https://medicaldevicecourses.com/members/eowinomsm-edu/activity/ Activity feed for eowino. Fri, 24 Apr 2026 21:48:21 -0400 https://buddypress.org/?v= en-US 30 hourly 2 c41ac7cd6438a7d860b2d860ec61fa67 https://medicaldevicecourses.com/activity/p/22826/ Mon, 28 Jun 2021 18:07:27 -0400 It provides great insights into your business and in the broader marketplace. Market research can identify how customers and potential customers might view your business and identify gaps in customer expectations.

]]> 60a0655ac1e6b8534ac7b9c6fecffc91 https://medicaldevicecourses.com/activity/p/22825/ Mon, 28 Jun 2021 17:46:39 -0400 The first device I know of was CPAP Continuous Positive Airway Pressure, The most effective treatment for obstructive sleep apnea; CPAP blows air with continuous pressure down your throat at night to keep your airways open while you. I heard of this device from…   Read more»

]]> bb3e0081f139d8c8c4a5e62961a39bf6 https://medicaldevicecourses.com/activity/p/22824/ Mon, 28 Jun 2021 15:25:14 -0400 The Form 483s are available under the Freedom of Information Act but may be redacted to remove non-public information. The FDA usually publishes select 483s on their website at this location: ORA FOIA Electronic Reading Room; you can find of recently issued 483s are…   Read more»

]]> fa160ab53ead4c752f01c3baa757f1ee https://medicaldevicecourses.com/activity/p/22823/ Mon, 28 Jun 2021 09:23:56 -0400 Risk Register Using Risk Register can be effective this is a living document which is updated frequently throughout the life cycle of the project. It will become a part of project documents and is always included in the historical records…   Read more»

]]> 2e742253de2c1828a8db70e45eead38d https://medicaldevicecourses.com/activity/p/22822/ Mon, 28 Jun 2021 09:19:43 -0400 The process of putting a strategic plan of managing identified threats and exploiting opportunities into action is called the implementation of the risk management plan. Such a process may take many forms. What methods and tools you are going to choose…   Read more»

]]> ba4a1b30cf3d29afc418daf2d4a330e4 https://medicaldevicecourses.com/activity/p/22821/ Mon, 28 Jun 2021 09:13:17 -0400 There are numerous ways to identify risks, such as brainstorming, the Delphi Technique, Pre-mortem, and the Cause and Effect Diagram. Depending on the nature of your project, project managers may use two or more of these methods during a project….   Read more»

]]> bbc1f284b06b1729d834d0794881c8ec https://medicaldevicecourses.com/activity/p/22820/ Mon, 28 Jun 2021 07:44:43 -0400 “The False Claims Act offers whistleblowers an effective way to expose and stop pharmaceutical and medical kickbacks in the healthcare system. Kickbacks – hidden financial arrangements between doctors and hospitals or other healthcare providers or companies – are one of…   Read more»

]]> 6ac70f133c90d42135bc0a80b3bf1387 https://medicaldevicecourses.com/activity/p/22819/ Mon, 28 Jun 2021 07:36:40 -0400 One of the major issues with Maslow’s hierarchy of needs theory is that it cannot be tested empirically. There is no way to measure precisely how satisfied one level of need must be before the next higher need becomes operative….   Read more»

]]> a4848fdd026b67305aa6d02f8dfd4434 https://medicaldevicecourses.com/activity/p/22818/ Mon, 28 Jun 2021 07:26:24 -0400 I do not believe that it’s too restrictive. I believe these rules were set for a reason. A line has to be drawn somewhere; otherwise, people will always push the boundaries. So it makes sense to make it restrictive so…   Read more»

]]> 70e6857eef6eab3c1138a9a98c41074d https://medicaldevicecourses.com/activity/p/22639/ Mon, 07 Jun 2021 18:06:20 -0400 A nonprofit organization is one that qualifies for tax-exempt status by the IRS because its mission and purpose are to further a social cause and provide a public   benefit. Nonprofit organizations include hospitals, universities, national charities and foundations in a market driven my profits…   Read more»

]]> 17b26e2b3e85605febd691fbfbdcad0f https://medicaldevicecourses.com/activity/p/22625/ Mon, 07 Jun 2021 05:16:37 -0400 As Dr. Simon discussed in the lecture the mind is a powerful thing and sometimes just believing something is work. I think the placebos are important because it helps scientists by contributing to their research. I believe as long as…   Read more»

]]> d41462e94bea68917da64c92524e46d5 https://medicaldevicecourses.com/activity/p/22622/ Mon, 07 Jun 2021 05:04:42 -0400 Informed consent originates from the patient’s right to direct what happens to their body, even though Henrietta Lacks cells have gone on to contribute greatly to science and make a lot of people rich. I still believe ethically that everybody…   Read more»

]]> c9ebacde512cf108f8b394fb1a0acf76 https://medicaldevicecourses.com/activity/p/22621/ Mon, 07 Jun 2021 04:55:02 -0400 The Right to Try Act, was signed into law May 30, 2018. This law gave patients another way to access treatments that have not been approved yet the patients that are eligible have been diagnosed with life-threatening diseases or conditions…   Read more»

]]> 98a972309addb1fb75b962d6e418ae75 https://medicaldevicecourses.com/activity/p/22538/ Mon, 24 May 2021 06:11:04 -0400 It’s very easy to confuse the two aspects the first Quality control can be defined as “part of quality management focused on fulfilling quality requirements.” While quality assurance relates to how a process is performed or how a product is made, quality control is more the…   Read more»

]]> 712315e499c1711a2dafe14851d064bd https://medicaldevicecourses.com/activity/p/22536/ Mon, 24 May 2021 05:42:38 -0400 What is the relationship between FDA’s Quality System Regulation forDevices, Part 820, and ISO 9001:2000?

]]> d4e70a4b6366a9ea68e05dfb64c3ec2d https://medicaldevicecourses.com/activity/p/22531/ Mon, 24 May 2021 03:48:47 -0400 R&D mainly focuses on being able to advance technology to develop a better products for a company while the area of quality makes sure that the product being made will be safe. In the end both sections value the making…   Read more»

]]> 0fc2fe2fbc0230dbbd16016ad105c71b https://medicaldevicecourses.com/activity/p/22508/ Fri, 21 May 2021 17:03:55 -0400 Academia research mainly focused is on research and discovery the love of science and learning. However, we see that it is different in industry work that allows their researchers to feel a sense of immediate impact on patient lives by…   Read more»

]]> bfb066cf3894e393bcbe99b3d210401f https://medicaldevicecourses.com/activity/p/22447/ Mon, 10 May 2021 04:06:43 -0400 Currently, the FDA has three medical device classifications and reporting requirements that have become increasingly stringent. 

]]> 4dc3c32d035a6f8d686ee47aa2f062eb https://medicaldevicecourses.com/activity/p/22446/ Mon, 10 May 2021 04:00:06 -0400 Concerning devices, controlled studies of devices can be difficult since outcomes can depend on how they will be used, for example, in surgical procedures, which may vary. The device risks may also be long-term, but many studies do not report…   Read more»

]]> 6cee43f7d01926fd9160ed48bffe94c2 https://medicaldevicecourses.com/activity/p/22445/ Mon, 10 May 2021 03:54:07 -0400 Posted by: @akshayakirithy I would like to work in R&D department of any medical industry. Research is the place where you explore and get new ideas. You can put yourself in to the world of your own creations.Currently I feel…   Read more»

]]> 100fef00cbf08173e9e20900348e26ca https://medicaldevicecourses.com/activity/p/22316/ Mon, 26 Apr 2021 06:23:43 -0400 The project manager also has to manage the execution of the project communication management plan. The following communication management skills can also increase a project manager’s chances of success: Have robust and active listening skills Have Proficient writing skills Have…   Read more»

]]> 8655cb1ed22d10325217b8c53457e957 https://medicaldevicecourses.com/activity/p/22315/ Mon, 26 Apr 2021 06:08:54 -0400 Posted by: @sromemsm-edu In this case, I would choose multiple vendors regardless of the extra time that it may take. This is similar to creating a management plan but not having a backup plan when things go astray. Taking the…   Read more»

]]> 17f23b6b7cbd53fb19337a22bc35f616 https://medicaldevicecourses.com/activity/p/22311/ Mon, 26 Apr 2021 04:18:25 -0400 Know which vendor contracts affect your work. Identify a direct contact for each vendor. The important things to look for in vendor contracts are extensions and adjustments in timelines. A flexible vendor with changes in time and structures within a…   Read more»

]]> 7536f4b47bbfaa5726f9337d3ea833db https://medicaldevicecourses.com/activity/p/22194/ Mon, 19 Apr 2021 03:55:38 -0400 You may have people assigned to the project who are lacking some critical skills. Meet with the individuals that are responsible for the slipping tasks. See where they stand on this: Do they need help, or is something else going…   Read more»

]]> 7d2cfec815632eca2096db4ec50131a6 https://medicaldevicecourses.com/activity/p/22191/ Mon, 19 Apr 2021 03:41:08 -0400 A project will be considered a failure when it does not deliver what was required within the agreed-upon budget and time frame. In most cases, the stakeholders decide if the project was a success or a failure based on their…   Read more»

]]> 536e5466f4d43af5a3067f8d46a74aee https://medicaldevicecourses.com/activity/p/22174/ Mon, 19 Apr 2021 02:10:51 -0400 In project management, the closing phase is the final phase of the project lifecycle. All deliverables are finalized and formally transferred during this stage, and all documentation will be signed off, approved, and archived. The closing phase is when everything…   Read more»

]]> 3c36256094457550040060611036d754 https://medicaldevicecourses.com/activity/p/22141/ Fri, 16 Apr 2021 21:41:51 -0400 8ec66f9a33027ed5d131ecaa8e9e25f8 https://medicaldevicecourses.com/activity/p/22089/ Mon, 12 Apr 2021 04:59:01 -0400 3b9857287a52ad7ffbef41d34f5b52d0 https://medicaldevicecourses.com/activity/p/22064/ Mon, 12 Apr 2021 01:16:18 -0400 This course has provided me with additional knowledge, skills, techniques, and tools to successfully manage or deliver projects and programs.  I believe a potential employer is looking to have people who have these skills to enhance excellent communication and decision-making…   Read more»

]]> c56d8e8a52ab4d60e91634d89cc33d7c https://medicaldevicecourses.com/activity/p/22061/ Mon, 12 Apr 2021 00:52:10 -0400 Gantt Chart is essential because it helps drill down activities that need to be done by a specific time. It is usually used to track project schedules. You will find that tasks are shown on the vertical axis in the Gantt…   Read more»

]]> 58fd5d87d40944ead0b997774a36b08c https://medicaldevicecourses.com/activity/p/22058/ Mon, 12 Apr 2021 00:41:29 -0400 @ks629 I agree that knowing the team members’ different personality types and communicating with them is very important to have everyone on the same page. Communicating with everyone to work cohesively is very important. This will avoid miscommunication and people…   Read more»

]]> 6d2fdde226121312f9f4c597b24a6590 https://medicaldevicecourses.com/activity/p/21992/ Mon, 05 Apr 2021 04:53:06 -0400 During a project, we set milestones to achieve. It can be unavoidable to miss these milestones. Different things can come into play that can cause a team not to meet the deadline; missing a milestone can be a failure by the group or ensure that…   Read more»

]]> 8c3997632366163069f887595164d5c4 https://medicaldevicecourses.com/activity/p/21991/ Mon, 05 Apr 2021 04:40:04 -0400 The budget will determine critical decision points such as the design used. The team that will develop and deliver the project end-to-end or helps with a few elements or who work for a smaller budget. The size of the project?…   Read more»

]]> df4dfddaccc5f31e1da91b326c384580 https://medicaldevicecourses.com/activity/p/21989/ Mon, 05 Apr 2021 04:29:42 -0400 Unexpected time delays in a project can be due to many factors  Budget Inaccuracies Labor Challenges Approvals Subcontractor Schedules and Compliance Lack of Effective Communication Poor Weather The list can be endless Predictable delays can be factored into the project through a…   Read more»

]]> c9eb0bc00c3052a35300e09907ea2e68 https://medicaldevicecourses.com/activity/p/21939/ Mon, 29 Mar 2021 04:07:17 -0400 Logging work is essential, and it is key to understanding how much every person of a project is getting done. It is key to productivity, insight, and a healthy workflow. When dealing with different deadlines and different project cycles, you…   Read more»

]]> b2d27fb54cda38a3ac35ac48ecd79bdd https://medicaldevicecourses.com/activity/p/21938/ Mon, 29 Mar 2021 03:59:39 -0400 The cycle begins when a product or idea comes together. Within Every stage, a project’s process may have its risks and challenges, so being able to manage the risk at each stage, the chances that come with the specific project…   Read more»

]]> 72caf6ea9bb98a6d037b12fa659d4274 https://medicaldevicecourses.com/activity/p/21839/ Mon, 22 Mar 2021 05:49:44 -0400 I believe that the effect that organizational structures have on project management is that they change the way different projects are executed and structured. This is because the different organizational structures do the thing in different ways, projects would be…   Read more»

]]> 2c5cc452148844565fbc1d5f8f3d3f55 https://medicaldevicecourses.com/activity/p/21838/ Mon, 22 Mar 2021 05:24:29 -0400 Yes, organizational structures do change the way I prioritize. depending on how the organization is structured. You will have to change the way you do things. Having set priorities and decision-making involve a different set of skills and being able…   Read more»

]]> f10183ecbce62871bbcc9a125400f96b https://medicaldevicecourses.com/activity/p/21792/ Mon, 15 Mar 2021 05:08:56 -0400 When discussing Organizational Behavior I think the management model’s always set us in the right direction. I also believe the best organizational model is a supportive model; this is a framework for thinking about organizational behavior. It is built on leadership,…   Read more»

]]> 10f89c3e00234ef6d11b9ca7b89cc76e https://medicaldevicecourses.com/activity/p/21791/ Mon, 15 Mar 2021 04:51:13 -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»

]]> c2431de77a29c9909bdbb037867ee782 https://medicaldevicecourses.com/activity/p/21788/ Mon, 15 Mar 2021 04:28:37 -0400 @kc4310 Hey Kc you bring up some great questions, I also agree that it makes sense that there ate different centers.

]]> 6aaa6f2a0c02ffd0171578feb475cd55 https://medicaldevicecourses.com/activity/p/21787/ Mon, 15 Mar 2021 04:25:39 -0400 This week it was interesting to learn about the FDA regulations on medical devices and the different classifications Class I, II, and III. There are layers of regulatory control, and they increase from Class I to Class III. The device…   Read more»

]]> bf454e5c44014c6261a3d72d8c3a4afc https://medicaldevicecourses.com/activity/p/21442/ Fri, 26 Feb 2021 21:02:52 -0500 0