 24 Nov 2016 19:17:56 -0500 The hardest part of a matrix based organization would seem to be getting people to be on their project team. If a person if involved in other projects it may be hard to coordinate with that person to get them involved in their project. It does seem like a way to fully utilize all of the resources available in the company without having to…[Read more]

]]> 0 2bcb2749bd2f016ce345ab6891569eec kdg4 replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/521/ Thu, 17 Nov 2016 19:24:00 -0500 I understand that having to pay may just be the cost of doing business, but I do agree having a database would be helpful to those smaller companies. Some smaller companies may have such innovative ideas and be able to really back that up with a product, but the cost of the purchasing these could really hinder that. If it were available in…[Read more]

]]> 0 3bf8ac5006333f969368d62be761b242 kdg4 replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/520/ Thu, 17 Nov 2016 19:15:48 -0500 FMEA does sound interesting Roberto. By being able to make sure you device fails and then fixing those failures could be a way to have a stronger more reliable product. On the flip side, if you are unable to fix those failures that could be a great indication that this project should be on the market. This seems like something could be useful in…[Read more]

]]> 0 d0dbb2cc4791c55459c38a5158636a97 kdg4 replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/519/ Thu, 17 Nov 2016 19:07:49 -0500 A meeting to determine if a project is a go or no go seems to rely heavily on the risk management. It seems like a good idea to have multiple departments involved in this process to fully identify the risks associated with the project. Risk in pharma is certainly different than risk in a medical device company. Risk in pharma could be activating…[Read more]

]]> 0 0b1dad2810157c454f06da17b24635fc kdg4 replied to the topic Design Transfer in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/350/ Fri, 11 Nov 2016 13:57:03 -0500 When it comes to outsourcing, it seems that it can be a very hard process. The company wants to make sure their vendor is doing everything properly when they transfer it over. This would mean their is nothing left to chance anymore and the company has made sure their instructions are very clear to the vendor. In this case the vendor has to ensure…[Read more]

]]> 0 77ca6a7c7a95535d4ac8c8ce58a277ed kdg4 replied to the topic Design Review Meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/349/ Fri, 11 Nov 2016 13:50:12 -0500 I unfortunately do not have industry experience in a design review, but I can imagine how these meetings impact the development of the project. During these meetings it must also be important to stay on top of the changes that need to be made to the documents or else it may become overwhelming. Also, with some many different opinions, it may be…[Read more]

]]> 0 38f5a3bcb970172440cd7ce0809db7e4 kdg4 replied to the topic Minutes for meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/347/ Fri, 11 Nov 2016 13:43:22 -0500 Meeting minutes are important to recap what was said or done in a meeting. I have been tasked with taking minutes, but I know that no one really read them. It would be just sent to the manager and uploaded to SharePoint. Even though they were barely read they were a good tool to remember any action items that needed to be completed. It was good if…[Read more]

]]> 0 df9a3a05e1d42665c15482a3d1f7eb55 kdg4 replied to the topic What are Design Controls? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/144/ Fri, 04 Nov 2016 22:25:11 -0400 It seems that design controls can be ever changing with how the device is developed over time. Reading over the previous replies, it is true that companies can not change the design controls forever. If that were the case then they would never create an end product.There must be a point where they decide that the device is safe enough or the most…[Read more]

]]> 0 1461f16bfac1255ef7ee34137d42dc35 kdg4 replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/143/ Fri, 04 Nov 2016 22:01:38 -0400 A very important part of the DDP is the scope management plan. If the scope of the project is not clearly defined and kept in focus nothing will get done to move the project forward. Once people working on the project know exactly what is needed to get done they can begin to work on it. Once the scope is clearly defined in a scope management plan,…[Read more]

]]> 0 42e44f8b762fa759d79d3c8864c935a7 kdg4 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/142/ Fri, 04 Nov 2016 21:54:13 -0400 When the process is not used properly, it results in a failed medical device as stated by those examples above. In the case of those recalled medical devices, it would be interesting to know what their design controls were and if they passed. It would also be interesting to know what made those companies feel that their products was able to be put…[Read more]

]]> 0 90d9c243865f7507f707d8ec8d1f040e kdg4 replied to the topic Discussion Topic: Is the DHF a living document? in the forum The Design History File https://medicaldevicecourses.com/activity/p/141/ Fri, 04 Nov 2016 21:43:53 -0400 In my opinion it seems that the DHF could be a combination of the two. There could be some things that do not change throughout the design process, and then there could be things that are updated. Considering how much information the DHF holds, it seems unusual to limit its capabilities. Based on the lecture this week a DHF is supposed to contain…[Read more]

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