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	<title>Medical Device Courses | bms56 | Activity</title>
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				<title>bms56 replied to the topic  &#034;When Mitigation Becomes Its Own Risk!&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33710/</link>
				<pubDate>Sun, 16 Nov 2025 22:09:03 -0500</pubDate>

									<content:encoded><![CDATA[<p>Risk controls should be kept in their design when it effectively mitigates a risk. When a mitigation effort lowers the initial risk but introduces new issues that are even worse, such as more components that could malfunction, I believe that&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/risk-analysis-for-medical-devices/when-mitigation-becomes-its-own-risk/#post-22753" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Risk Management Team =/= Project Team&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33709/</link>
				<pubDate>Sun, 16 Nov 2025 21:55:42 -0500</pubDate>

									<content:encoded><![CDATA[<p>The project team and the risk management team shouldn&#8217;t necessarily be the same individuals because this might lead to heavy bias and/or blind spots. When you build a device, of course you would want it to function, which may cause&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/risk-analysis-for-medical-devices/risk-management-team-project-team/#post-22752" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Can Risk Really Be Eliminated — or Only Managed?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33708/</link>
				<pubDate>Sun, 16 Nov 2025 21:42:33 -0500</pubDate>

									<content:encoded><![CDATA[<p>Since there are no zero-risk medical devices, I believe the objective should always be to lower risk to a manageable level rather than strive for something that&#8217;s zero-risk. Nothing would ever reach patients if businesses attempted to eliminate every potential&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/risk-analysis-for-medical-devices/can-risk-really-be-eliminated-or-only-managed/#post-22751" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Capstone Project Proposals (Shortened PDF)&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33586/</link>
				<pubDate>Mon, 10 Nov 2025 01:45:02 -0500</pubDate>

									<content:encoded><![CDATA[<p>My team and I created a 3D-printed lattice cushioning system for construction helmets in order to lower the risk of traumatic brain injury for our capstone project. The idea was to replace conventional foam liners with a multi-layer lattice that&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/capstone-project-proposals-shortened-pdf/#post-22659" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Efficiency or Compliance?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33582/</link>
				<pubDate>Mon, 10 Nov 2025 01:22:36 -0500</pubDate>

									<content:encoded><![CDATA[<p>I believe that many businesses, particularly smaller ones that are under pressure to launch a product quickly, first view design controls as merely another regulatory box to check. It&#8217;s simple to think of them as more paperwork rather than anything&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/efficiency-or-compliance/#post-22655" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Process Validation for OEMs&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33578/</link>
				<pubDate>Sun, 09 Nov 2025 23:27:43 -0500</pubDate>

									<content:encoded><![CDATA[<p>I think a good contract manufacturer should do more than just produce the parts they should also thoroughly record every stage of the process, including operator training, equipment qualifications, and standard operating procedures. In order to show that the procedure&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/process-validation-for-oems/#post-22651" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Bridging the Gap Between Users Needs and Design Inputs&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33456/</link>
				<pubDate>Mon, 03 Nov 2025 02:45:49 -0500</pubDate>

									<content:encoded><![CDATA[<p>I think that defining &#8220;success&#8221; in quantifiable terms is the first step to converting a qualitative user need into a quantitative design input. If a user requests that a device should be easy to clean you could decide that all&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/bridging-the-gap-between-users-needs-and-design-inputs/#post-22570" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Consequences Of Insufficient Design Controls&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33455/</link>
				<pubDate>Mon, 03 Nov 2025 02:31:00 -0500</pubDate>

									<content:encoded><![CDATA[<p>Improper implementation of design control might lead to several issues later on. Problems with the device may not become apparent until the end of development or even after it has been put on the market. It&#8217;s quite difficult to determine&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/consequences-of-insufficient-design-controls/paged/9/#post-22569" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Design Verification Ethics&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33454/</link>
				<pubDate>Mon, 03 Nov 2025 02:22:34 -0500</pubDate>

									<content:encoded><![CDATA[<p>Although I haven&#8217;t personally witnessed businesses doing this, as I believe a majority of people haven&#8217;t, I am aware that certain employees may be tempted to cut corners in order to save time by ignoring unsuccessful verification processes. Doing something&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/design-verification-ethics/paged/2/#post-22568" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Placebo Effect&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33342/</link>
				<pubDate>Mon, 27 Oct 2025 03:02:08 -0400</pubDate>

									<content:encoded><![CDATA[<p>The placebo effect can definitely cause some difficulties in clinical studies. It really is amazing how, even if the medication isn&#8217;t helping in itself, the mere belief that you&#8217;re receiving treatment may improve your health, at least mentally. It can&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/clinical-research-basics/placebo-effect/paged/2/#post-22479" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Clinical Trial Roles&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33341/</link>
				<pubDate>Mon, 27 Oct 2025 02:47:38 -0400</pubDate>

									<content:encoded><![CDATA[<p>I think I would like to work on the data management team if I was a part of a clinical research trial. The analytical aspect of research has always piqued my interest when it comes to verifying the accuracy of&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/clinical-research-basics/clinical-trial-roles/paged/5/#post-22478" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Double Blind Vs Single blind Study&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33340/</link>
				<pubDate>Mon, 27 Oct 2025 02:33:57 -0400</pubDate>

									<content:encoded><![CDATA[<p>I see your point that double blind trials appear to be a waste of time, but i think they have a decent purpose as others have said. It helps ensure that no one&#8217;s expectations unintentionally affect the results when neither&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/clinical-research-basics/double-blind-vs-single-blind-study/paged/8/#post-22477" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Brand Coloring&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33225/</link>
				<pubDate>Sun, 19 Oct 2025 19:16:00 -0400</pubDate>

									<content:encoded><![CDATA[<p>I&#8217;ve seen that many businesses spend a lot of time and money for their color selections, especially in relation to the feelings they hope to manifest. For instance, white, silver, and blue hues are frequently used by tech companies such&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/marketing-and-sales/brand-coloring/paged/6/#post-22380" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Transition from Engineering to sales or marketing?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33224/</link>
				<pubDate>Sun, 19 Oct 2025 19:04:10 -0400</pubDate>

									<content:encoded><![CDATA[<p>Personally, I would prefer to continue working as an engineer. I like the technical problem solving aspect of engineering at least more than I would trying to sell something to someone, even if marketing and sales may be thrilling once&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/marketing-and-sales/transition-from-engineering-to-sales-or-marketing/paged/2/#post-22379" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Discussion Topic: The Fifth &#034;P&#034; of Marketing&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33223/</link>
				<pubDate>Sun, 19 Oct 2025 18:53:40 -0400</pubDate>

									<content:encoded><![CDATA[<p>I have noticed the use of Spotify&#8217;s &#8220;Wrapped&#8221; feature as one instance of clever marketing participation. For those unaware the concept is pretty straightforward. Users show the songs and artists they have listened to the most resulting in millions of&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/marketing-and-sales/discussion-topic-the-fifth-p-of-marketing/paged/7/#post-22378" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Business Courses for Engineering Students?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/33025/</link>
				<pubDate>Sun, 12 Oct 2025 20:32:24 -0400</pubDate>

									<content:encoded><![CDATA[<p>I believe it would be very useful to add an additional business subject to take. The majority of us graduate with knowledge of how to design or construct things, but not necessarily how a business operates or generates revenue. Having&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/business-101/business-courses-for-engineering-students/paged/2/#post-22280" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;MBA/ Business degree for Engineers&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/32989/</link>
				<pubDate>Sat, 11 Oct 2025 22:06:19 -0400</pubDate>

									<content:encoded><![CDATA[<p>I believe an MBA is not required for an engineer to launch a profitable company. Experience and problem-solving are the main factors that determine success in my opinion, even though business education can provide useful management and financial abilities. The&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/business-101/mba-business-degree-for-engineers/paged/2/#post-22268" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Accepting job based on company.&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/32988/</link>
				<pubDate>Sat, 11 Oct 2025 21:41:38 -0400</pubDate>

									<content:encoded><![CDATA[<p>Depending on the organization, I would definitely decline a job offer if I had the option to choose. The research I would do on the company would not be extensive, but there would be some. Compared to a sole proprietorship&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/business-101/accepting-job-based-on-company/paged/8/#post-22267" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Punishment for Failing FDA Audits&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/32513/</link>
				<pubDate>Mon, 29 Sep 2025 03:26:41 -0400</pubDate>

									<content:encoded><![CDATA[<p>From what I understand, the FDA usually distinguishes between major and minor nonconformances. A couple of small errors in labeling or paperwork that don&#8217;t directly impact the safety or effectiveness of the device would likely be documented as observations in&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/regulatory-basics-for-medical-devices/punishment-for-failing-fda-audits/#post-22103" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Discussion Topic: Make a few, sell a few&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/32511/</link>
				<pubDate>Mon, 29 Sep 2025 03:13:36 -0400</pubDate>

									<content:encoded><![CDATA[<p>I think a physician who wants to create their own medical device would face a lot of challenges, even though their medical expertise would give them a strong starting point. One major obstacle is the gap between knowing what patients&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/regulatory-basics-for-medical-devices/discussion-topic-make-a-few-sell-a-few/paged/4/#post-22101" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Does the FDA guarantee safety?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/32509/</link>
				<pubDate>Mon, 29 Sep 2025 03:01:21 -0400</pubDate>

									<content:encoded><![CDATA[<p>Sometimes I get surprised by how the FDA works as approval doesn&#8217;t mean a drug is completely safe, it just means the benefits outweigh the risks for most people. Accutane is a good example to bring up, as it works&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/regulatory-basics-for-medical-devices/does-the-fda-guarantee-safety/paged/3/#post-22100" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Why Is Pre-clinical Research So Important Before Testing on Humans?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/32250/</link>
				<pubDate>Mon, 22 Sep 2025 03:52:34 -0400</pubDate>

									<content:encoded><![CDATA[<p>I agree that pre-clinical research is a critical safety checkpoint in medical device development as I am sure most would. Using human subjects to immediately test something new without immense knowledge on the consequences of those actions is what we&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/pre-clinical-device-development/why-is-pre-clinical-research-so-important-before-testing-on-humans/#post-22011" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Ethics of Animal Testing&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/32248/</link>
				<pubDate>Mon, 22 Sep 2025 03:38:53 -0400</pubDate>

									<content:encoded><![CDATA[<p>Pre-clinical studies are critical for developing safe and effective medications, devices, etc, but ethics no matter the topic can ever be ignored. Animal research has played an immense role in medical breakthroughs that save human lives. Vaccines, surgical techniques, anatomical&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/pre-clinical-device-development/ethics-of-animal-testing/paged/9/#post-22009" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Research for the Fututre or Now?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/32244/</link>
				<pubDate>Mon, 22 Sep 2025 03:25:33 -0400</pubDate>

									<content:encoded><![CDATA[<p>If i were to pick only one option I would pick the results of my research to be applied right away to help the people of my generation, but that&#8217;s not to say that others should follow my footsteps as&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/pre-clinical-device-development/research-for-the-fututre-or-now/paged/10/#post-22005" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Teamwork in Projects&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/31956/</link>
				<pubDate>Mon, 15 Sep 2025 03:17:34 -0400</pubDate>

									<content:encoded><![CDATA[<p>To answer the question on what the biggest challenge in teamwork is I would choose people not doing their share of the work. Members of a team disagreeing on ideas is bound to happen and personally I don&#8217;t discourage it&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/intro-to-project-management/teamwork-in-projects/#post-21909" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Milestones Missed: Failure or Success?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/31953/</link>
				<pubDate>Mon, 15 Sep 2025 02:49:04 -0400</pubDate>

									<content:encoded><![CDATA[<p>I believe that missing a milestone in a project doesn&#8217;t automatically mean failure, but it depends on the type of milestone missed as it can actually be a step forward towards success. Milestones are tools to help measure progress and&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/intro-to-project-management/milestones-missed-failure-or-success/paged/6/#post-21906" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bms56 replied to the topic  &#034;Which feature is the most important for a project manager?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/31950/</link>
				<pubDate>Mon, 15 Sep 2025 02:27:29 -0400</pubDate>

									<content:encoded><![CDATA[<p>I think that the most important feature for a project manager is definitely effective communication. A manager acts as the central point of contact between the team and clients, so being able to clearly and concisely convey goals and responsibilities&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/intro-to-project-management/which-feature-is-the-most-important-for-a-project-manager/paged/3/#post-21903" rel="nofollow ugc">Read more&raquo;</a></p>
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