https://medicaldevicecourses.com/members/za84njit-edu/activity/ Activity feed for za84. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 bc1b264ed57e838fd4e2d3a38c40d76e https://medicaldevicecourses.com/activity/p/18359/ Wed, 15 May 2019 21:47:37 -0400 To address the points raised by colleagues, I would like to share a personal work experience as told to me by my friend. She said: “… I was working as part of an IT entity in a major university in…   Read more»

]]> e2e685ebab6d2d8950820ea947fe850f https://medicaldevicecourses.com/activity/p/18355/ Wed, 15 May 2019 21:47:35 -0400 I agree with most ideas brought up by my colleagues regarding the qualities a manager should possess. In addition, I would like to add that an excellent manager is someone whose radiating enthusiasm is felt by the employees in the…   Read more»

]]> 0795872ec2fd2108b7575092380e7fd0 https://medicaldevicecourses.com/activity/p/18352/ Wed, 15 May 2019 21:47:33 -0400 For me, it was very helpful in a way that it taught me about the real life of a biomedical engineer in industry and after school, since most classes focus only on the technical part of being an engineer, neglecting…   Read more»

]]> dbbe2d0fa2f10d9b27234333242c861d https://medicaldevicecourses.com/activity/p/18293/ Wed, 15 May 2019 21:47:02 -0400 That is an interesting question to think about. For me, I would certainly work several years as an engineer, as I learned a lot in my engineering years during undergrad and grad school. I think it will be hard for…   Read more»

]]> 6711837324621f0a8df1cdb57ba94a0a https://medicaldevicecourses.com/activity/p/18269/ Wed, 15 May 2019 21:46:50 -0400 That was an interesting study! However, I was not very surprised with the results. Although most people think that the “Fair Pay” is the main reason that would an employee to keep working, I think it is not easy to…   Read more»

]]> edaf8fa7914e0c23cd5111cc0561a1c1 https://medicaldevicecourses.com/activity/p/18268/ Wed, 15 May 2019 21:46:49 -0400 It is very essential in any team to have some sort of enthusiasm regarding the project in order to perform their best and have the highest level of productivity. This can be certainly directed by the project manager in most…   Read more»

]]> 1dbd4c7fa0e0f1e0451d0b45c84ac8b7 https://medicaldevicecourses.com/activity/p/18152/ Wed, 15 May 2019 21:45:49 -0400 After the team development, execution process should work on the planned timeline by team members in which each should perform the assigned tasks on the planned time. However, during any possible employee absence or vacation, the project manager should have…   Read more»

]]> 0b218aef6c1d08b80026489a5377941f https://medicaldevicecourses.com/activity/p/18149/ Wed, 15 May 2019 21:45:48 -0400 Although there are many important factors that would affect project planning and execution a project manager should focus on, I would emphasize on choosing the right person (team member) for the right task. Spending some time learning about team member’s…   Read more»

]]> ef1ec7d5d8aef3a6baa8fb0918c68606 https://medicaldevicecourses.com/activity/p/18147/ Wed, 15 May 2019 21:45:47 -0400 I do agree with all these points, each would play a critical role in project success as it all depends on each other in a way or another. For me, I would add another two important aspects that would affect…   Read more»

]]> f65058f126078547cad77aa769d46283 https://medicaldevicecourses.com/activity/p/18081/ Wed, 15 May 2019 21:45:14 -0400 Planned value (PV) and actual costs (AC) does matter in the monitoring and controlling phase as both are essential for the controlling and monitory phase as each would have a direct impact on the project budget. PV is defined as…   Read more»

]]> 48d12ff29205fb4db3cc2a5b1250d514 https://medicaldevicecourses.com/activity/p/18078/ Wed, 15 May 2019 21:45:13 -0400 In my opinion, although there are many important monitoring and controlling techniques in the phase of the design control, I believe that for a team to success in the execution stage, it is important to ensure and check that plan…   Read more»

]]> a28f625913336879f8973b68e59e6b64 https://medicaldevicecourses.com/activity/p/18073/ Wed, 15 May 2019 21:45:10 -0400 Due to the PMI website definition, schedule variance (SV) is the difference between the earned value (EV) and the planned value (PV). [SV = EV-PV]. There are several factors that could affect the schedule variance negatively in any project. It…   Read more»

]]> 045920718767e6443f184c3fbc27f2c6 https://medicaldevicecourses.com/activity/p/18015/ Wed, 15 May 2019 21:44:38 -0400 It is true that managing duration in a project is one of the hardest tasks for the PM to handle ideally. Even though all task durations were arranged and planned precisely, some out-of-control issues could appear at one point and…   Read more»

]]> 1b9d6b385fd235151ebe6849534c8595 https://medicaldevicecourses.com/activity/p/18012/ Wed, 15 May 2019 21:44:37 -0400 In my opinion, a planning phase is very important, a successful plan has to be built up in a way that allows for dynamic changes. In other words, when the need for revisiting an earlier phase (ie. planning phase) a…   Read more»

]]> ede5417e585eccb70e8d7d2feca32d70 https://medicaldevicecourses.com/activity/p/18010/ Wed, 15 May 2019 21:44:36 -0400 In order to avoid such a delay issue, a project manager should initially contact multiple vendors, and get all the information he/she needs for the product. This would give flexibility on time and flexibility to switch to any other alternative…   Read more»

]]> 8fd00d428d7a0d78b40d554f54dcfd04 https://medicaldevicecourses.com/activity/p/17944/ Wed, 15 May 2019 21:44:03 -0400 Although task scheduling is very essential in the project process during the planning phase, setting a risk management plan and a backup strategy is a must. these risks could be caused by the organization and management, the development internal/external environment,…   Read more»

]]> 56272328bd35929c033d68186e038668 https://medicaldevicecourses.com/activity/p/17940/ Wed, 15 May 2019 21:44:01 -0400 In my senior design for my undergrad, I found it very useful to log every single detail in my work. This includes writing tasks to be done, what was done, when and how. I was recording all meetings, and taking…   Read more»

]]> d8c845a68439cc1e1ab1a812f1970e73 https://medicaldevicecourses.com/activity/p/17934/ Wed, 15 May 2019 21:43:58 -0400 I agree with you. All phases are important, and missing one phase could lead to project failure at one point. Project initiating may be the most important as other project management processes would rely on it, such as the planning…   Read more»

]]> d87107b6f4246a0aba1395561c6aed9f https://medicaldevicecourses.com/activity/p/17883/ Wed, 15 May 2019 21:43:32 -0400 If I was the PM, I will try to find a time that members can meet in two different sessions to speed up the process. Also, an online meeting through Google hangout or skype would be appropriate. Another solution could…   Read more»

]]> 731e52ad9d22a682778b62188c0b5c7b https://medicaldevicecourses.com/activity/p/17879/ Wed, 15 May 2019 21:43:30 -0400 It is well known that having a clear milestone in any project plan would make it easier for the PM and the team member to keep track on the project main tasks and to plan important events, meetings, agreements, and…   Read more»

]]> 3e3e41b8db8dc34dddec55ee29bdad3b https://medicaldevicecourses.com/activity/p/17876/ Wed, 15 May 2019 21:43:29 -0400 Due to the PMI website, these are some of the challenges that project managers could face: 1) Ensuring Project Success 2) Preventing Project Failures 3) Enhancing Project Competencies — I would elaborate on the first point from my point of…   Read more»

]]> 78d7302e9b86fc31d9707271c48647d3 https://medicaldevicecourses.com/activity/p/17802/ Wed, 15 May 2019 21:42:45 -0400 As others mentioned, the whole timeline should be reviewed by the project manager and the timeframe for each phase should be reevaluated. Since the device failed in performing its major task as a weight loss aid, more research should be…   Read more»

]]> e828dbe120fa5accdd01a1318f39d68e https://medicaldevicecourses.com/activity/p/17800/ Wed, 15 May 2019 21:42:44 -0400 I don’t think there is a specific way that is the “most efficient” way to brings DID specification to the device. It depends on the device type, design team, etc. I would agree with other replies above, which emphasize that…   Read more»

]]> 11a32ba152dc64f511bbaf1b12ac90aa https://medicaldevicecourses.com/activity/p/17798/ Wed, 15 May 2019 21:42:43 -0400 Design validation is an important factor in project management as it will determine the needed deliverable to ensure that the correct product with the aimed solutions will be delivered to the customers’ needs. In the medical devices industry, in particular,…   Read more»

]]> 9c889a7c141892cedf7b8530dd271482 https://medicaldevicecourses.com/activity/p/17704/ Wed, 15 May 2019 21:41:56 -0400 I have always believed that the overwhelming outcome of shared resources and collaborations would lead to a positive outcome. One of the main benefits of global regulation of medical devices is that scientists and research groups in one country would…   Read more»

]]> aa963f895fb9e42f5dfe722411ae08ec https://medicaldevicecourses.com/activity/p/17701/ Wed, 15 May 2019 21:41:54 -0400 In this week simulation, the experiment forced the team to follow a specific resolving its failure as the project deliverables were stated and the protocol followed in the lab was clarified. In my opinion, it was good to think first…   Read more»

]]> cabbadcaf1e6bf8da2c56d121e18bbc3 https://medicaldevicecourses.com/activity/p/17700/ Wed, 15 May 2019 21:41:54 -0400 Interpersonal skills are the most important qualification an employee can have in my opinion. We all came from an academic background and have certainly encountered many individuals whos interpersonal skills have inspired us. For example, I remember as a freshman…   Read more»

]]> f1dfeb0645c89b64f473502c1410d7ea https://medicaldevicecourses.com/activity/p/17654/ Wed, 15 May 2019 21:41:28 -0400 Although FDA approval is very useful to protect public health thru controlling medical devices and pharmaceutical drugs and ensure safety and effectiveness. Some of the most important points to be followed by the design process team in order to ensure…   Read more»

]]> 22b1f553dcfbd8fbaf69dbb5f08fe24e https://medicaldevicecourses.com/activity/p/17651/ Wed, 15 May 2019 21:41:27 -0400 “While physicians may prescribe medical devices for unapproved uses, a manufacturer may not distribute medical devices in interstate commerce with the intent that those devices be used for unapproved purposes” This sentence in an article on whistleblowerfirm website grabbed my…   Read more»

]]> 86178fe3399502d82b41f9563a9b0e4e https://medicaldevicecourses.com/activity/p/17571/ Wed, 15 May 2019 21:40:43 -0400 A risk is an event or condition that, if it occurs, could have a positive or negative effect on a project’s objectives. Risk Management is defined as the process of recognizing, classifying, evaluating, responding to and managing risks that could…   Read more»

]]> e493d2021d6641b98d8c1b340e7bfbc7 https://medicaldevicecourses.com/activity/p/17554/ Wed, 15 May 2019 21:40:34 -0400 Quality plans are essential in any project, although in many cases the project manager won’t give it the priority. QP can be defined in project management as “a set of planned, systematic actions to ensure that products and services comply…   Read more»

]]> f3f1108990a8ab6329e6842a019c5527 https://medicaldevicecourses.com/activity/p/17553/ Wed, 15 May 2019 21:40:33 -0400 As a biomedical engineering graduate student, I would say one in this field would need both skills (interpersonal skills and technical skills) in a ratio of 50:50. Although I agreed in an earlier reply that “interpersonal skills are more essential…   Read more»

]]> 0f70116bb3fa2ad832d2af992f77a3d0 https://medicaldevicecourses.com/activity/p/17548/ Wed, 15 May 2019 21:40:29 -0400 I would agree with the reviews above which thinks that a product with a peeled off label or similar defects should still be recalled as they may lead to a severe dangerous consequence in some cases. For example, a pain…   Read more»

]]> 3ef88a1afb05853b69c4b6816c56a932 https://medicaldevicecourses.com/activity/p/17487/ Wed, 15 May 2019 21:39:56 -0400 I believe that interpersonal skills are more essential to the work environment especially to teamwork oriented place than technical skills. For example, an engineer could be top-notch in his/her technical skills, but if he/she fails in communicating and explaining their…   Read more»

]]> 4150e728802d58a5aaf97fc3a906e28e https://medicaldevicecourses.com/activity/p/17486/ Wed, 15 May 2019 21:39:56 -0400 Having the right people in the right place in the project would absolutely make the project manager life easier and would make the project flow smoother and would ensure the project success. Choosing the proper team member doesn’t necessary means…   Read more»

]]> 842730b8ed41ba93b3dfd8e6c1d5d70e https://medicaldevicecourses.com/activity/p/17480/ Wed, 15 May 2019 21:39:53 -0400 A project manager should have multiple skills including: “- Leadership – provide direction – provide vision – coach/mentor team members – sound judgment – issue & conflict resolution – effective decision making – Negotiation – Communication – Team building” [Ref….   Read more»

]]> a6625de7182327a9cd5dcced8dddd7a7 https://medicaldevicecourses.com/activity/p/17400/ Wed, 15 May 2019 21:39:09 -0400 I think these restrictions are essentials and would help physicians and employers to avoid many problems at work. I think without any gifts restrictions, some people would go crazy thinking that the more expensive the gift we give is the…   Read more»

]]> 83813f47dd0edb80b96ef10714fc1215 https://medicaldevicecourses.com/activity/p/17399/ Wed, 15 May 2019 21:39:09 -0400 I agree with most replies here, which finds a written business agreement the better option in a project, compared to the verbal agreement, as it and can be easily defended in court and would provide more certainty by stating the…   Read more»

]]> e9e23adcf74dbf1afaca8daf1d941ce1 https://medicaldevicecourses.com/activity/p/17394/ Wed, 15 May 2019 21:39:07 -0400 This was my first online course in my Master degree, and I enjoyed it a lot, and never regret taking it. I like how we learned about different aspects every week, and how this course taught me a lot about…   Read more»

]]> f1e73876aa8de4e4fd00d18a497d1d00 https://medicaldevicecourses.com/activity/p/17310/ Wed, 15 May 2019 21:38:26 -0400 I personally find my talents, skills, and qualifications are more suited for upper management. I believe that what makes a good upper management individual is someone whose leadership skills are strong in the sense that he or she can lead…   Read more»

]]> 0cbb6986fd4e3896d5f86ec30a4675fe https://medicaldevicecourses.com/activity/p/17299/ Wed, 15 May 2019 21:38:21 -0400 Choosing the right members to form a project team is very critical in the workflow and project outputs, thus it is essential to carefully choose the team members. For me, I would focus first on the skills and abilities of…   Read more»

]]> 3dda781ade9e43821ad8a302e1883107 https://medicaldevicecourses.com/activity/p/17297/ Wed, 15 May 2019 21:38:20 -0400 If I were to start up my own medical devices company, I would choose the Matrix Org Structure as I think it would have enough flexibility to work under different bosses, fast to grow, and would have the space for…   Read more»

]]> 55ec62088690cf1045ab7109244e2d70 https://medicaldevicecourses.com/activity/p/17208/ Wed, 15 May 2019 21:37:33 -0400 I think planning is the key to reach the goal of a successful project. The first thing in the process is identifying risks in the project, and understanding each risk and its cause and effect later on the project. Then…   Read more»

]]> 8e03815a11ba74aea5b02816a1336239 https://medicaldevicecourses.com/activity/p/17187/ Wed, 15 May 2019 21:37:22 -0400 I don’t have the industry experience yet, but from what I was reading on the PMI website, I understand that the risk identification is always followed by the risk management planning step. Risks can always be identified through a detailed…   Read more»

]]> ad27d2d1de48ca02605e2fe14c381001 https://medicaldevicecourses.com/activity/p/17181/ Wed, 15 May 2019 21:37:19 -0400 There is no project that is completed without going through any risk (as a part the process), thus, it is necessary to deal with those associated risks in a well-managed way, and avoid mistakes that others did previously in similar…   Read more»

]]> e365c7c8e0554f5b5c59b5bab46a7f7e https://medicaldevicecourses.com/activity/p/17113/ Wed, 15 May 2019 21:36:45 -0400 As for Design Verification, I believe that a necessary practice is to let experts from a different discipline test the product under unusual circumstances. I think that there are circumstances that the product might be used under. While Verification is…   Read more»

]]> 0460793612c52927c779625fa2ce5e48 https://medicaldevicecourses.com/activity/p/17102/ Wed, 15 May 2019 21:36:39 -0400 As mentioned in other discussions, ensuring an adequate design control would lower the risk of a product failure at any point. Design Controls, in general, were explained a lot in this discussion, thus I wanted to discuss in particular the…   Read more»

]]> 0d4dc04bf93118d67cbc01487a11da73 https://medicaldevicecourses.com/activity/p/17099/ Wed, 15 May 2019 21:36:38 -0400 As my classmates mentioned above, insufficient design control would lead to a production failure at one point. And as FDA stated on their website: “Design control does not end with the transfer of a design to production. Design control applies…   Read more»

]]> 8acedd46603eb52ebf0cf1b0eab4e6cf https://medicaldevicecourses.com/activity/p/16994/ Wed, 15 May 2019 21:35:45 -0400 I must agree with most of the discussion points mentioned above, but I would like to point out that for an engineer, the DSD would be a must-read document, as we don’t rely on broad descriptions. For example, an engineer…   Read more»

]]> 979424d929e6ba927e9ad406c6326f75 https://medicaldevicecourses.com/activity/p/16991/ Wed, 15 May 2019 21:35:44 -0400 As Dr. Simon mentioned in the lecture, meeting minutes are very important for any meeting at any project, as it will be a clear and direct proof for any case of project misleading or a role misunderstanding later. In many…   Read more»

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