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	<title>Medical Device Courses | yroberts | Activity</title>
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				<title>yroberts replied to the topic  &#034;Design Control Experience&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23745/</link>
				<pubDate>Sat, 16 Oct 2021 17:50:54 -0400</pubDate>

									<content:encoded><![CDATA[<p>I&#8217;ve had experience with design control during my undergrad capstone. I got my B.S. in mechatronics engineering and the capstone had to be electronic with other guidelines. We didn&#8217;t do the specified documentation presented in this lecture but our report&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/design-control-experience/#post-13102" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;Validation Types&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23744/</link>
				<pubDate>Sat, 16 Oct 2021 17:33:37 -0400</pubDate>

									<content:encoded><![CDATA[<p>I&#8217;ve been through a process validation before as an Engineering intern. Process validation is the gathering and assessment of data from the process design stage through production to produce scientific proof that a process is capable of consistently providing high-quality&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/validation-types/#post-13101" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;Design Controls: What do you deem most important?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23737/</link>
				<pubDate>Sat, 16 Oct 2021 06:54:51 -0400</pubDate>

									<content:encoded><![CDATA[<p>I think the required documentation for design control is most important. Revised design control documentation serves as a valuable source of truth for the project.  Recording everything in one document helps you to organize your thoughts, makes it easier to&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/design-controls-what-do-you-deem-most-important/#post-13093" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;What is risk control? What are some examples of risk control measures taken?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23736/</link>
				<pubDate>Sat, 16 Oct 2021 06:37:40 -0400</pubDate>

									<content:encoded><![CDATA[<p>Risk control should form part of the company`s broader health and safety plan providing a method to identify, control, and reduce the risks present in the workplace. The control of workplace risk is a practical, evidence-driven process; employers assess the&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/risk-analysis-for-medical-devices/what-is-risk-control-what-are-some-examples-of-risk-control-measures-taken/#post-13092" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;What is Risk-benefit analysis ?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23735/</link>
				<pubDate>Sat, 16 Oct 2021 06:23:20 -0400</pubDate>

									<content:encoded><![CDATA[<p>One factor is the likelihood that the patient will receive one or more benefits — using the information supplied, it is occasionally feasible to forecast which patients would benefit. It&#8217;s also feasible that various patient subgroups will get different results,&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/risk-analysis-for-medical-devices/what-is-risk-benefit-analysis/paged/3/#post-13091" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;Two Types of Risk&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23734/</link>
				<pubDate>Sat, 16 Oct 2021 03:06:37 -0400</pubDate>

									<content:encoded><![CDATA[<p>Internal risk includes personnel management concerns such as labor shortages or low morale, as well as technology difficulties such as outdated software. External risks include economic slowdowns, which result in lower revenue, as well as political dangers from trade wars,&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/risk-analysis-for-medical-devices/two-types-of-risk/#post-13090" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;Organization types of medical devices?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23733/</link>
				<pubDate>Fri, 15 Oct 2021 19:49:36 -0400</pubDate>

									<content:encoded><![CDATA[<p>If I were to create a medical device firm, I believe I would do so as a project-based company at first. PBOs are more concerned with project outcomes than with organizational structure. In compared to other organizations, I feel this&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/organizational-development-in-device-companies/organization-types-of-medical-devices/paged/3/#post-13089" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;project management: organization structure&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23732/</link>
				<pubDate>Fri, 15 Oct 2021 19:15:27 -0400</pubDate>

									<content:encoded><![CDATA[<p>  In a functional organization, projects that exist within a single functional division generate no organizational issues. But projects that extend across functional divisions are demanding to manage. This is because the project manager has no direct functional authority and&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/organizational-development-in-device-companies/project-management-organization-structure/#post-13088" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;Contract Laws&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23731/</link>
				<pubDate>Fri, 15 Oct 2021 18:01:26 -0400</pubDate>

									<content:encoded><![CDATA[<p>I work for Coca-Cola which is now operating in more than 200 countries and producing nearly 500 brands. From a legal and management standpoint, the Coca-Cola company is not a single organization, and the Company does not own or control&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/consultants-and-legal-basics/contract-laws/#post-13087" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts posted a new topic  &#034;Clinical Trial Phase 2 Observations&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23476/</link>
				<pubDate>Sat, 25 Sep 2021 23:53:48 -0400</pubDate>

									<content:encoded><![CDATA[<p>The researchers will choose a few patients to test the impact of the new medications. Researchers learn about the effects of new medications by studying the reactions of these few people in four phases. In phase 2, the individuals are&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/clinical-research-basics/clinical-trial-phase-2-observations/" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts posted a new topic  &#034;Double Blind Experiment for Fibroids&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23475/</link>
				<pubDate>Sat, 25 Sep 2021 23:46:28 -0400</pubDate>

									<content:encoded><![CDATA[<p>The double-blind experiment is a technique used to increase internal validity. Therefore, we do not provide any information about the experiments to the participants or the experimenter. You are participating in the design of a medical experiment to investigate whether&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/clinical-research-basics/double-blind-experiment-for-fibroids/" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts posted a new topic  &#034;Good Clinical Practices within Job Roles&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23472/</link>
				<pubDate>Sat, 25 Sep 2021 23:18:28 -0400</pubDate>

									<content:encoded><![CDATA[<p>On any job search engine, search GCP. Select and define a role here. What are some of the benefits of GCP involved with the job role you selected? Does the job also include clinical research in the description?</p>
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				<title>yroberts posted a new topic  &#034;Who Are You Selling To?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23381/</link>
				<pubDate>Sun, 19 Sep 2021 01:14:21 -0400</pubDate>

									<content:encoded><![CDATA[<p>You are currently developing a company to manufacturer dental tools. Who are you planning to sale to? (Physician, Hospital, Retailer) Explain your answer.</p>
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				<title>yroberts posted a new topic  &#034;SWOT Analysis for Medical Device Start-Up&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23380/</link>
				<pubDate>Sun, 19 Sep 2021 01:06:24 -0400</pubDate>

									<content:encoded><![CDATA[<p> <br />
Your client is a medical device start-up developing a internal stent. In order to market this device in the US, the client needs your help with a “SWOT” analysis. Develop a short, basic analysis briefing all elements.</p>
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				<title>yroberts posted a new topic  &#034;Comparing Medical Device Businesses&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23379/</link>
				<pubDate>Sun, 19 Sep 2021 00:53:10 -0400</pubDate>

									<content:encoded><![CDATA[<p><strong>Research two businesses currently supplying medical devices on the market. Describe how they defer from each other including type of corporation, size, and finances. Also describe a similarity like type of product or marketing strategy.</strong></p>
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				<title>yroberts posted a new topic  &#034;Careers in Quality Management&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23272/</link>
				<pubDate>Sun, 12 Sep 2021 00:19:40 -0400</pubDate>

									<content:encoded><![CDATA[<p>QA/QC are apart of the quality management system. Low to high level positions are available for one to pursue in ensuring and controlling quality. Name a role one could take. Mention the responsibilities, qualifications, and typical work environment. Can you&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/quality-control-and-quality-assurance/careers-in-quality-management/" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;The people we shall encounter in the field&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23269/</link>
				<pubDate>Sun, 12 Sep 2021 00:11:55 -0400</pubDate>

									<content:encoded><![CDATA[<p>Only certain human differences impact my outlook on another people in the workplace. It’s not looks nor demographic backgrounds. However, what the person possesses in character, life experience and knowledge make me view and work with others differently. In the&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/regulatory-basics-for-medical-devices/the-people-we-shall-encounter-in-the-field/paged/2/#post-12644" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts posted a new topic  &#034;QA/QC for a Medical Device Project&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23267/</link>
				<pubDate>Sat, 11 Sep 2021 23:53:21 -0400</pubDate>

									<content:encoded><![CDATA[<p>Quality Control is product oriented involving low/mid-level employees, while Quality Assurance is process oriented with high-level employees implementing responsibilities. QC is inspections of the quality of a product and classifies it under the domain of QC. QC does not guarantee&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/quality-control-and-quality-assurance/qa-qc-for-a-medical-device-project/" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts posted a new topic  &#034;Ethical Guidelines for Animal Use in Research&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23169/</link>
				<pubDate>Sun, 05 Sep 2021 04:27:58 -0400</pubDate>

									<content:encoded><![CDATA[<p>The National Committee for Research Ethics in Science and Technology (NENT) has made guidelines to support ethical principles for researchers who are considering experimentations on animals. The guidelines primarily address the “researcher” but nonetheless, it applies to any individual involved&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/pre-clinical-device-development/ethical-guidelines-for-animal-use-in-research/" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts posted a new topic  &#034;Academia Grant Proposal for Medical Device Development&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23160/</link>
				<pubDate>Sun, 05 Sep 2021 02:15:54 -0400</pubDate>

									<content:encoded><![CDATA[<p>You are on a research commission that oversees all the written proposals and budgets from students for grants. The commission is presented with a proposal for funding of the development of implantation device from the biomedical engineering program’s capstone project&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/pre-clinical-device-development/academia-grant-proposal-for-medical-device-development/" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts posted a new topic  &#034;Animal Diversity in Pre-clinical Research&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23159/</link>
				<pubDate>Sun, 05 Sep 2021 01:47:04 -0400</pubDate>

									<content:encoded><![CDATA[<p>Preclinical research trials were performed on a single lab creature such as rodent, rabbit, or monkey of same kind in each lab. Most recent investigate appears that having an animal model and conditional differences in the studies can progress the&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/pre-clinical-device-development/animal-diversity-in-pre-clinical-research/" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts posted a new topic  &#034;Medical Device R&#038;D&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23107/</link>
				<pubDate>Tue, 31 Aug 2021 20:13:10 -0400</pubDate>

									<content:encoded><![CDATA[<p>As a biomedical engineer, you are asked to design medical devices to be used in hospital.Create a business case for the initiation phase of PM for the medical device. Suggest what the feasibility study should be on.   </p>
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				<title>yroberts posted a new topic  &#034;Application of Biomedical Engineering&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23106/</link>
				<pubDate>Tue, 31 Aug 2021 19:54:16 -0400</pubDate>

									<content:encoded><![CDATA[<p>The field of biomedical engineering has experienced significant growth in recent years. Biomedical engineering applies engineering principles to help solve problems in the medical field for human health. What is the most important issue Biomedical Engineering is facing and what&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-medical-device-development/application-of-biomedical-engineering/" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;Discussion Topic: Biomedical Engineering vs. Bioengineering&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23105/</link>
				<pubDate>Tue, 31 Aug 2021 19:44:08 -0400</pubDate>

									<content:encoded><![CDATA[<p>Bioengineering and biomedical engineering are two important advancements if the field of science and technology. Bioengineering focuses on the application of engineering on biological processes, food, agriculture and environmental processes. While biomedical engineering has more complex subdivisions, which focuses on&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-medical-device-development/biomedical-engineering-vs-bioengineering/#post-12506" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts posted a new topic  &#034;Areas of Management: Resources vs Procurement&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23000/</link>
				<pubDate>Sun, 22 Aug 2021 00:07:41 -0400</pubDate>

									<content:encoded><![CDATA[<p>Compare and contrast resource management and procurement management. Include the processes, importance, and the individual subjects involved.<br />
Do you feel like either area is more important than the other?</p>
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				<title>yroberts replied to the topic  &#034;Sucess Factors&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/22999/</link>
				<pubDate>Fri, 20 Aug 2021 19:51:36 -0400</pubDate>

									<content:encoded><![CDATA[<p>I agree that the list of successful factors are some of the most important attributes to project development. First and foremost, the willingness has to be present. Every team member will be expected to take responsibility for their role. This&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/project-management-process-and-medical-device-development/sucess-factors/paged/4/#post-12464" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;Discussion Topic: The proper time for Project Initiation&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/22981/</link>
				<pubDate>Wed, 11 Aug 2021 22:15:41 -0400</pubDate>

									<content:encoded><![CDATA[<p>Beginning a project is invigorating, yet you should do your due to initiate early to guarantee you get going on the right foot. It’s critical for how to make a venture contract, characterize scope, distinguish goals &amp; designs, and set&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/project-management-process-and-medical-device-development/discussion-topic-the-proper-time-for-project-initiation/paged/2/#post-12436" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;Design Review Meetings&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/22978/</link>
				<pubDate>Tue, 10 Aug 2021 00:58:29 -0400</pubDate>

									<content:encoded><![CDATA[<p>During my senior capstone project, this type of situation happened frequently due to the pandemic. My semester was the first to endure the COVID-19 pandemic and had campus access taken away. So during most of the design meetings, we had&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/project-management-process-and-medical-device-development/design-review-meetings-2/#post-12433" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;Projects and Programs&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/22925/</link>
				<pubDate>Mon, 19 Jul 2021 03:27:00 -0400</pubDate>

									<content:encoded><![CDATA[<p>Posted by: <a href='https://medicaldevicecourses.com/members/zcornelius21/' rel="nofollow ugc">@zcornelius21</a> What are the advantages of grouping projects under a program? There are several advantage to this arrangement. One benefit is easier management. When you think about the program you can view it as an algorithm and the&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-project-management/projects-and-programs/#post-12342" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts replied to the topic  &#034;Class II Medical Devices&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/22904/</link>
				<pubDate>Sun, 11 Jul 2021 02:32:44 -0400</pubDate>

									<content:encoded><![CDATA[<p>  Most medical devices are viewed as Class II devices. Class II devices are those 43% of clinical gadgets that have a moderate risk which general controls are not adequate to guarantee wellbeing and viability to the patient. The FDA&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-project-management/class-ii-medical-devices/#post-12312" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>yroberts became a registered member</title>
				<link>https://medicaldevicecourses.com/activity/p/22889/</link>
				<pubDate>Wed, 07 Jul 2021 21:17:18 -0400</pubDate>

				
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