https://medicaldevicecourses.com/members/jailynp26/activity/ Activity feed for jailynp26. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 3cd574a70738da7b5f85ec6d07ea1ce6 https://medicaldevicecourses.com/activity/p/23686/ Mon, 11 Oct 2021 01:45:57 -0400 Posted by: @orleron Well, you did it! You made it to the end of Medical Device Development. The original intent of this course was to teach you what professionals in the medical device field do in the real world if…   Read more»

]]> a772c6cffc6d2d14f1dfa32bf2d71fc9 https://medicaldevicecourses.com/activity/p/23685/ Mon, 11 Oct 2021 01:36:04 -0400 Posted by: @kbs27 Hi all, In the video lecture Dr.Simon mentioned about two terms of contract,Written & Verbal agreement. He said that verbal contract can be legal but what if the due to dispute or other reason the verbal agreement…   Read more»

]]> 89bf1df43f06c1282f7ed2c1462fa9ab https://medicaldevicecourses.com/activity/p/23683/ Mon, 11 Oct 2021 01:23:16 -0400 Posted by: @amd29 Quite recently Dr. Simon organized us into project teams. And strangely, I became a part of one before I knew it. The approach of forming the team was weird.Personally, after experiencing with the Functional Organizational type in…   Read more»

]]> 8e8c80065de0321602e18837ea1db970 https://medicaldevicecourses.com/activity/p/23603/ Tue, 05 Oct 2021 01:19:15 -0400 A Risk Management File (RMF) is where you keep risk management activities, documentation, and records. A Risk Management File contains proof of Risk Management Plan. Hazard Analysis, Hazard Evaluation. “set of records and other documents that are produced by risk management”….   Read more»

]]> 20c6504ffd1a222992858b73ab9f93b1 https://medicaldevicecourses.com/activity/p/23602/ Tue, 05 Oct 2021 00:39:21 -0400 Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?  I would say anything with pointy or sharp ends, electricity, or ventilators, etc. All…   Read more»

]]> 535cdac99d293c204ee45da62cc57ae1 https://medicaldevicecourses.com/activity/p/23601/ Tue, 05 Oct 2021 00:22:29 -0400 Posted by: @fgk4 The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area…   Read more»

]]> 9b75e48b3e13fc2710e1e5126b236d4f https://medicaldevicecourses.com/activity/p/23498/ Mon, 27 Sep 2021 00:23:13 -0400 Posted by: @tulikadasp Product development is inherently an evolutionary process. While change is a healthy and necessary part of product development, quality can only be maintained if those changes are controlled and documented. Design control involves establishing procedures to identify,…   Read more»

]]> 797e8b68b6454e2579bb5a137716dd39 https://medicaldevicecourses.com/activity/p/23496/ Mon, 27 Sep 2021 00:09:50 -0400 Posted by: @smk45 While watching this week’s lecture on design control, I tried to figure out the main difference between Design Verification and Design Validation. Both are used to make sure that the design outputs align with the design inputs….   Read more»

]]> f602f9d283b472964d7e9d9043688a88 https://medicaldevicecourses.com/activity/p/23493/ Sun, 26 Sep 2021 23:58:17 -0400 Posted by: @hg93 “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and…   Read more»

]]> b02715d45e3bb4b4ee493441a24f8851 https://medicaldevicecourses.com/activity/p/23415/ Tue, 21 Sep 2021 01:15:17 -0400 Posted by: @jr377 This year, the Right to Try act was signed into federal law. This law allows patients to request the use of investigational drugs (without FDA involvement or state law). There was a current “compassionate use” framework, but…   Read more»

]]> bbae5851ad16f98599659401a8c277d7 https://medicaldevicecourses.com/activity/p/23405/ Mon, 20 Sep 2021 03:52:31 -0400 Posted by: @savery115 Clinical trials and research is designed to expose a limited sample of subjects to potential new treatments. Human tests of a medical intervention typically pose risk to subjects despite the amount of laboratory and pre-clinical trails conducted…   Read more»

]]> e5b4329f8053f6fa5fd43110354bc913 https://medicaldevicecourses.com/activity/p/23404/ Mon, 20 Sep 2021 03:11:59 -0400 Posted by: @mejefferson During the current pandemic, there are over 100 vaccines being tested on humans worldwide. The average human today is a subject for a vaccine. Do you think that different vaccines may work on different people due to…   Read more»

]]> e181fd65f1ee95a6bd6c32593989e84e https://medicaldevicecourses.com/activity/p/23295/ Sun, 12 Sep 2021 15:30:56 -0400 Posted by: @jailynp26 YES! research market is needed because it can show you what people are interested in at that time. It can show what is missing from the scenes was well. Focusing on what people are buying and creating…   Read more»

]]> 867987033ae265f73e81762f170c3fd5 https://medicaldevicecourses.com/activity/p/23292/ Sun, 12 Sep 2021 15:18:34 -0400 Posted by: @sahitya-sadineni After watching the videos from this week’s lecture, we have learned about the various company types. While thinking about this, would you consider turning down a position based on the type of company it is? For me…   Read more»

]]> 249cf5e13f078935444913947645f79d https://medicaldevicecourses.com/activity/p/23291/ Sun, 12 Sep 2021 15:13:15 -0400 Posted by: @sahitya-sadineni In my personal opinion, partnerships and sole proprietorship are very similar but with lower risk when investing due to the split of initial costs for partnerships. Partnership sounds amazing for whenever two people share the same objectives…   Read more»

]]> dfc63afb85da126c74e51153f745d78d https://medicaldevicecourses.com/activity/p/23097/ Mon, 30 Aug 2021 14:20:26 -0400 Posted by: @manolo In week one, Dr. Simon went over different aspects of working in Academia vs Industry. He asked us to make an argument for working in either option. As we start going into each role of Medical Device…   Read more»

]]> 4bf7c6ce1af355dd96019d6ab2d234d6 https://medicaldevicecourses.com/activity/p/23096/ Mon, 30 Aug 2021 14:12:57 -0400 Posted by: @bb254 Based on this week’s lecture there are numerous differences on how research is approached in an academia compared to industry. Name two ways that research is approached in academia versus industry. Out of the two approaches which…   Read more»

]]> 71a0d1b6cedaec893707726de0a8d927 https://medicaldevicecourses.com/activity/p/23095/ Mon, 30 Aug 2021 14:04:30 -0400 Posted by: @hm243 In industry, research is done to make discoveries for products that can help people right away, while in academia, research create results for the long run. I feel that both types of research are important and necessary….   Read more»

]]> 9b3794b89f2ebcfc5a730b2cb556739d https://medicaldevicecourses.com/activity/p/23094/ Mon, 30 Aug 2021 14:04:30 -0400 Posted by: @hm243 In industry, research is done to make discoveries for products that can help people right away, while in academia, research create results for the long run. I feel that both types of research are important and necessary….   Read more»

]]> bc6ac9133865def03ec56a9f767b9043 https://medicaldevicecourses.com/activity/p/23093/ Mon, 30 Aug 2021 13:56:08 -0400 Posted by: @sahitya-sadineni Precision and accuracy are very important to the scientific field. Accuracy is how close the value is to a standard while precision refers to how close the values are. What roles do precision and accuracy play into…   Read more»

]]> ada5b6530c51ed97d2831dfbc3eca86c https://medicaldevicecourses.com/activity/p/23092/ Mon, 30 Aug 2021 13:44:13 -0400 Posted by: @hruship101 Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it means to delay product launch or to prevent the…   Read more»

]]> 53ee9d4c8df467ddda021379af06caf5 https://medicaldevicecourses.com/activity/p/23091/ Mon, 30 Aug 2021 13:32:13 -0400 Posted by: @dipanpatel Ethics and Quality are very related; moral attitudes and conscious awareness of standards and guidelines have to be separate from intellectual/company’s agenda. As NJIT student studying ethics and/or professionals in the industry, have you come across ethical…   Read more»

]]> bdf951f10ed8af348a41546de81f9134 https://medicaldevicecourses.com/activity/p/23084/ Sat, 28 Aug 2021 19:30:34 -0400 Posted by: @kak33 Hey everyone, One of the learning objectives for this week was to get an idea of the different jobs available to Biomedical Engineers. In this week’s lecture, Dr. Simon identified a few positions that are available in…   Read more»

]]> aa0ba86019b0597896d90c67ed20d3a4 https://medicaldevicecourses.com/activity/p/23082/ Sat, 28 Aug 2021 19:24:19 -0400 Posted by: @mejefferson The medical device development process requires specific stages to be followed to ensure design control so that the product is both effective and safe for use. As a result, this covers the entire product development cycle, from…   Read more»

]]> e34a0eaada8eeec39c4d29ffd2363f99 https://medicaldevicecourses.com/activity/p/23081/ Sat, 28 Aug 2021 19:11:52 -0400 Posted by: @orleron As I said in the lecture for this module, this course is different. Whereas most courses seek to fill you with academic information in order to create a knowledge base for yourself, this course seeks to lay…   Read more»

]]> 28ddd7c9e39d2c4be29877439586d1d8 https://medicaldevicecourses.com/activity/p/22990/ Mon, 16 Aug 2021 18:02:01 -0400 Posted by: @naglaa-hemida We all start as team members to be a project manager, and it takes time, effort, passion and determination to be a good project manager. However, what are the skills that we should be looking for in…   Read more»

]]> b21f6209f9681913f1fc8c27d98831a3 https://medicaldevicecourses.com/activity/p/22989/ Mon, 16 Aug 2021 15:53:02 -0400 Posted by: @devarshi-joshi The main functions of Human Resource Management department are : 1) Reduce turnover 2)Hire for fit 3)Focus on retention of top performers 5)Improve employee engagement. So my question is how this will help in medical field improving…   Read more»

]]> 133bc81ac037f867f6c9971c281d0810 https://medicaldevicecourses.com/activity/p/22988/ Mon, 16 Aug 2021 15:46:17 -0400 Posted by: @mejefferson From all of the knowledge we have gained throughout PMP, from the basics, to the project life cycle and organizations, to breaking down each process, down to managing a project, do you think you have the potential…   Read more»

]]> ece8776ac9fe233f33ca78e0fd5bce70 https://medicaldevicecourses.com/activity/p/22976/ Sun, 08 Aug 2021 16:58:04 -0400 Based on this course have you gained more interest, less interest, or the same interest in obtaining work as a PM? Personally, before this course, I knew nothing… I have gained more interest in PM jobs! The amount of leadership…   Read more»

]]> 5f7be757f6653eab66b482912f42b256 https://medicaldevicecourses.com/activity/p/22975/ Sun, 08 Aug 2021 16:50:51 -0400 What kind of projects interest you the most ? Why?

]]> a866bf8d46028ec82ea16e9883cf30f0 https://medicaldevicecourses.com/activity/p/22974/ Sun, 08 Aug 2021 16:48:43 -0400 What’s a challenging situation you experienced while working on a project? How did you deal with it? What did you learn?

]]> 7c48247d1c8ce539c616445b8f87be3b https://medicaldevicecourses.com/activity/p/22960/ Sun, 01 Aug 2021 06:54:52 -0400 Posted by: @naglaa-hemida Project cost is a critical aspect of the project, first, the cost plan is the most important part for investors to make sure they are going to make a profit at the end of the project. It…   Read more»

]]> 5922b4c4785740aa292933c1625fca6e https://medicaldevicecourses.com/activity/p/22959/ Sun, 01 Aug 2021 06:01:25 -0400 Posted by: @amin-sadig From as early as the mini sim we were told to consider outside factors such as vacation times for inspectors when planning a schedule so we don’t get delayed unnecessarily. Because the job of a PA is…   Read more»

]]> 2511f28c9bf251cc2e4131a18ceff554 https://medicaldevicecourses.com/activity/p/22958/ Sun, 01 Aug 2021 05:52:06 -0400 Posted by: @djr32 According to the lecture for this week, logging work is important because it can be usefully when new employees come to work on the project or when starting a new project, logs can help as a guidance…   Read more»

]]> 48cfe6a8f458c31392128298fe9a7d9d https://medicaldevicecourses.com/activity/p/22945/ Tue, 27 Jul 2021 14:21:00 -0400 Posted by: @krp76 During the planning phase of a project estimations play a critical role. For medical device projects the cost estimation is not always straightforward as discussed in the lectures. Another estimation that can be misleading is the task…   Read more»

]]> 4086031398bcd8eac08874974216240c https://medicaldevicecourses.com/activity/p/22944/ Tue, 27 Jul 2021 14:10:52 -0400 Posted by: @mejefferson During the planning phase of project management, both time and money are crucial. Timewise, the longer your product takes to develop, the more money you will have to seek from investors yet your product will have a…   Read more»

]]> 3209ca0884a1af73d4d1019c118cb50d https://medicaldevicecourses.com/activity/p/22943/ Tue, 27 Jul 2021 14:06:54 -0400 Posted by: @tn58 Hi Guys, So I know we all have been posting discussion questions regarding simulations and all the lectures each week. However, I wanted to get your input on what you think so far about this course? My…   Read more»

]]> d0f8974a223874aea027089cc0827541 https://medicaldevicecourses.com/activity/p/22924/ Mon, 19 Jul 2021 01:20:26 -0400 Posted by: @jteamer Many different organizational structures take various forms and have various impacts on projects and project management. Based on your own experience, what impact does can an organizational structure have on a project?  One example that comes to…   Read more»

]]> ac1870de47e87e8003f1a83153cf3072 https://medicaldevicecourses.com/activity/p/22923/ Mon, 19 Jul 2021 00:52:03 -0400 How would you handle team conflict as a Project Manager? Often times different views and personalities are placed together on a project. What would be your next steps if your team was falling behind due to conflict? 

]]> f3634a70e8a53b9cf2023fcd1778d8e5 https://medicaldevicecourses.com/activity/p/22922/ Mon, 19 Jul 2021 00:44:40 -0400 Posted by: @arianaburch If you had a business that you newly developed what would be the organizational structure that you would want to run your business with? What are some factors that lead to this choice? What are the advantages…   Read more»

]]> ef4c6f0b13f1200341e31a386094c55a https://medicaldevicecourses.com/activity/p/22908/ Tue, 13 Jul 2021 03:31:58 -0400 Posted by: @rowel2202 When have your organizational skills helped keep a project on track? Does the organizational structure your work in determine how you prioritize the workload? or do you have a set system regardless of leadership ? My organizational…   Read more»

]]> 2b1fc7476a044c3470fc8bec63016a13 https://medicaldevicecourses.com/activity/p/22907/ Tue, 13 Jul 2021 03:17:03 -0400 Posted by: @zcornelius21 What are the advantages of grouping projects under a program? I think that a lot of benefits come from grouping projects together. The first is saving money/ budgeting. This is very important because when you have an…   Read more»

]]> 870b7049b9149a5480052899a2c898f3 https://medicaldevicecourses.com/activity/p/22906/ Tue, 13 Jul 2021 03:09:35 -0400 Posted by: @mejefferson Amongst the three types of organizations discussed in this weeks lecture, functional, project-based, and matrix, all of these have one thing in common which is a chief executive, functional manager, project manager, both, and lastly the staff…   Read more»

]]> f4ede88cf2d2d69fcb3d9f79942802bb https://medicaldevicecourses.com/activity/p/22875/ Mon, 05 Jul 2021 14:47:36 -0400 Posted by: @sallirab Through out the project phases and process communication is the most crucial part. From initiating to the Closing process, if there was no real communication the project will go down. Communication is about what communicators do, we…   Read more»

]]> f775eec3f516922083c0969030690793 https://medicaldevicecourses.com/activity/p/22874/ Mon, 05 Jul 2021 14:32:11 -0400 Posted by: @rgp29 Hello everyone.Project managers need to be effective in a lot of ways. For example, you need to finish the project on time and the quality of the product need to be outstanding. However, they don’t do it…   Read more»

]]> 30bb4da3d4c26d7f9db92d4751791e52 https://medicaldevicecourses.com/activity/p/22873/ Mon, 05 Jul 2021 14:19:40 -0400 Posted by: @jteamer Chapter 2 of the PMBOK highlights the project management offices (PMOs) and the different types of organizations. Out of the three types of PMOs: Supportive, controlling, and directive, which one or ones would you find most suitable…   Read more»

]]> c1b58fa0925a201ce396829a316d16c1 https://medicaldevicecourses.com/activity/p/22846/ Wed, 30 Jun 2021 18:13:17 -0400 Posted by: @srg36 I’m wondering if any of you have experience working on a project where there were multiple project managers who each were responsible for different portions of the project rather than just one project manager who managed the…   Read more»

]]> 3fb84f9acd43f9e59d67b9124b171e1e https://medicaldevicecourses.com/activity/p/22843/ Wed, 30 Jun 2021 12:13:50 -0400 I would say just recently.. working on a group project I was placed with people who had different ideas. Some wanted the presentation one way , while others disagreed and wanted it another way. So the time we wasted arguing…   Read more»

]]> 1988285473baeb96a5048e3c162b88eb https://medicaldevicecourses.com/activity/p/22842/ Wed, 30 Jun 2021 12:07:31 -0400 c2dc487b1e785ddde483d95c070f12e6 https://medicaldevicecourses.com/activity/p/22841/ Wed, 30 Jun 2021 12:05:44 -0400 This is a great question .. and honestly I would say the implementation phase. I picked this as the most important because if you don’t brand right or create something that is useful it will set the tone for the…   Read more»

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