https://medicaldevicecourses.com/members/arianaburch/activity/ Activity feed for arianaburch. Sat, 25 Apr 2026 01:28:35 -0400 https://buddypress.org/?v= en-US 30 hourly 2 b9cf3d89b4c34354e7813d04704b9e6b https://medicaldevicecourses.com/activity/p/23644/ Sat, 09 Oct 2021 17:30:18 -0400 Posted by: @abhitrivedi1211 What factors contribute to determining values for risk index numbers. Two examples are ‘how often the failure occurs’? and ‘what is the severity of the failure?’. Some factors that contribute to determining the values for the risk…   Read more»

]]> 43b3cebb98adcc90d47a768adda0e8af https://medicaldevicecourses.com/activity/p/23643/ Sat, 09 Oct 2021 16:52:59 -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 do believe that once a device maker has weighed the risk-benefits profile extensively…   Read more»

]]> 09f37a6be80994a5a1eadf24b4f7fa1e https://medicaldevicecourses.com/activity/p/23642/ Sat, 09 Oct 2021 16:18:24 -0400 What are some benefits of implementing a risk management assessment for a device? Give the pros and what can be seen as potential cons if there any?

]]> c783d06eecc555e42b3a640af7a77d7f https://medicaldevicecourses.com/activity/p/23545/ Sat, 02 Oct 2021 16:21:22 -0400 Posted by: @fgk4 As we all have learned this week, a validation may not be required if:- There were no changes required to the product after verification.- A clinical trial is not required- Product changes did not affect the user…   Read more»

]]> a1e2925c150755a53780fb785aa020a3 https://medicaldevicecourses.com/activity/p/23544/ Sat, 02 Oct 2021 16:07:14 -0400 Posted by: @la82 As mentioned in other discussions, design control is an integral part of any medical device design, and its benefits are clear. However, what are some of the issues that arise of the process and if it is…   Read more»

]]> 1a5cf88fb7951aa73d9ae4a9964dff1c https://medicaldevicecourses.com/activity/p/23543/ Sat, 02 Oct 2021 15:51:12 -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»

]]> 4706091edb8db9b4387c1eaffbfa0263 https://medicaldevicecourses.com/activity/p/23446/ Sat, 25 Sep 2021 00:53:15 -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»

]]> 055a9811a68a1b73781ecfb2a0137741 https://medicaldevicecourses.com/activity/p/23445/ Fri, 24 Sep 2021 22:25:27 -0400 Posted by: @alexandrabuga Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research.  Lacks was the unknowing…   Read more»

]]> 751290322958cd125eeaf59a389d617b https://medicaldevicecourses.com/activity/p/23440/ Fri, 24 Sep 2021 20:29:26 -0400 Posted by: @llefevre According to the National Institute of Health web site on clinical trials, there are over 225,506 studies currently being conducted throughout the United States and 192 countries. Less than 1% of the total number of studies being…   Read more»

]]> 6cbd36c6ffcebbb421191d2f82f2da3a https://medicaldevicecourses.com/activity/p/23366/ Sat, 18 Sep 2021 12:55:52 -0400 Posted by: @amd29 Prof. Simon has made it simple; he seems to definei) Marketing: — as being able to have the customer believe that what you – the marketing agent – areoffering is what they truly need ii) Sales: —-…   Read more»

]]> 87a30f4b644a55cd78f422bd60ecf656 https://medicaldevicecourses.com/activity/p/23365/ Sat, 18 Sep 2021 12:36:23 -0400 Posted by: @srg36 I have a question about family businesses. Say for example someone started a sole proprietorship, and down the road the business grows and is successful, and that person wants to pass the business on to his 2…   Read more»

]]> ef8d667f69cc05301b0f305ab1aebb56 https://medicaldevicecourses.com/activity/p/23364/ Sat, 18 Sep 2021 12:10:22 -0400 Posted by: @amandaally1029 What is the difference between public and private companies? Based on their differences, what are some pros and cons of each? Give an example of a private and public company, and state the successes. The difference between…   Read more»

]]> 93b610fb983e4588f59bda1f7234d5f6 https://medicaldevicecourses.com/activity/p/23257/ Sat, 11 Sep 2021 02:32:59 -0400 Posted by: @sahitya-sadineni Part of FDA’s mission statement is providing safety and protecting the public health in the use of drugs, medical devices, and etc.. The second part of the mission statement states that they are “advancing the public health…   Read more»

]]> 85ee64820d20ca296f3a3820dbcfa856 https://medicaldevicecourses.com/activity/p/23253/ Sat, 11 Sep 2021 02:11:29 -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»

]]> bbc11e698d482b92fb3e355ebf072c92 https://medicaldevicecourses.com/activity/p/23248/ Sat, 11 Sep 2021 01:21:34 -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»

]]> aae389b2e2cdb8eae3fd11fb4998fd32 https://medicaldevicecourses.com/activity/p/23140/ Sat, 04 Sep 2021 00:29:44 -0400 Posted by: @tulikadasp When it comes to animal research there are various constraints we need to keep in mind. One of them is animal rights. A lot of animal rights group are against this. Recently there are few news about…   Read more»

]]> f5b066caca5af7980d6b94fd298a1438 https://medicaldevicecourses.com/activity/p/23130/ Fri, 03 Sep 2021 22:57:28 -0400 If you had to select right now if you would work Academia or Industry, which would you decide? Their approaches to research are different and yet similar at the same time. Did their approaches to research aid you in your…   Read more»

]]> 3a2e08a29885db185f9facac71216f7c https://medicaldevicecourses.com/activity/p/23124/ Fri, 03 Sep 2021 20:42:46 -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»

]]> 45d7fc21bf6ab48f0b4afedaef9a2c8e https://medicaldevicecourses.com/activity/p/23080/ Fri, 27 Aug 2021 22:16:07 -0400 Posted by: @mduru During the COVID19 pandemic we’ve seen significant shift of resources in many industries. The medical device industry was one of the industries that felt this shift the strongest. Some approvals were fast tracked by regulators while some…   Read more»

]]> 4e1b6da2f927198ab42fee7a02428d3e https://medicaldevicecourses.com/activity/p/23077/ Fri, 27 Aug 2021 01:01:48 -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»

]]> fc5943f19713b4ccdc095276ea343f08 https://medicaldevicecourses.com/activity/p/23076/ Thu, 26 Aug 2021 02:40:39 -0400 Posted by: @orleron We are meeting in an interesting time, to say the least.  As a disease, covid19 has many elements to its treatment and many of those elements use medical devices.  There are ventilators and syringes, which we all…   Read more»

]]> 685cee2b13a69ee2e6d4eeaeb16c9e13 https://medicaldevicecourses.com/activity/p/22996/ Thu, 19 Aug 2021 02:59:45 -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»

]]> 8ad7c2540c70fa037e1207ecfa4c0ded https://medicaldevicecourses.com/activity/p/22995/ Thu, 19 Aug 2021 02:43:03 -0400 Posted by: @aasutosh-purohit In the lecture we studied about Quality Assurance and Quality control. How these both are different from each other? Quality Assurance is the maintenance of a service or product. This would require for all planned activities to…   Read more»

]]> 9a4c0d51e5ebda0d6ce05932986ef595 https://medicaldevicecourses.com/activity/p/22994/ Thu, 19 Aug 2021 01:52:48 -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»

]]> 45e6aaf3f425cb67a094471eb54b95cc https://medicaldevicecourses.com/activity/p/22984/ Thu, 12 Aug 2021 01:32:19 -0400 Is there a processes/phase that you would consider to be more important? Or are they all just as equally important? 

]]> d64140528f5166c15f707cd2df57c948 https://medicaldevicecourses.com/activity/p/22983/ Thu, 12 Aug 2021 00:58:09 -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»

]]> deebb43c8d1dff7665639141edbe01c5 https://medicaldevicecourses.com/activity/p/22982/ Thu, 12 Aug 2021 00:20:06 -0400 Posted by: @arianaburch In the Executing process how would you deal with a members needing to take vacations and or some other obligations that have come up and still ensure that the project that is being worked on deadlines are…   Read more»

]]> 98a8363cc9f97cb8c6db2c899d926ef6 https://medicaldevicecourses.com/activity/p/22969/ Thu, 05 Aug 2021 03:06:13 -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»

]]> 6854cbbc7b482d8d45c3c3f6048eccf1 https://medicaldevicecourses.com/activity/p/22968/ Thu, 05 Aug 2021 02:11:24 -0400 Posted by: @ap962 This weeks lecture talks about project planning and execution. As a Project Manager, what are the key factors that need to be taken into consideration for a successful project execution?Also, what factors you would as a Manager…   Read more»

]]> 2227570ec6bcae31ab2a1d7e8cba44b8 https://medicaldevicecourses.com/activity/p/22967/ Thu, 05 Aug 2021 01:24:25 -0400 In the Executing process how would you deal with a members needing to take vacations and or some other obligations that have come up and still ensure that the project that is being worked on deadlines are not missed in…   Read more»

]]> 2917bc31ed263b6758fab5895cfdacb6 https://medicaldevicecourses.com/activity/p/22951/ Thu, 29 Jul 2021 01:30:48 -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»

]]> eb27c0507e9c791f56d0c97800fc8931 https://medicaldevicecourses.com/activity/p/22950/ Thu, 29 Jul 2021 01:11:10 -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»

]]> b32d884be6537fb9ffb1622ef925764f https://medicaldevicecourses.com/activity/p/22949/ Thu, 29 Jul 2021 00:47:22 -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»

]]> b3b2d6cc86035c351db48a746652ca50 https://medicaldevicecourses.com/activity/p/22936/ Thu, 22 Jul 2021 01:29:25 -0400 Posted by: @devarshi-joshi According to me the most important 5 success factors are:1)Agreeing on the project goals2)Effective Communication3)Develop clearly defined plans with assigned responsibilities.4)Managing project scope effectively.5)Making sure of management support. So how are these factors individually important for a…   Read more»

]]> 80193e163d995823692fb692c21cb9f1 https://medicaldevicecourses.com/activity/p/22935/ Thu, 22 Jul 2021 00:58:03 -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»

]]> 0239682c18a36d2e609818cf0f0c82fb https://medicaldevicecourses.com/activity/p/22933/ Thu, 22 Jul 2021 00:05:48 -0400 Posted by: @ap962 The end of the Monitoring and Controlling Phase is marked by the Closing Phase. What are steps that need to be followed to ensure that phase is carried out effectively? Since the monitoring and controlling phase is…   Read more»

]]> 637b9ed92cfe0b55f2e690496801faff https://medicaldevicecourses.com/activity/p/22917/ Wed, 14 Jul 2021 23:27:32 -0400 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 to the organizational…   Read more»

]]> 32e52825b8adbf7161adf92eec3e4fc1 https://medicaldevicecourses.com/activity/p/22916/ Wed, 14 Jul 2021 22:58:29 -0400 Posted by: @zcornelius21 What are the advantages of grouping projects under a program? The advantages of grouping projects under a program would be that the you can break the parts  up and are able to work together collectively. Everyone would…   Read more»

]]> e686f6bb0579c48397e839eda34933d4 https://medicaldevicecourses.com/activity/p/22915/ Wed, 14 Jul 2021 22:26:12 -0400 Posted by: @limalo What do you think is the difference between a project manager and a clinical project manager The difference between a project manager and a clinical project manager is that a project manager is the individual that in…   Read more»

]]> d25d0610abb4a952f93438b9347a6d36 https://medicaldevicecourses.com/activity/p/22892/ Thu, 08 Jul 2021 00:15:11 -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»

]]> 19c774d12b0933098f66fbf708fc7f06 https://medicaldevicecourses.com/activity/p/22891/ Wed, 07 Jul 2021 22:15:34 -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»

]]> 8ea66435ca4b52a6f794624aa090a3e0 https://medicaldevicecourses.com/activity/p/22890/ Wed, 07 Jul 2021 21:29:52 -0400 Posted by: @zcornelius21 What competencies are important for a project manager to possess? Hello Zipporrah great question. Competencies that are important for a project manager to possess and just to name a few are to be able to execute a…   Read more»

]]> 2db9f0a6dfd9cff80d0020e2cbba178d https://medicaldevicecourses.com/activity/p/22857/ Thu, 01 Jul 2021 02:58:42 -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 ? Yes my…   Read more»

]]> 59a50aa1a74921df653c45df1e4d3fdc https://medicaldevicecourses.com/activity/p/22855/ Wed, 30 Jun 2021 22:36:08 -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»

]]> 5499433e49b820ef43b828077ca99ac8 https://medicaldevicecourses.com/activity/p/22854/ Wed, 30 Jun 2021 21:40:12 -0400 Posted by: @kbentleymsm-edu Consider the three types of organizations in project management: functional, project-based, and matrix.  Which of those formats do you think you would most like to work under?  Explain.   Hello great question. Considering the three types of…   Read more»

]]> 6492bfea72922a95d8e1a2031bd99f2c https://medicaldevicecourses.com/activity/p/22834/ Wed, 30 Jun 2021 03:28:50 -0400 0