https://medicaldevicecourses.com/members/msc52njit-edu/activity/ Activity feed for msc52njit-edu. Fri, 24 Apr 2026 18:53:59 -0400 https://buddypress.org/?v= en-US 30 hourly 2 5874cfaaeae24266305a4f9415a89221 https://medicaldevicecourses.com/activity/p/17328/ Wed, 15 May 2019 21:38:35 -0400 Yes I think that there is a difference between a verbal and a written contract. A written contract can be more in depth where one party will take more time and room to outline some rules, agreements and restrictions in…   Read more»

]]> a6376cd97db0ec60c99e64b57543515b https://medicaldevicecourses.com/activity/p/17327/ Wed, 15 May 2019 21:38:34 -0400 I think that these restrictions are necessary because there is always someone trying to abuse their privileges or power to better themselves even though they will be hurting other people. If the market can be controlled by persuasion through expensive…   Read more»

]]> 327ecddb7c9bca06c0d23f7fbbb3ac78 https://medicaldevicecourses.com/activity/p/17326/ Wed, 15 May 2019 21:38:34 -0400 This course has been extremely helpful in teaching me the background knowledge and divisions of medical device development. I learned about what division I would enjoy the most working in and what divisions such as Regulatory I would not enjoy…   Read more»

]]> 3d0fb96835fc88e1e73db9951a2c1e15 https://medicaldevicecourses.com/activity/p/17257/ Wed, 15 May 2019 21:38:00 -0400 I work in a functional based organization where I work with only other quality engineers. We coordinate with each other on our own projects and will only reach out to other organizational groups when our projects overlap our when we…   Read more»

]]> cddd149c5c014e4b3d3da94e654dbb73 https://medicaldevicecourses.com/activity/p/17256/ Wed, 15 May 2019 21:38:00 -0400 I think it would be more challenging for a project manager to work in a matrix based organizational project. In the matrix based project you must coordinate with other functional departments more and must structure your project around other department…   Read more»

]]> 92740e2f90bb72f0601c5e018a9f9e91 https://medicaldevicecourses.com/activity/p/17255/ Wed, 15 May 2019 21:37:59 -0400 For me personally I think I would be better suited for Middle management based on my experience in the medical device industry. I think to be in upper management you need a lot of experience that will better prepare you…   Read more»

]]> 1726115a03842d3a2459375a72485785 https://medicaldevicecourses.com/activity/p/17123/ Wed, 15 May 2019 21:36:50 -0400 In order to run a risk management meeting I think the risk manager must first take time to assess all possible rise, give them a severity ranking and point out areas where risk are more likely to occur. Then once…   Read more»

]]> 1ead370f2b5d54737f857b793b443744 https://medicaldevicecourses.com/activity/p/17122/ Wed, 15 May 2019 21:36:50 -0400 I think that these regulations cost money because they provide a platform that companies can use, where if they follow these guidelines, they will be recognized as a company who abides by these set out standards and who provides safe…   Read more»

]]> d385156a5a2fe31b63c83b7d4b9f0b34 https://medicaldevicecourses.com/activity/p/17121/ Wed, 15 May 2019 21:36:49 -0400 Based on the options for Risk Management, choosing mitigation would be my selection for a low severity risk. If the risk is not severe there can be a way to mitigate the risk to reduce the severity level to a…   Read more»

]]> 6310a3d743a532f1910d0cb05a2e50bc https://medicaldevicecourses.com/activity/p/17050/ Wed, 15 May 2019 21:36:15 -0400 From my experience working in the medical device field I have had to sit on design review meetings that dealt with going over the validation process of multiple documents. The meetings are run by the project leader who will open…   Read more»

]]> 3ba86f8312525e6b54d9374a80cb893b https://medicaldevicecourses.com/activity/p/17049/ Wed, 15 May 2019 21:36:14 -0400 I believe verification is important because it makes sure that the device you are creating is exactly as you intended it to be, so that there are no unanticipated problems that may occur later on. By verifying that the device…   Read more»

]]> 809f863fc82d4f5f6af3702d62184e17 https://medicaldevicecourses.com/activity/p/17048/ Wed, 15 May 2019 21:36:14 -0400 The advantages of having each document is that it gives the team time to plan out their design study and to get a general idea of what they need their product to be. With the DID the team is able…   Read more»

]]> a64ea7e71b7db3086be8ff84410e89b6 https://medicaldevicecourses.com/activity/p/16921/ Wed, 15 May 2019 21:35:07 -0400 Some potential problems from not following the design controls process and using the process wrong is to have major delays or changes in your device. By being too specific in documents such as the DID and DSD you may run…   Read more»

]]> 2eedd6bb4eb3782688fd2a5e988ed5ab https://medicaldevicecourses.com/activity/p/16920/ Wed, 15 May 2019 21:35:06 -0400 In terms of determining whether to perform validation or not, validation should still be conducted in order to keep better understanding the product, and that human factors evaluation should be completed as well. Even if there were no changes to…   Read more»

]]> f5acc128fdf91f2c96ef25431fe012f6 https://medicaldevicecourses.com/activity/p/16919/ Wed, 15 May 2019 21:35:06 -0400 Design Controls are a critical component of every project and provide the necessary checks to ensure that all devices are safe for use and meet their intended use. Design Controls will monitor the steps that you take in designing and…   Read more»

]]> 31c69fe8438f3bb04eaef4a2199126e3 https://medicaldevicecourses.com/activity/p/16824/ Wed, 15 May 2019 21:34:12 -0400 Placebo controlled trials are ethical if the individual who is not receiving the correct treatment, is not in serious danger regarding their health. They are also ethical because all individuals have to sign an informed consent form beforehand, agreeing that…   Read more»

]]> 9219313ae874357c9c174e9892ee96fb https://medicaldevicecourses.com/activity/p/16823/ Wed, 15 May 2019 19:42:59 -0400 I believe obtaining informed consent in any medical setting or research setting is very important and necessary. Doctors and hospitals are meant to help and assist patients not secretly be using these regular patients who come to them for their…   Read more»

]]> 597e14f801b55fb2aa73dc6a9657d7de https://medicaldevicecourses.com/activity/p/16822/ Wed, 15 May 2019 19:42:58 -0400 When it comes to handling clinical research I think it is a necessity to have some sort of clinical background or to have undergone a period of clinical training and observation before you can be in a clinical setting. As…   Read more»

]]> 3e85a1818e78ca6006f4c502fb646082 https://medicaldevicecourses.com/activity/p/16708/ Wed, 15 May 2019 19:41:50 -0400 Some ways that company’s are engaging in Participation is through surveys, questionnaires, and special deals for customers. For instance, after you visit a company’s website, buy a certain product online or fill out a form on a company site, they…   Read more»

]]> 26325ae9932260d6ad5ec770c559c0f2 https://medicaldevicecourses.com/activity/p/16707/ Wed, 15 May 2019 19:41:49 -0400 I believe that when it comes to marketing, manipulation is the key component to success. Most customers at the time do not know that a product exist, do not know why they should buy the product, or do not know…   Read more»

]]> 5f853d0a1373273c5e5df2ae160f6ee2 https://medicaldevicecourses.com/activity/p/16706/ Wed, 15 May 2019 19:41:48 -0400 Emotional Intelligence (EI) is an individuals ability to interact and understand other individuals mood, behavior, wants and needs. EI will affect selling because it can allow a sales person to choose and say the right things to a customer. By…   Read more»

]]> 59a4a6fe3c962b8acdca387082638ba8 https://medicaldevicecourses.com/activity/p/16585/ Wed, 15 May 2019 19:40:35 -0400 As a midsized company with 10 million in revenue I would say that they company become a Inc instead of a LLC. As a company that wants to grow they need to start giving investors stock options so that they…   Read more»

]]> 378b44961107e17b5b45fe23d669facc https://medicaldevicecourses.com/activity/p/16584/ Wed, 15 May 2019 19:40:35 -0400 I believe my answer would change based on the characteristics of the company I am looking to start up, but in general I would be most comfortable starting up a Limited Liability Partnership (LLP). The advantage I see with the…   Read more»

]]> 03e3362d6472826b8850e2e8c42a5535 https://medicaldevicecourses.com/activity/p/16583/ Wed, 15 May 2019 19:40:34 -0400 The difference between private and public companies is that private companies do not trade their shares and stocks to the public, so they can maintain all of their finances internally without having to submit financial reporting for their investors to…   Read more»

]]> 81425061cfb05b9baf67d765a9d231fd https://medicaldevicecourses.com/activity/p/16485/ Wed, 15 May 2019 19:39:42 -0400 A good way to improve relations with the Quality department and other departments such as the R&D department, is to spend more time in the planning phase. Here you can create a more detailed outline of what is expected from…   Read more»

]]> e1b11d31e9c0bb9667b411432ca6163a https://medicaldevicecourses.com/activity/p/16484/ Wed, 15 May 2019 19:39:41 -0400 I do not think that Quality is a burden and that companies should focus on hiring the right quality personnel so that they do not need an excess of quality employees. Without Quality a company puts a lot more stress…   Read more»

]]> 868cf46e321f550a0d3bd027d0982f72 https://medicaldevicecourses.com/activity/p/16483/ Wed, 15 May 2019 19:39:41 -0400 I believe that both departments are necessary and need each other in order to work. Quality is very important because it helps with FDA regulations and making sure that the company and the employees do not get sued or fired…   Read more»

]]> 4a3163b212f866681c24522946b50b2b https://medicaldevicecourses.com/activity/p/16381/ Wed, 15 May 2019 19:38:42 -0400 Yes, the FDA currently regulates e-cigarettes as well as all tobacco products. May 5, 2016 was when the FDA ruled on electronic cigarettes. https://changelabsolutions.org/does-fda-regulate-e-cigarettes…[Read more]

]]> 2cfb1686183467ecb4dad2bf51760ecf https://medicaldevicecourses.com/activity/p/16380/ Wed, 15 May 2019 19:38:41 -0400 In the medical device department I think that accuracy is making sure the device will perform the necessary actions that it is set out to do, and precision is making sure that the test results you get are consistent with…   Read more»

]]> 16627bdca105634f2393731e8810e494 https://medicaldevicecourses.com/activity/p/16379/ Wed, 15 May 2019 19:38:41 -0400 From my past experience working at two different medical device companies it always seems that the FDA is extremely tough and is very difficult to work with. I do think that FDA is slowing down the process by dragging out…   Read more»

]]> 64c7ac0afd5cf654778fec9cd2ca435c https://medicaldevicecourses.com/activity/p/16297/ Wed, 15 May 2019 19:37:52 -0400 In any situation like this you should guard against pitfalls such as budgeting. With a lab so far away it will cost more money to visit the lab and to meet with the laboratory members for meetings. You should also…   Read more»

]]> 6fa7669cbaac4b65fa74ee3ec5be9893 https://medicaldevicecourses.com/activity/p/16296/ Wed, 15 May 2019 19:37:51 -0400 I would rather do research that will affect the current generation. With current research you have a defined end goal that you can work towards, so you know if your research work is heading in the right direction or if…   Read more»

]]> 89004101984b65fcfac14f67c9d9d9d5 https://medicaldevicecourses.com/activity/p/16295/ Wed, 15 May 2019 19:37:51 -0400 From my personal views I believe that animal testing is necessary for scientific research especially in medical devices, where the devices will be implanted on humans. At this time there is no simulation that can show how the medical device…   Read more»

]]> f00a912a7e8c48246e248167689ad979 https://medicaldevicecourses.com/activity/p/16170/ Wed, 15 May 2019 19:17:53 -0400 From my previous internship experience I had multiple managers when working on my project. This lead to some conflicts as the managers were not always up to date as to what the other manager had told the team to do…   Read more»

]]> d17d7fce1615a7bb9cced4de377e5b43 https://medicaldevicecourses.com/activity/p/16169/ Wed, 15 May 2019 19:17:52 -0400 Give an example of a time when you encountered an obstacle while working on a project that could have resulted in not reaching the deadline. What phase of the project life cycle should you have focused on more to have…   Read more»

]]> 0ef2df43f74e39fdd88b1963cfd05ca8 https://medicaldevicecourses.com/activity/p/16168/ Wed, 15 May 2019 19:17:51 -0400 I do think that the Planning Phase of the Project Life Cycle would be the most important phase of the project since it determines the outcome of the other phases. Poor planning can extend the time it takes to complete…   Read more»

]]> 6a25e8ec956e311c3573e675689850d0 https://medicaldevicecourses.com/activity/p/16072/ Wed, 15 May 2019 19:16:46 -0400 Arguments that go in favor of Academia is that it gives you more security with your job position since you have the ability to gain tenure. This takes off a lot of stress from worrying about losing your job due…   Read more»

]]> 5b465e532af5cf58655a707a7818e2e6 https://medicaldevicecourses.com/activity/p/16071/ Wed, 15 May 2019 19:16:46 -0400 If I were to give advice to Biomedical Engineering students I would say to get involved in research as soon as possible. This will give you critical hands on skills that you may want to use later on in your…   Read more»

]]> 560b4bfd28c97a8343dadb3c2bf13a02 https://medicaldevicecourses.com/activity/p/16070/ Wed, 15 May 2019 19:16:45 -0400 I believe that there should be a ratio of 6 academic classes to 4 practical classes. At the graduate level a large majority of the courses you have taken already have been focused on academia. Academia is very important to…   Read more»

]]> 2ab48fd6cccbb498afa694f644b5893f https://medicaldevicecourses.com/activity/p/15965/ Wed, 15 May 2019 19:15:41 -0400 When looking to decide if we should outsource work and let a CRO do it you must look at your technical and time availability. If your project team is running really behind on schedule because you chose to take your…   Read more»

]]> 47b459130422c59d690219016aa51210 https://medicaldevicecourses.com/activity/p/15964/ Wed, 15 May 2019 19:15:40 -0400 Project management techniques are different for different sized companies because bigger companies have a lot more workers to take care of and a larger budget that could potentially be wasted or misallocated. Even though both companies will have project managers…   Read more»

]]> 2ed4bef217a282ea0650d87f7238c1d4 https://medicaldevicecourses.com/activity/p/15963/ Wed, 15 May 2019 19:15:39 -0400 When preparing your budget for a clinical trial you need to first have a well defined schedule broken down. The schedule should be made first so you can see where money will have to be spent at certain times and…   Read more»

]]> bc61701c297d2a40d943adda01a1f5f5 https://medicaldevicecourses.com/activity/p/15847/ Wed, 15 May 2019 19:14:31 -0400 What motivates me to work is being in a company that will allow me to work in a field I enjoy and in a company that will allow me to grow and expand my knowledge. These are usually correlated with…   Read more»

]]> 81c1cb116ca97559f84f4a50d4c57875 https://medicaldevicecourses.com/activity/p/15846/ Wed, 15 May 2019 19:14:31 -0400 I believe that there is a correlation between wanting to quit because of lack of praise and you wanting to work because of exciting challenges. The correlation exist in that a worker is motivated to take on and accept harder…   Read more»

]]> 0fcce222f99478e832c3db6741249b85 https://medicaldevicecourses.com/activity/p/15845/ Wed, 15 May 2019 19:14:30 -0400 I believe that Americans are working longer than 40 hours a week because they are motivated to outcompete their fellow peers. The job market today is very competitive and in order to keep your job you need to be outperforming…   Read more»

]]> 08d774cfbc950f774d4bfeacdf665309 https://medicaldevicecourses.com/activity/p/15717/ Wed, 15 May 2019 19:13:12 -0400 In my opinion I believe that another coating from the same supplier does not satisfy the dual source requirement. From our second simulation we saw that companies will produce different results based on their testing and production methods. If you…   Read more»

]]> 682c4217e78db2489e1a7c038d3d9e10 https://medicaldevicecourses.com/activity/p/15716/ Wed, 15 May 2019 19:13:11 -0400 For my senior design project in my undergrad our project team was working on developing a portable ultrasound device with micron position tracking to generate automated robust 3D images that can be used to diagnose scoliosis. Our project team had…   Read more»

]]> a21c61b39733c3ec4bf735bd4369b109 https://medicaldevicecourses.com/activity/p/15715/ Wed, 15 May 2019 19:13:10 -0400 The Human Resource Management department is important in improving the devices and project by helping to monitor and control the members of the project team. Human Resources is important in hiring the right personnel for the company and they can…   Read more»

]]> bc6ff4ed5dbf5d9a660db5ba6abd3a20 https://medicaldevicecourses.com/activity/p/15575/ Wed, 15 May 2019 19:07:49 -0400 Based on our lecture notes it is important to develop a final closing document with all the project details enclosed in there. Based on performance reports it is good to talk to all members of the team, make sure they…   Read more»

]]> 094b035aceb7aae9b833891793e9c2b7 https://medicaldevicecourses.com/activity/p/15574/ Wed, 15 May 2019 19:07:48 -0400 In the execution phase when dealing with failure in the experimental phase, the first thing to do is to rerun the experiment but have different individuals perform different tasks to make sure that the tasks are initially completed correctly. Then…   Read more»

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