https://medicaldevicecourses.com/members/jlw23/activity/ Activity feed for jlw23. Sat, 25 Apr 2026 04:09:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 4bab71a338e16fcc396be94f73b4cdc4 https://medicaldevicecourses.com/activity/p/15934/ Wed, 15 May 2019 19:15:23 -0400 I also agree the motivation the project manager has, can be effected into the other members. And I think its important for the project manager to know that the outcome of the project should be constantly made aware to the…   Read more»

]]> e60a60ca888b9cc9a2933df2557842c2 https://medicaldevicecourses.com/activity/p/15932/ Wed, 15 May 2019 19:15:22 -0400 There is always a benefit to retaining talent. Experience employees are very important to the furtherance of any company. This is where star player and people of ordinary characters can come in and make a difference. However, it starts being…   Read more»

]]> 099f0c84ed4c1e175adf953330e8b90e https://medicaldevicecourses.com/activity/p/15927/ Wed, 15 May 2019 19:15:20 -0400 Personally, I feel like if people don’t work just to make a living at a comfortable position then they are seeking some way to leverage their skills and advance them by becoming more knowledgeable and versatile. Many people end up…   Read more»

]]> 7b331f2019f7b5bc0c7d189da9f4b18b https://medicaldevicecourses.com/activity/p/15782/ Wed, 15 May 2019 19:13:50 -0400 I think that there should be a communication plan documentation that is kind of generic like an SOP, however depending on the structure of the company this may not always work. If the company is one which departments have their…   Read more»

]]> 231a1aa123f795ccd6f43a66c719e4c6 https://medicaldevicecourses.com/activity/p/15781/ Wed, 15 May 2019 19:13:49 -0400 I think this is extremely important because the most important element of any project or system, is the human element. By insuring that the more suitable person for the job is selected can result in the product being nurtured in…   Read more»

]]> dd4d8efffee074803da31b7387ad2fff https://medicaldevicecourses.com/activity/p/15773/ Wed, 15 May 2019 19:13:45 -0400 I also agree that the contract should clearly say all the needs to be said about eh expectation of the interaction between the vendor and your company. Especially changes that they may make to the design of your procurement. For…   Read more»

]]> 0c41a725a31a8290d36966ff1269cfff https://medicaldevicecourses.com/activity/p/15572/ Wed, 15 May 2019 19:07:47 -0400 In the control phase any financial values can change based on the project dynamics. Usually the cost can be seen in the phase before the control phase and after where resources are established and assigned to a specific need. However,…   Read more»

]]> ecdf90bf35c7b4625eb1b6bf82fac645 https://medicaldevicecourses.com/activity/p/15571/ Wed, 15 May 2019 19:07:46 -0400 There are usually CAPA that are open to address these failures that are managed by the department head and the quality system. If there are failures with regulatory there is not must that can be done except to deal with…   Read more»

]]> 9256ffc7eee161e407ade24c387b6348 https://medicaldevicecourses.com/activity/p/15423/ Wed, 15 May 2019 19:06:09 -0400 When keeping up with milestones, one of our greatest tool is communication. We made sure we always gave updates on our every part of the project to the project manager to always make predictions on whether or not we would…   Read more»

]]> d5f36b71558b6b7ee4387ce2b9e382a0 https://medicaldevicecourses.com/activity/p/15417/ Wed, 15 May 2019 19:06:05 -0400 The validation check is a design step that insure that the input meets the user intent, if it does not then the design is incomplete or simply something else. I think that depending on the limitation that is preventing the…   Read more»

]]> 023cb244ac771ebdae05ba81d04a29c8 https://medicaldevicecourses.com/activity/p/15415/ Wed, 15 May 2019 19:06:04 -0400 The work that the team would have to do should be design with contingencies in the event of a member suddenly not being present. Some of the things I have seen in y experience is have very open dialog in…   Read more»

]]> a0ab6d40e1dc0fbc65036b7faa802316 https://medicaldevicecourses.com/activity/p/15249/ Wed, 15 May 2019 19:04:25 -0400 I definitely agree that the planning phase would have to be revisited and redone. All the factors that are essential to the packaging line must be evaluated and it’s economic needs must be known. In my experience if the budget…   Read more»

]]> 8c8944055e8b29e55ed1ca00534dac00 https://medicaldevicecourses.com/activity/p/15248/ Wed, 15 May 2019 19:04:24 -0400 I have experienced this quiet a few times as I work closely with PM’s. So anytime there is a change in a PM, due to any reason either the PM leaving or a senior PM taking over the project, there…   Read more»

]]> 09b4e8b7e7bf701dd9f472eaf5d0e41e https://medicaldevicecourses.com/activity/p/15246/ Wed, 15 May 2019 19:04:23 -0400 I have worked on a project where we had to design a system where we had to have all our lab equipment backed up to a encrypted server. Some of our challenges were the risks that came with having different…   Read more»

]]> bf38ffa04d8d90c5eb3e2985cb44138d https://medicaldevicecourses.com/activity/p/15063/ Wed, 15 May 2019 19:02:43 -0400 I am part of out weekly design control meeting for our company’s new product, we have a meeting where we discuss how we can improve the batch records and we assign task based on a tracker that we constantly update….   Read more»

]]> 081f9888450c8a6afce2ef10ec9d0fb4 https://medicaldevicecourses.com/activity/p/15060/ Wed, 15 May 2019 19:02:41 -0400 I have not even had to identify risk perspective from that large a range before, but I have seen different perspective about risk in my team. I worked on a project where the team leader main concern was the qualification…   Read more»

]]> 7ff8921a2015ace8354c21196ee2ecbb https://medicaldevicecourses.com/activity/p/15058/ Wed, 15 May 2019 19:02:40 -0400 I worked on a project where we had to collaborate with a different company or our validation projects. Because I was more familiar with the system and they were basically adding to our current system I basically came up with…   Read more»

]]> db518f28b960f603976184dd05eb0219 https://medicaldevicecourses.com/activity/p/14952/ Wed, 15 May 2019 19:01:41 -0400 I currently work in the pharmaceutical industry, most of the projects I work on was around building up our current labs to GMP standards. However, I had work of several different project with different department to do so with a…   Read more»

]]> 791273b91d86675372bf492749e4d17d https://medicaldevicecourses.com/activity/p/14909/ Wed, 15 May 2019 19:01:17 -0400 I also agree that the culture of the group is very important. It can get off to a rough start if the initial team is not very compatible . This is especially true when the project is ongoing or will…   Read more»

]]> 4b5960a56a89dbad5c622cef778f5514 https://medicaldevicecourses.com/activity/p/14740/ Wed, 15 May 2019 18:59:39 -0400 In the event that you are modifying a device to the point where you may need to have software modification, it will need validation. If it is a modification that do not need animal testing but may still require a…   Read more»

]]> b3257ed9baaef6e64fe52cf26ee92efb https://medicaldevicecourses.com/activity/p/14738/ Wed, 15 May 2019 18:59:38 -0400 In worked on a med-device for soft bone injuries that that I built with a group of 4 people. The design was based on a modification to a cam walker boot. The design was already similar in physical trails to…   Read more»

]]> 443fa0076a09f865f2138992bcf62cdd https://medicaldevicecourses.com/activity/p/14488/ Wed, 15 May 2019 18:57:23 -0400 Intellectual property is one of the most important things to consider protecting when making an agreement. The contract should consider the benefit and risk of both parties and should be very clear in spelling this out. I think that all…   Read more»

]]> bd00d1456322a56df9fbab3c80ba8f37 https://medicaldevicecourses.com/activity/p/14297/ Wed, 15 May 2019 18:54:53 -0400 I think the matrix organization is best simply because the advantages are centered around multiple control. There always a second opinion. Thought that can be difficulty to deal with sometime and may cause delays, it gives a higher degree to…   Read more»

]]> 3156deee797eaf71da34f33fa5af8a3c https://medicaldevicecourses.com/activity/p/14296/ Wed, 15 May 2019 18:54:53 -0400 I would not form a team based just on personal relationship. I would form a team based of the individual that best understand the objective of the project. Most people in industry can adjust themselves if the understand the project….   Read more»

]]> 57160b3d904274792ce94173a71366d8 https://medicaldevicecourses.com/activity/p/14295/ Wed, 15 May 2019 18:54:52 -0400 When working on projects where other companies are involved. I think that the most efficient type of organization is the functional or matrix organizations. I think that is important simply because every individual is representing the entire company, and company…   Read more»

]]> ee7239ca168e55095f6ac6ec64c560a9 https://medicaldevicecourses.com/activity/p/14197/ Wed, 15 May 2019 18:52:57 -0400 There are many ways risk are identified and dealt with in a company. In every department there are different risk factors that are considered for different perspective and that are sometimes only applicable to their department. In my experience risk…   Read more»

]]> b52b8c59a0886a16302fadfe9a1ddcbb https://medicaldevicecourses.com/activity/p/14189/ Wed, 15 May 2019 18:52:53 -0400 I think that avoidance is of the lowest severity simply because the problem is not his, however depending on the drawback to that product function it can be a difficult decision to make. I think that the highest severity would…   Read more»

]]> ad0ed8e9ae893531f79ff9abf1aa4e7d https://medicaldevicecourses.com/activity/p/14187/ Wed, 15 May 2019 18:52:52 -0400 I think that is anything in industry can easily lose its real purpose in the face of company agenda. Risk management should exist to insure that the used is completely safe and hot harmed at all by the device. However,…   Read more»

]]> 5574689419d7cdcd8b08d6dafd03e776 https://medicaldevicecourses.com/activity/p/13798/ Wed, 15 May 2019 17:08:18 -0400 I believe that meeting minutes are extremely important, even so that there is a person at my job that would take notes during the meeting and then type it up afterwards and send it to everyone. I have seen in…   Read more»

]]> 0346c12bdc4fcf12e845a1a0ea0662aa https://medicaldevicecourses.com/activity/p/13797/ Wed, 15 May 2019 17:08:18 -0400 In agree that the FDA may be more interested in insuring that the design controls for a specific device is within the FDA standards. For example, when a company send in a new IND to the FDA for a new…   Read more»

]]> 8896ceaa90c9404ad9f2f6618b1cd4de https://medicaldevicecourses.com/activity/p/13796/ Wed, 15 May 2019 17:08:17 -0400 There are design controls in most countries that design and manufacture medical devices. There are all specific to their particular country and must follow the standards given by that particular country. However, that are many med-devices that can be found…   Read more»

]]> 35f68ec9e4bdbab7e0f7d0e220119c37 https://medicaldevicecourses.com/activity/p/13563/ Wed, 15 May 2019 17:06:05 -0400 One approach that I have seen companies marketing their product is through partnerships with larger more recognized companies. This allows for the product to be seen by people who may already follow the growth of that larger company. In development…   Read more»

]]> 1d839aa423d7086b368692e1f7eae05e https://medicaldevicecourses.com/activity/p/13562/ Wed, 15 May 2019 17:06:05 -0400 In the industry there are indeed many products that can be discovered based on project needs. The Rees system is a product that is leaned about just by googling what is needed for monitoring equipment in validation programs, and the…   Read more»

]]> 7b33ffa57c5210272db3b6ef32de8a83 https://medicaldevicecourses.com/activity/p/13483/ Wed, 15 May 2019 17:05:16 -0400 There are a lot of interesting points made above which made it hard to make a decision. But from my research I would go with an LLC. As a mid sized company you can start as an LLC and change…   Read more»

]]> c899ced7811341cef9b18ca4a8c24e11 https://medicaldevicecourses.com/activity/p/13473/ Wed, 15 May 2019 17:05:11 -0400 Going through all the posts in this tread I agree with the majority of what everyone is saying- that I would not turn down a position based on the type of company. I would focus on the role and the…   Read more»

]]> e21ea8c98f651aaf7e2ffdcfaf1298a1 https://medicaldevicecourses.com/activity/p/13471/ Wed, 15 May 2019 17:05:10 -0400 Public companies have shares that can be publicly traded in the stock market. Private companies do not have stock that can be publicly traded. One of the advantages of a private company is that Private companies are not required to…   Read more»

]]> b61585d6de6b8a92815c476347d26f95 https://medicaldevicecourses.com/activity/p/13355/ Wed, 15 May 2019 17:04:14 -0400 I think that inmost departments that are impacted by quality there is usually not enough focus on the big picture. In most departments the main focus are the goals of the particular department. While the quality department would focus on…   Read more»

]]> 4befc03b4f8a4e208b1ed7ce7b3e3fbd https://medicaldevicecourses.com/activity/p/13329/ Wed, 15 May 2019 17:03:56 -0400 I currently work in manufacturing and everything we do is review by Quality. Our department has a good relationship with QA who reviews our batch records. This may just be so due to the fact that manufacturing doesn’t really get…   Read more»

]]> 9ed24bfadd9c59e9804b4afdc41718d3 https://medicaldevicecourses.com/activity/p/13200/ Wed, 15 May 2019 17:02:50 -0400 The article I looked at stated that the IOM report on the 510(k) process contains broad recommendations that may have significant consequences and impacts on the medical device industry. Specifically, IOM concluded that the 510(k) process “cannot be transformed into…   Read more»

]]> 059ae2c7ec6b77287764ad79cbf94af8 https://medicaldevicecourses.com/activity/p/13178/ Wed, 15 May 2019 17:02:38 -0400 I read an article about some rumors that Apple is trying to come up with a watch that continuously measures the blood glucose level. In the early 2000s, the FDA approved a device called the GlucoWatch. It used a low…   Read more»

]]> f12e7f9c374a881ba46d57f4ee21161f https://medicaldevicecourses.com/activity/p/13177/ Wed, 15 May 2019 17:02:38 -0400 Based on my research, the FDA started regulating tobacco in 2009 by the passage of the Family Smoking Prevention and Tobacco Control Act. What I found interesting is that the Family Smoking Prevention and Tobacco Control Act specifically states that…   Read more»

]]> b4a87d7ed6b534fc943169152a9026dc https://medicaldevicecourses.com/activity/p/13023/ Wed, 15 May 2019 17:01:19 -0400 I do not have any personal experience working with a company where the study itself was outsourced but I do have experience seeing a vital part of the company being outsourced. At my first job the Help desk was outsourced…   Read more»

]]> 43dc6907ffca47985f888bd90575f3cf https://medicaldevicecourses.com/activity/p/13019/ Wed, 15 May 2019 17:01:17 -0400 In the Industry research has a shorter time limit as there is time ticking and there is much more pressure on making it work as it has to be sold and make money otherwise the company is at a loss….   Read more»

]]> d95bbb4de26cfd4a254f30eb7fb5f0c6 https://medicaldevicecourses.com/activity/p/13014/ Wed, 15 May 2019 17:01:15 -0400 As mention, for testing in biocompatibility, the testing should follow ISO 10993. However, depending on the product there are various other testing that needs to be done before the procurement of any material that goes into a process and after…   Read more»

]]> f104f45b835ad70364143afe59eb2e99 https://medicaldevicecourses.com/activity/p/13012/ Wed, 15 May 2019 17:01:14 -0400 I had worked in a research lab on TBI when we used a blast tube to collect data on pressure being applied to the brain. One of the issues that we experienced was the amount of pressure that were actually…   Read more»

]]> e91148ad02580bd67fdb9e53000f8dbf https://medicaldevicecourses.com/activity/p/12889/ Wed, 15 May 2019 17:00:00 -0400 The projects that is have worked on, the milestones were the body of the project. I think that missing milestones can result in failure of the project. At least in the projects that I have worked on all the milestones…   Read more»

]]> 375799a9b0e9bcccf1fa6cd86058fb3d https://medicaldevicecourses.com/activity/p/12888/ Wed, 15 May 2019 17:00:00 -0400 The projects that is have worked on, the milestones were the body of the project. I think that missing milestones can result in failure of the project. At least in the projects that I have worked on all the milestones…   Read more»

]]> 2559eed03409efb29e1d36715b8f55ca https://medicaldevicecourses.com/activity/p/12779/ Wed, 15 May 2019 16:59:05 -0400 I think the monitoring and control. In my experience, seldom I have been a part of a project and all phases ran it course smoothly without monitoring it and making sure that when the planning is being don’t that the…   Read more»

]]> cb65dabbe23b66ab0d5ccb7e49b8542d https://medicaldevicecourses.com/activity/p/12778/ Wed, 15 May 2019 16:59:04 -0400 I worked on a project to validate some of our labs that were doing GxP work with non-GxP work. The idea was to make all the work GxP and have it follow GxP procedures. One of the biggest problem that…   Read more»

]]> 76b15e95a7287a327e03bf1f5ce3d776 https://medicaldevicecourses.com/activity/p/12777/ Wed, 15 May 2019 16:59:04 -0400 About 6 months ago when I worked in validation, mw group worked on a project where we did a media simulation in collaboration with the manufacturing department. There were one other group managing that project and it was the first…   Read more»

]]>