https://medicaldevicecourses.com/members/tn58/activity/ Activity feed for tn58. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 21c537a7c8c305655a0446dd06f20420 https://medicaldevicecourses.com/activity/p/12556/ Wed, 15 May 2019 16:57:06 -0400 Agreeing with anyone, I will take the next step forward and think about this from a different point of view. Regardless of who is responsible. I think its a loss to the project manager as well as the entire team….   Read more»

]]> d701b47bd4285f40d10ac2621cd4591f https://medicaldevicecourses.com/activity/p/12544/ Wed, 15 May 2019 16:57:00 -0400 Agreeing with everyone, I would add my experience with CROs. I had multiple interviews to work as a clinical associate or project associate with these organizations. And during the interview process and the tour of the facilities, I noticed that…   Read more»

]]> 58d5d9aed6f43c78b18106d671f66651 https://medicaldevicecourses.com/activity/p/12543/ Wed, 15 May 2019 16:57:00 -0400 I completely agree with Betty, many of my friends who work in the industry faced similar situations. Jobs that I personally try so hard for and constantly applying to work a job a friend of mine has. And the person…   Read more»

]]> 697708b83f91fc60fe514ec1dac34ddd https://medicaldevicecourses.com/activity/p/12542/ Wed, 15 May 2019 16:56:59 -0400 Agreeing with everyone, I would like to share my experience. I have been working as a Project Coordinator for almost an year now. Since I mastered the software, paperwork, and how to work with different departments for my program. It…   Read more»

]]> b24f82771a477e416c99d7e21185bc1f https://medicaldevicecourses.com/activity/p/12455/ Wed, 15 May 2019 16:56:12 -0400 To be honest, after speaking with a lot of people who work in the industry and have several years of experience. I don’t find these results to be surprising. Especially meaningful work/make a difference and benefits being the lowest. A…   Read more»

]]> 7425e996de7f999cf03cb009108ceb35 https://medicaldevicecourses.com/activity/p/12450/ Wed, 15 May 2019 16:56:09 -0400 Your last two words meeting expectations raised another very important question. What if the CROs do not meet the expectations or deliver the expected result? And I agree with your choice of responsibilities that will be better if handled by…   Read more»

]]> ceb464e192752a9388512857be3369f6 https://medicaldevicecourses.com/activity/p/12449/ Wed, 15 May 2019 16:56:09 -0400 Deadlines motivate me to finish my work on time. As a project coordinator, my entire program is run on a deadline as well as the work breakdown structure for everyone. I make sure all of the tasks are completed 1…   Read more»

]]> 344f66719d7d97aafd90b8690ac1cc48 https://medicaldevicecourses.com/activity/p/12448/ Wed, 15 May 2019 16:56:09 -0400 Project managers motivation is critical in a team. Each team member needs to look up to the project manager and be comfortable with the deadlines, and tasks assigned. As a project manager, your motivation, your time management skills and your…   Read more»

]]> 391e2e686bdae6897efc7bdccad890ce https://medicaldevicecourses.com/activity/p/12365/ Wed, 15 May 2019 16:55:20 -0400 In addition to your the previous input, it would depend on the type of nonconformity. For example, after googling examples. I became aware that that there are three types of nonconformities: minor, major, and critical. Minor nonconformity would be when…   Read more»

]]> 3f96dc23c4a28651c8c0d4b978fc1784 https://medicaldevicecourses.com/activity/p/12364/ Wed, 15 May 2019 16:55:19 -0400 Agreeing with neb2, I would add that it order to simply put it in words and grasp it. It is a system that is used to avoid or eliminate undesirable outcomes or events. It is there to make sure we…   Read more»

]]> cc78b9e7394dea7478efb632a211b76e https://medicaldevicecourses.com/activity/p/12363/ Wed, 15 May 2019 16:55:19 -0400 As the person above me went into great detail about the pros and cons of internal audits. I will add that it depends on the company you are working with. Some companies may play tricks to hide any inefficiencies while…   Read more»

]]> 210e881ece240ece91084dac365acd0c https://medicaldevicecourses.com/activity/p/12359/ Wed, 15 May 2019 16:55:17 -0400 One of my CAD projects was modeling a hip stem implant. This one project turned into two different projects. Initial project was to make a 3D hip stem implant using creo and focus on design specification and just created a…   Read more»

]]> 1cd09aec1ace7efc81d0477b486ce45d https://medicaldevicecourses.com/activity/p/12354/ Wed, 15 May 2019 16:55:14 -0400 I am a project coordinator for the ELA program. The program was initially started to put students with below a 2.5 on a academic probation list and to hire tutors specifically these students. This would allow the students to make…   Read more»

]]> 95a04160581740110be71c05f6076982 https://medicaldevicecourses.com/activity/p/12282/ Wed, 15 May 2019 16:54:28 -0400 Agree with your input. This takes us back to the importance of GMPs. Yes they may be time consuming and hectic but the people who came up with GMPs did it for a reason. If there was no GMPs or…   Read more»

]]> e22021a57aaf2191a0d4af74f8d5ba45 https://medicaldevicecourses.com/activity/p/12277/ Wed, 15 May 2019 16:54:26 -0400 I do not agree that they make the process more difficult for companies or set companies up for initial failure. I think they are essential in order to succeed in the long run. If these GMPs did not exist then…   Read more»

]]> 8876abf276aa7ff9bf18e1c8e2cd47a8 https://medicaldevicecourses.com/activity/p/12269/ Wed, 15 May 2019 16:54:22 -0400 I don’t have any experience working in the industry. But I will add that each company is different. From my graduate students who worked in the industry each share a different point of view depending on the company they work…   Read more»

]]> e28b4d69633387173fb12619b592cb45 https://medicaldevicecourses.com/activity/p/12268/ Wed, 15 May 2019 16:54:21 -0400 One example of product risk would be failing of a software used in a product. As an engineer, I would verify and validate the software used in the product during the executing process. Once the software is validated, any component…   Read more»

]]> 0041db3bfc91303b253a162652d1dc05 https://medicaldevicecourses.com/activity/p/12249/ Wed, 15 May 2019 16:54:11 -0400 Thank you everyone for sharing your response. Glad to hear everyone agrees with my original post. Adding to that, I will definitely agree with jnm22 that both are essential and that interpersonal skills do tend to weigh more regardless of…   Read more»

]]> 4d0494dfe228dc03ee3173e3d2444329 https://medicaldevicecourses.com/activity/p/12237/ Wed, 15 May 2019 16:54:05 -0400 Agreeing with everyone above, I will add that yes some products do not follow the traditional path. Some products may not cost you a lot during any of the phases and end up giving you the most increase in sales…   Read more»

]]> 27120745c70176d17e58c7e67b83813c https://medicaldevicecourses.com/activity/p/12176/ Wed, 15 May 2019 16:53:31 -0400 As Viraj and Luisa gave examples of recalling of products. I will add that companies face a lot of financial troubles when the device is being recalled. As any industry has competitors, it gives your competitors a chance to copy…   Read more»

]]> 519aaa87aa2967fceef03b04c233cd56 https://medicaldevicecourses.com/activity/p/12160/ Wed, 15 May 2019 16:53:23 -0400 Product Introduction is also very important as it follows after Planning and Development. Some of the key aspects in Product Introduction are reviewing project at regular intervals and begin establishing connections to customers. Keeping track of the project during the…   Read more»

]]> 10953942493e6d76c3804f665f700606 https://medicaldevicecourses.com/activity/p/12159/ Wed, 15 May 2019 16:53:22 -0400 One of my graduate courses I took at NJIT, our final project was to make a product which isn’t on the market and sell the product to your classmates (who were investors, private companies etc). My partner and I came…   Read more»

]]> dd54d8f8ca8d7124f3cbf07464c1f1ef https://medicaldevicecourses.com/activity/p/12158/ Wed, 15 May 2019 16:53:22 -0400 Keeping a log for my current positions is critical. Each meeting, each dollar spent, each appointment, and summary of the nature of the appointments must be submitted to the Director of the EOP program. As a Project Coordinator, I am…   Read more»

]]> 1bf8aeedf5134b34212f9d6b899abec3 https://medicaldevicecourses.com/activity/p/12157/ Wed, 15 May 2019 16:53:22 -0400 I currently work as a Project Coordinator for NJIT in which I am coordinating an entire project from training to payroll, to dealing with students and tutors. Initially, it was planned each tutor can make up to $700 per semester…   Read more»

]]> eefaa84da37ff953cafef787671a4680 https://medicaldevicecourses.com/activity/p/12100/ Wed, 15 May 2019 16:52:47 -0400 As Betty explained the tasks needed to be performed by the PM to obtain accurate assessment of quality assurance of the project. To add to the next step, I would say that executing process, design verification and validation are where…   Read more»

]]> cf58e43cd0d899458162370a8b343e9e https://medicaldevicecourses.com/activity/p/12098/ Wed, 15 May 2019 16:52:46 -0400 Agreeing with Betty, another challenge a project manager faces is budget information. Often times, budget information is not distributed to project managers and they are unable to time their projects. And often times when the project is almost finished but…   Read more»

]]> d32639a58921fc70b050b4ffaf1418d1 https://medicaldevicecourses.com/activity/p/12097/ Wed, 15 May 2019 16:52:46 -0400 First of, I would talk to the individual team member to make sure everything is going well. As a project manager, it is your duty to make sure each member of the team is in the right mind when coming…   Read more»

]]> 2d3a172a0f350e45adbb7b6013511da7 https://medicaldevicecourses.com/activity/p/12040/ Wed, 15 May 2019 16:52:16 -0400 In my opinion, it would depend on the company. Original validation would expire because changes are made within equipment and those changes need to be validated to assure that the equipment will produce accurate results. It would be a on…   Read more»

]]> d82ba69cc83a5e740c3706ce0ab1cb22 https://medicaldevicecourses.com/activity/p/12004/ Wed, 15 May 2019 16:51:53 -0400 I’m not sure exactly what your question is asking. But in my personal opinion I do not think missing a milestone is a link to future success for a company in the long run. For example, when you miss a…   Read more»

]]> d5f8bf6630c3fdb9d3da894fa98894cd https://medicaldevicecourses.com/activity/p/12003/ Wed, 15 May 2019 16:51:52 -0400 If I was a project manager for this week’s simulation in a real life situation. I would get in contact with everyone from day 1 so there is no falling behind. I would make a WBS and assign parts of…   Read more»

]]> e75c174c9f780f81b624b5959d8914ee https://medicaldevicecourses.com/activity/p/11949/ Wed, 15 May 2019 16:51:23 -0400 I do not think the processes have to be revalidated because of multiple locations. However, I will add that the quality team may have argued this if they saw that each location would impact the equipment in someway which may…   Read more»

]]> de028bf6262c0c9d41a0b2f6f316f051 https://medicaldevicecourses.com/activity/p/11917/ Wed, 15 May 2019 16:51:00 -0400 Adding to what Hiren Rana said, not only will the project manager need to allocate more time for R&D. The test protocols may need to revised. This would take more time and causing a delay in the tasks down the…   Read more»

]]> c9399251b7b5047b849c7ac2680b4d91 https://medicaldevicecourses.com/activity/p/11916/ Wed, 15 May 2019 16:50:59 -0400 Sharing my research experience, I was doing a computational study on the BCR phili gene. The entire research project was broken down into multiple parts: Computational Data, Analysis, Literature comparison, and finally presenting my findings to a committee in order…   Read more»

]]> a59fea2650bfc1f0e00fcfc30f8f203a https://medicaldevicecourses.com/activity/p/11900/ Wed, 15 May 2019 16:50:51 -0400 I think Verification can occur anytime during a project. I do not have any industry experience but theoretically speaking Verification can occur at any point. It can also occur during the research phase where making a change in your project…   Read more»

]]> b8240e3f805d9b1fc8d07cf9702fc45b https://medicaldevicecourses.com/activity/p/11880/ Wed, 15 May 2019 16:50:40 -0400 In designing a hip stem implant and running finite element analysis on it last semester. After creating the part file which took hours, and applying constraints and loads on the hip stem implant. After running 20 analysis to predict where…   Read more»

]]> fc65c0aa961f927e14b43da17f8266ca https://medicaldevicecourses.com/activity/p/11859/ Wed, 15 May 2019 16:50:27 -0400 Not knowing your budget can limit your team members. For example, when you hire people for a project they work at a specific rate. So if you do not know your budget it can be problematic in getting the team…   Read more»

]]> d29030e05bd389b278d5db8a97bd9e13 https://medicaldevicecourses.com/activity/p/11854/ Wed, 15 May 2019 16:50:24 -0400 My opinion on this is, SOPs should not be required during the research phase. The main reason behind this is that during the research phase your project can take multiple phases. There could be second opinions or alternative ideas involved…   Read more»

]]> 0cbb434775fd90a3722be532fdcffe41 https://medicaldevicecourses.com/activity/p/11853/ Wed, 15 May 2019 16:50:23 -0400 Agreeing with everyone here, in addition I would say the SOPs should be written so someone with a high school education can read them without any confusion. Also, it varies from project to project. Some projects require a lot of…   Read more»

]]> 60800dd2bd7b88edde2d150c7a6983b8 https://medicaldevicecourses.com/activity/p/11852/ Wed, 15 May 2019 16:50:22 -0400 I do not have any work experience in this field. However, from what we learned so far. I would choose the second option you posted. Reason being is the work instructions step. This is vital in any Quality Management System…   Read more»

]]> c9e7dba1fc508a800096d548c56ddaa6 https://medicaldevicecourses.com/activity/p/11799/ Wed, 15 May 2019 16:49:50 -0400 As everyone already answered the initial question in full detail. I would like to add why I believe it is important to have post market surveillance. Yes it gives companies feedback and how to better future products or if a…   Read more»

]]> 7c3b6e5e34700f91ed0aa40ae1f07f09 https://medicaldevicecourses.com/activity/p/11798/ Wed, 15 May 2019 16:49:50 -0400 I personally take women’s one day multivitamin as recommended by my doctor. During undergraduate years, I was going through extreme stress and anxiety with college courses as well as work life. This resulted in loss of appetite and dehydration and…   Read more»

]]> 0e47e62cb8ae96e9aa52ce8bae25834e https://medicaldevicecourses.com/activity/p/11797/ Wed, 15 May 2019 16:49:49 -0400 My personal experience as a coordinator of a program at NJIT (non-medical). I would prefer a team who actually is passionate about the project. As a coordinator, I am responsible for 50 students and 6 tutors. My entire project depends…   Read more»

]]> 138c88f4a21af974dd1a9dcb4dd5c82a https://medicaldevicecourses.com/activity/p/11775/ Wed, 15 May 2019 16:49:38 -0400 I have no experience in the industry, but based on what I know about ECO from Dr. Simon’s course, I would only use an ECO for profits. For example, if there is a major change that needs to occur in…   Read more»

]]> 58f92f7efe047b00cf9d08d5db5f5dba https://medicaldevicecourses.com/activity/p/11728/ Wed, 15 May 2019 16:49:06 -0400 Initiating a project idea is the hardest part of project development because if done incorrectly, your project will fail and you will waste time and money. So how would one avoid this? This is where business and market research play…   Read more»

]]> f13c35b514db8bc8adb434f5784aa4a2 https://medicaldevicecourses.com/activity/p/11726/ Wed, 15 May 2019 16:49:05 -0400 My opinion applies to the business case especially coming from a family who owns and runs a business. A good project manager can run a business case based on his analytical skills and critical thinking. Before even getting to the…   Read more»

]]> c39d34d7c2214fbaab80bcfff39ad70c https://medicaldevicecourses.com/activity/p/11722/ Wed, 15 May 2019 16:49:02 -0400 I agree with everyone. But looking at it from a different point of view.Cutting regulations will save more terminal patients however cutting down regulations can also be harmful for the long term. If a drug is approved based on minimal…   Read more»

]]> cfa5300230b32bb26272d062b4fce2ac https://medicaldevicecourses.com/activity/p/11720/ Wed, 15 May 2019 16:49:01 -0400 Yes it is a living document and i agree with everyone here. However, you can’t look at this like a file on your laptop. These changes and processes actually cost money and time. When you are hired for a project,…   Read more»

]]> f4b82508a938d0ee85546f4f3a84ec8e https://medicaldevicecourses.com/activity/p/11718/ Wed, 15 May 2019 16:49:00 -0400 It would depend on the client’s requirements. In many cases, the client may specifically require you to re-execute the entire verification and validation protocals. This can be costly but if the client does not receive the expected results, that would…   Read more»

]]> 1c374380b6de0eaf588cb648fcdf25d8 https://medicaldevicecourses.com/activity/p/11710/ Wed, 15 May 2019 16:48:55 -0400 Agreeing with everyone, yes both of the files are useful and in some instances as mentioned above, one file is more useful than other. But at the end of the day, both files are there for a reason. My personal…   Read more»

]]> e968d20fdce108b3bdacfbab56dfe409 https://medicaldevicecourses.com/activity/p/11612/ Wed, 15 May 2019 16:48:05 -0400 My understanding of it is, that it depends on case to case bases. It depends what your drug, device, or both intend on doing. Keep in mind, some risks may not appear in short term clinical trials. Or they may…   Read more»

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