https://medicaldevicecourses.com/members/jteamer/activity/ Activity feed for jteamer. Fri, 24 Apr 2026 18:41:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 23c6b73954cba459d8ce5ca8505716da https://medicaldevicecourses.com/activity/p/22772/ Fri, 25 Jun 2021 02:27:56 -0400 Posted by: @as934 While consultants can provide many different areas of expertise, the consultants that I have come across during my career in the medical device industry have mostly been experts in regulatory compliance. Companies may hire compliance consultants to…   Read more»

]]> 8a407f7ca7b0ab47cdf34b9990ded421 https://medicaldevicecourses.com/activity/p/22771/ Fri, 25 Jun 2021 02:24:07 -0400 Posted by: @rgp29 Hello everyone, As I was listening to this week’s lecture, it called my attention the fact that companies can only give gifts of 100$ to the physicians and those gifts have to be related to health. Additionally,…   Read more»

]]> ef2ff737244b2c8c9b8f0ddf5df5384d https://medicaldevicecourses.com/activity/p/22770/ Fri, 25 Jun 2021 02:08:48 -0400 Posted by: @fo3 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project according to their expertise/role. How would…   Read more»

]]> 947406a2ff69c3c3f7f641e4d263684d https://medicaldevicecourses.com/activity/p/22685/ Wed, 16 Jun 2021 03:23:12 -0400 Posted by: @hg93 Risk management is the process of analyzing, identifying and responding to risk factors throughout the course of the project. Managing risks early on in the project is the best way to avoid project catastrophes. Continuously applying the…   Read more»

]]> fe6a2d6d29185228e61ffbfc36c191ea https://medicaldevicecourses.com/activity/p/22684/ Wed, 16 Jun 2021 03:05:53 -0400 Posted by: @smk45 I came across an article online that highlights 4 reasons why a company’s risk management approach may be wrong. It was an interesting read and indicates the following as major errors: 1. Risk management and design controls…   Read more»

]]> 82b9330ac1de02517636037412dbcf0a https://medicaldevicecourses.com/activity/p/22683/ Wed, 16 Jun 2021 03:00:31 -0400 A risk management file accumulates all the records, files/documents, and activity logs pertaining to risk management. According to greenlight guru, a risk management file can include all of the following: Risk Management Plan Risk Analysis Risk Evaluation Risk Controls Evaluation…   Read more»

]]> 1e417328962d385c78723dfea1123777 https://medicaldevicecourses.com/activity/p/22648/ Tue, 08 Jun 2021 23:17:36 -0400 Posted by: @rgp29 Hello everyone, I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Before this, when I was…   Read more»

]]> f157226377bce6eb61a6d44c6e4641fe https://medicaldevicecourses.com/activity/p/22647/ Tue, 08 Jun 2021 23:13:37 -0400 In response to prevent so many recalls of medical devices and other medical products, the FDA envokes design controls regulations. Design controls are a set of policies and procedures implemented to standardized quality checks points of medical devices. They control…   Read more»

]]> e5c88d5f38797ec65794c10eac3f32b3 https://medicaldevicecourses.com/activity/p/22646/ Tue, 08 Jun 2021 23:12:15 -0400 Design controls are a set of policies and procedures implemented to standardized quality checks points of medical devices. They control the design process to ensure that a medical device meets specific requirements that are helpful to the consumer. In general,…   Read more»

]]> b0566a690209a89f40f47d44193124d3 https://medicaldevicecourses.com/activity/p/22612/ Mon, 07 Jun 2021 00:55:17 -0400 Posted by: @orleron As you interact with the CRA profession, you will notice a heavy preference for people with a “clinical background”. This means people who have been or are nurses, doctors, or other kinds of technical workers who interact…   Read more»

]]> 1cfb55070209f23610e859b0b8475701 https://medicaldevicecourses.com/activity/p/22611/ Mon, 07 Jun 2021 00:51:50 -0400 Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake…   Read more»

]]> e60af7faac5b056844ca6e4cb5faca30 https://medicaldevicecourses.com/activity/p/22610/ Mon, 07 Jun 2021 00:37:51 -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»

]]> 3cc78318a9e6ebbe471385d78891e353 https://medicaldevicecourses.com/activity/p/22575/ Mon, 31 May 2021 02:38:02 -0400 Posted by: @manolo Dr. Simon touched upon Branding when going over the Facets of Marketing. The coloring is an important component to think about when branding a product/company. What kind of coloring do you notice companies are using and why…   Read more»

]]> 57bc4abf104471dc4439637e019f37b0 https://medicaldevicecourses.com/activity/p/22574/ Mon, 31 May 2021 02:34:13 -0400 @as934 The use of social media to create an interactive platform is increasingly becoming common practice to utilize social media for marketing and increase possible consumers’ participation. Especially more prevalent with quarantine and COVID restrictions. I have not personally seen…   Read more»

]]> d4270d7e8a78f6cc31c63fed1c219707 https://medicaldevicecourses.com/activity/p/22573/ Mon, 31 May 2021 02:32:06 -0400 Posted by: @orleron Remember “The Four Ps of Marketing”: product, price, promotion, and placement. Product:What are you selling & why?Price:How much does the product cost? When does the price change?Promotion:How will you promote the product? Viral marketing? Internet Advertising?Placement:Who sells…   Read more»

]]> fb4d56825123835b613653f3039a48ef https://medicaldevicecourses.com/activity/p/22529/ Mon, 24 May 2021 02:41:18 -0400 Posted by: @orleron This is always a fun module for discussion topics because there’s always some modern technology out there that challenges the current regulatory framework. Today… e-cigarettes. If you don’t know what one is, google it. Does the FDA…   Read more»

]]> 3a1fc6de02a0c5f17afff3bf38c4998f https://medicaldevicecourses.com/activity/p/22528/ Mon, 24 May 2021 02:35:56 -0400 @jafar When I thought about this question I immediately thought about the difference in drug regulation between the US and India. The US is known for having one of the most organized and regulated drugs governing bodies while India is…   Read more»

]]> 9274001ab216d1f21eb43420b5f6892a https://medicaldevicecourses.com/activity/p/22527/ Mon, 24 May 2021 02:11:40 -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»

]]> 603ee2236f7ba8416c9cc20b96563651 https://medicaldevicecourses.com/activity/p/22526/ Mon, 24 May 2021 02:11:22 -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»

]]> 2201ae4549da7cc64028868fc13a11aa https://medicaldevicecourses.com/activity/p/22492/ Mon, 17 May 2021 03:10:43 -0400 Posted by: @mrlee5 There are scientists who are developing and using animal-free methods that are actually shown to be relevant to human health for studying diseases and testing products. There is a variety of cell-based tests and tissue models that…   Read more»

]]> 134c9251e9b99adc4952f5ec23a4d2f1 https://medicaldevicecourses.com/activity/p/22491/ Mon, 17 May 2021 03:06:38 -0400 Posted by: @carrissap10 Being that I am a dog owner of two amazing Pitbull’s, I believe that there could be another way to experiment with animals. The animal testing should not have to require an animal losing their life. There…   Read more»

]]> a847ba2a09e92a004b2e17d67399fab5 https://medicaldevicecourses.com/activity/p/22490/ Mon, 17 May 2021 03:02:54 -0400 Posted by: @sahitya-sadineni Although science has been around for a while, technology is something that has been evolving in the past 20 years. Pre-clinical is very important to every and any kind of medical research. But what is also important…   Read more»

]]> d44ecf3c7201ccc576acef9775961c95 https://medicaldevicecourses.com/activity/p/22489/ Mon, 17 May 2021 03:02:03 -0400 Posted by: @sahitya-sadineni Although science has been around for a while, technology is something that has been evolving in the past 20 years. Pre-clinical is very important to every and any kind of medical research. But what is also important…   Read more»

]]> fe6070142a1df23e7a0dadc629cc359d https://medicaldevicecourses.com/activity/p/22412/ Thu, 06 May 2021 00:13:51 -0400 Posted by: @karen-immanuel Hello all, I was just curious as to what level of education is best before getting into industry. My thoughts are that BS is good enough to employ you with basic skills and knowledge. Later, you can…   Read more»

]]> f5cfb4abafb1bf1d480be01cedfcba7e https://medicaldevicecourses.com/activity/p/22411/ Thu, 06 May 2021 00:01:19 -0400 Posted by: @orleron This week is an overall introduction to the field of medical device development. We take some time to pay attention to the differences between Academia and Industry (Commercial) because students in this course may come from one…   Read more»

]]> 6bf42cd4c1c2c3e81ba1241633be5d3b https://medicaldevicecourses.com/activity/p/22410/ Wed, 05 May 2021 23:56:14 -0400 Posted by: @maniakberk So a Project Manager(PM) position is something I wanted to have over the years but I was never accepted to any of my applications as an employee. So my question is that what a person can do…   Read more»

]]> fea49360c5d958be5945b421e636abec https://medicaldevicecourses.com/activity/p/22409/ Wed, 05 May 2021 23:31:08 -0400 Posted by: @maniakberk So a Project Manager(PM) position is something I wanted to have over the years but I was never accepted to any of my applications as an employee. So my question is that what a person can do…   Read more»

]]> 3d13e0be3983477364f49691d3909242 https://medicaldevicecourses.com/activity/p/22248/ Fri, 23 Apr 2021 02:32:33 -0400 Posted by: @hiren-rana One of the topics that we learned this week is Procurement Management. What this entails is essentially handling processes that require goods and services from an outside organization via raw materials, services, etc. Ideally, you want to…   Read more»

]]> b4fe74e6042d6dfc8aa36a6affe8c188 https://medicaldevicecourses.com/activity/p/22247/ Fri, 23 Apr 2021 02:09:49 -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»

]]> e2fd3e195417780eb09f8b59ba3f10a4 https://medicaldevicecourses.com/activity/p/22246/ Fri, 23 Apr 2021 02:01:42 -0400 Posted by: @krp67 Communication Management seems like a trivial knowledge area however, its seems as though it needs to be implemented in a PM. This topic of communication is critical. Lack of communication is why we have so many issues…   Read more»

]]> 15e96db1bd0c5efa8e7c8d6ba52cac25 https://medicaldevicecourses.com/activity/p/22101/ Tue, 13 Apr 2021 05:13:53 -0400 Posted by: @bb254 There are numerous monitoring and controlling techniques which were mentioned in this week’s lecture. Which technique do you believe is the most essential in this phase of the design control and explain why? If you know any…   Read more»

]]> 81abee6a28e58e9f2d20455df5418b5a https://medicaldevicecourses.com/activity/p/22100/ Tue, 13 Apr 2021 05:07:59 -0400 Posted by: @naglaa-hemida When working on a project missing a milestone is a possibility, due to technical issues, environmental causes, or human errors. what are some ways to overcome and get back on track after missing a milestone? Missing milestones…   Read more»

]]> 315d89da72040b5b0aceb4a91cb1c8d5 https://medicaldevicecourses.com/activity/p/22099/ Tue, 13 Apr 2021 05:02:32 -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? The closing phase is the final phase…   Read more»

]]> a50b5cae93178d13aea0bf21f3e800bb https://medicaldevicecourses.com/activity/p/22088/ Mon, 12 Apr 2021 04:02:43 -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»

]]> 610974c0501cbff44e58e73341dc8bbe https://medicaldevicecourses.com/activity/p/22087/ Mon, 12 Apr 2021 03:58:30 -0400 Posted by: @naglaa-hemida From the point of initiating an idea to be a project to the point we get this project to the manufacturing stage, project passes by many stages, millstones and research that can lead to failure. Poor choice…   Read more»

]]> b9edb71099eeb5ab66dfd1c401ecacf3 https://medicaldevicecourses.com/activity/p/22024/ Thu, 08 Apr 2021 08:13:20 -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»

]]> faebdc4ddaf7044662e6b076006f19be https://medicaldevicecourses.com/activity/p/21977/ Mon, 05 Apr 2021 00:48:46 -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»

]]> 30f332d20b30e4c64ed2eed9c2c15389 https://medicaldevicecourses.com/activity/p/21976/ Mon, 05 Apr 2021 00:43:22 -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»

]]> 359ae95c2ea2d45d8a9baba9f5e3ad76 https://medicaldevicecourses.com/activity/p/21953/ Thu, 01 Apr 2021 22:15:19 -0400 Logging in work and keeping adequate records is important in just about every discipline, but it is essential in project management. Taking project notes and reconciling data will help make future processes more efficient. By logging your work, you can…   Read more»

]]> c2f56b2cae25d11f2969d204fd177439 https://medicaldevicecourses.com/activity/p/21871/ Fri, 26 Mar 2021 20:11:11 -0400 Posted by: @rjs84 Part of the executing process involves information distribution, solicitation, source selection, and managing vendor relations. Most of the time and money of the project go into its execution. I would argue that the parts of the executing…   Read more»

]]> 12911f92b3644b90e2ec61ab9a14b0e1 https://medicaldevicecourses.com/activity/p/21870/ Fri, 26 Mar 2021 20:04:45 -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»

]]> 50cc333d5e99b726fda13bf547a55309 https://medicaldevicecourses.com/activity/p/21869/ Fri, 26 Mar 2021 19:49:53 -0400 Posted by: @naglaa-hemida From the point of initiating an idea to be a project to the point we get this project to the manufacturing stage, project passes by many stages, millstones and research that can lead to failure. Poor choice…   Read more»

]]> 9924a9a09d1eb3f3d76518c41c41963f https://medicaldevicecourses.com/activity/p/21820/ Sun, 21 Mar 2021 08:30:22 -0400 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 to your project…   Read more»

]]> 18145921f5084e43bc6f75b61dd4c144 https://medicaldevicecourses.com/activity/p/21819/ Sun, 21 Mar 2021 08:20:09 -0400 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 mind for me…   Read more»

]]> b30daaae10b6c6cc12f789a4a1056bcc https://medicaldevicecourses.com/activity/p/21818/ Sun, 21 Mar 2021 08:10:35 -0400 There are always going to roadblocks that arise during project management. Sometimes these problems are within one’s control, and sometimes they are caused by external factors; enterprise environmental factors (EEFS) are some of these influencing obstacles. EEFS can be external…   Read more»

]]> 91651e5730deef21de3e5bb4ac944e93 https://medicaldevicecourses.com/activity/p/21643/ Fri, 12 Mar 2021 06:33:27 -0500 Most of my project management experience has been from an administrative standpoint. In a sense, I function as the right-hand man for many people who lead projects and programs, but I wouldn’t consider myself directly involved. I handle many of…   Read more»

]]> 0d36622a00a972a292857662d189849d https://medicaldevicecourses.com/activity/p/21642/ Fri, 12 Mar 2021 06:03:49 -0500   IF YOU WANT TO GO FAST GO ALONE IF YOU WANT TO GO FAR GO TOGETHER – African proverb. Generally speaking, if I had to create my dream or ideal project team, I would want to create a highly…   Read more»

]]> 16bed8c65570fac04c32e7869f81c2d0 https://medicaldevicecourses.com/activity/p/21641/ Fri, 12 Mar 2021 05:44:21 -0500 A few things come to mind that a project manager can use to ensure mistakes are not made. First, taking the time to understand the project’s full scope would prevent many mistakes early on. Often, if the project’s scope is…   Read more»

]]> b4fa95560d46f81a1ea5e6d6ee82f6bb https://medicaldevicecourses.com/activity/p/21542/ Sun, 07 Mar 2021 20:59:09 -0500 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»

]]> 0254dca837c24dcae29909e3629e4037 https://medicaldevicecourses.com/activity/p/21541/ Sun, 07 Mar 2021 20:47:05 -0500 Almost any decision we make is based on logic, emotions, or a combination of the two. With that being said, when it comes to making business-related decisions, say in the scope of project management or leadership, it is essential to…   Read more»

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