https://medicaldevicecourses.com/members/agebraeil/activity/ Activity feed for agebraeil. Sat, 16 May 2026 10:34:20 -0400 https://buddypress.org/?v= en-US 30 hourly 2 8c23ff04eaa491f24e22627bb9e2bf0f https://medicaldevicecourses.com/activity/p/33699/ Sun, 16 Nov 2025 19:35:55 -0500 I agree that avoidance is often the way that is preferred in manufacturing because preventing a risk before it happens is the most reliable way to protect both workers and product quality. When avoidance isn’t possible, mitigation is crucial through…   Read more»

]]> 2bbac1c3b609192e61ca3d8d6648e62a https://medicaldevicecourses.com/activity/p/33698/ Sun, 16 Nov 2025 19:26:51 -0500 To put a plan into action, I would focus on using tools and methods that help me stay organized about potential problems. I would start with a detailed risk register so I can track each risk, who its owned by,…   Read more»

]]> 8d943f9f24e432bc0baedbc45df6dc3d https://medicaldevicecourses.com/activity/p/33697/ Sun, 16 Nov 2025 19:23:07 -0500 This post brings up an important point about whether the use of FMEA has become too rigid for the reality of modern devices. FMEA is a useful starting tool but it usually fails to capture the unpredictable ways failure can…   Read more»

]]> d7b902cc0068bb6813cd92bbd3cd0919 https://medicaldevicecourses.com/activity/p/33564/ Sun, 09 Nov 2025 19:29:30 -0500 Rebuilding a design history file for a legacy combination product can be hard especially when the original documentation isn’t finished or does not exist. Since a lot of these products were made before modern design controls, the best method is…   Read more»

]]> 542ed5ad7365e1bca57fe9898c0e8f0d https://medicaldevicecourses.com/activity/p/33563/ Sun, 09 Nov 2025 19:23:54 -0500 A contract manufacturer plays a important role in process validation by giving documented evidence that the manufacturing equipment, processes, and controls are capable of consistently producing products that meet specifications. A contract manufacturer is expected to give detailed process documentation,…   Read more»

]]> 507d003def0488c7889d1b03ac42de6b https://medicaldevicecourses.com/activity/p/33562/ Sun, 09 Nov 2025 19:01:33 -0500 Even though verification and validation may seem similar, they do serve different purposes. Verification is focused on confirming that the design meets the technical and regulatory requirements. Validation makes sure that the product meets the user’s needs and performs efficiently…   Read more»

]]> 096f06a678db01e89211555e6689b900 https://medicaldevicecourses.com/activity/p/33419/ Sun, 02 Nov 2025 01:28:12 -0400 The best way to translate a qualitative user need into a testable and quantitive design input is by breaking it down into measurable criteria. To maintain traceability, teams can utilize a design traceability matrix thank connects each user need to…   Read more»

]]> dae74cd64d047bbb57996da18495edeb https://medicaldevicecourses.com/activity/p/33417/ Sun, 02 Nov 2025 00:38:50 -0400 I think that multiple design reviews should be held throughout the development process. Each stage of design can reveal different issues that might not be able to seen later. Having several reviews helps ensure that the risks are identified early…   Read more»

]]> bac2ddd1f93b0583c22431f48183139a https://medicaldevicecourses.com/activity/p/33416/ Sun, 02 Nov 2025 00:05:42 -0400 I think design controls can actually support innovation when they are utilized in the correct way. Although ISO 13485 and FDA 21 CFR 820 seem rigid, they help teams think through safety, user needs, and risks before going too far…   Read more»

]]> 0127102de92333dec31c1b6954ac0446 https://medicaldevicecourses.com/activity/p/33282/ Fri, 24 Oct 2025 14:37:28 -0400 Clinical studies are crucial in advancing medicine because they give the evidence necessary to determine whether new drugs and medical devices are effective and safe. One advantage is that they lead to discoveries that can saves lives which helps patients…   Read more»

]]> 48a51caeb0feba0c64a7a493d42e4ca6 https://medicaldevicecourses.com/activity/p/33281/ Fri, 24 Oct 2025 14:22:53 -0400 The placebo effect can complicate clinical trials because it makes it harder to tell whether improvements in patients are because of the actual drug or the belief in the treatment. The psychological response can hide the effectiveness of a medication,…   Read more»

]]> eba749dbc6b7d90534b5db4fda75e115 https://medicaldevicecourses.com/activity/p/33280/ Fri, 24 Oct 2025 14:15:09 -0400 I think participants in pharmaceutical trials should receive compensation in some situations if it is ethical. The compensation should be based on the type of risk and time that the trial is. I think there should be a screening process…   Read more»

]]> bb7ea72b95442f2f34bc82126f8532fc https://medicaldevicecourses.com/activity/p/33228/ Sun, 19 Oct 2025 20:31:58 -0400 Participation in marketing is when brands invite customers to help shape their products. Crumbl cookies for example use changing their cookies once a week as marketing to their customers. When customers feel like their voices matter they are more likely…   Read more»

]]> b6a4600e923466ae9b90d59acccfc843 https://medicaldevicecourses.com/activity/p/33227/ Sun, 19 Oct 2025 20:24:56 -0400 Personally, as a biomedical engineer, I would choose marketing after an engineering role. I think I would be able to use my background to understand customer needs and product design. Engineers are trained to solve problems which is why I…   Read more»

]]> 4b7b9066c629f5342ff95f3e035d8253 https://medicaldevicecourses.com/activity/p/33226/ Sun, 19 Oct 2025 20:13:17 -0400 I do agree that color is one of the most crucial tools that is used in branding because they appeal to consumers. For example coca-cola uses red because its bold. Every color displays a different mood and companies/brands do rely…   Read more»

]]> 0566fc15c215ad5e8d7f1be32008422c https://medicaldevicecourses.com/activity/p/32993/ Sun, 12 Oct 2025 00:29:18 -0400 I think these business courses are very beneficial for engineers that want to work in the industry. I took classes like these and they helped me learn a lot and I think they are very important. While technical knowledge is…   Read more»

]]> f4107b0615e83458512eb0e0c8160973 https://medicaldevicecourses.com/activity/p/32992/ Sun, 12 Oct 2025 00:24:55 -0400 I think the type of company can play a role in deciding whether to accept a job, but it wouldn’t be the only factor. Some companies will offer more stability and opportunities because they can be larger, while smaller companies…   Read more»

]]> 9085b970ff6b585ac185060cecee49d9 https://medicaldevicecourses.com/activity/p/32991/ Sun, 12 Oct 2025 00:18:22 -0400 This is an interesting topic and it is important to discuss. I do think further education can be beneficial but I do not think it is necessary in all situations. Further education is important when the thing you are doing…   Read more»

]]> ba086f245809d6cc8cbeebf4d16473c2 https://medicaldevicecourses.com/activity/p/32685/ Fri, 03 Oct 2025 19:18:08 -0400 I think technology is always evolving and it is doing so rapidly so I do believe that QA should adapt to the rapidly changing technology. Tools like AI can be beneficial in making processes go faster and improve outcomes. I…   Read more»

]]> 39250e452e41501394dc4b885adb76b0 https://medicaldevicecourses.com/activity/p/32684/ Fri, 03 Oct 2025 19:07:56 -0400 I think that both quality assurance and quality control are crucial for patient safety. QA is important because it focuses on preventing issues before they happen. Through training, QA establishes clear processes and minimizes the chances of problems making it…   Read more»

]]> a9dd0e195f0bc54116c1c4c999db9656 https://medicaldevicecourses.com/activity/p/32683/ Fri, 03 Oct 2025 19:01:32 -0400 I think the most efficient way for quality teams to collaborate with R&D teams would be for both teams to communicate with each other consistently. I think quality teams should be involved in the early development process so they can…   Read more»

]]> c411b887bcf927519b44a9f74671af00 https://medicaldevicecourses.com/activity/p/32470/ Sun, 28 Sep 2025 17:32:34 -0400 This is a good question that is difficult to answer. I do not think that FDA approval means a drug or device is risk free. There have been many drugs that have been approved and put out on market but…   Read more»

]]> 42b171d69c7077037f1a101505c4efdb https://medicaldevicecourses.com/activity/p/32466/ Sun, 28 Sep 2025 17:14:13 -0400 A product that was recently recalled is Zantac. This is a heartburn drug and it was recalled in 2019 because of a cancer causing chemical called NDMA. This became clear after testing when it was in market. I do not…   Read more»

]]> 14b7973a429a745ba19a767a2114bdde https://medicaldevicecourses.com/activity/p/32465/ Sun, 28 Sep 2025 16:56:39 -0400 I think the best thing to do depends on the project and whether or not it’s a small startup or a larger company. For small startups, I think it makes sense to focus on the innovation first which allows engineers…   Read more»

]]> d60eaf6e93161629e6e43144e910cf7a https://medicaldevicecourses.com/activity/p/32205/ Sun, 21 Sep 2025 20:47:21 -0400 I agree, preclinical research is crucial in making sure the safety before going through human trials. This is especially true for medical devices that could be a serious threat if something goes wrong. I do believe that animal testing has…   Read more»

]]> 7fb911612eca84517673f219382aaac7 https://medicaldevicecourses.com/activity/p/32204/ Sun, 21 Sep 2025 20:39:02 -0400 I agree that choosing the correct animal model is crucial in research especially in neuroscience. Due to the brain being complex, using models that are close to human biology can improve the accuracy of the findings. Rodents are usually used…   Read more»

]]> 84c489a81fd78c06c29cbd5b3cf72c25 https://medicaldevicecourses.com/activity/p/32203/ Sun, 21 Sep 2025 20:33:46 -0400 I think that both short and long term research have value. I believe that research that helps people right away is more beneficial. It allows the researchers to see how their work has improved people’s lives. I think long term…   Read more»

]]> f4fec2f2da224f504b3cc90ed2c08e78 https://medicaldevicecourses.com/activity/p/31855/ Fri, 12 Sep 2025 16:25:56 -0400 Missing a milestone is a failure, if you have a deadline you should be able to meet it if you are managing your time correctly. Being diligent of a milestone is important especially in the industry because if a deadline…   Read more»

]]> 1e4295f4fb6ef63ba26637b0da89aa9c https://medicaldevicecourses.com/activity/p/31854/ Fri, 12 Sep 2025 16:08:11 -0400 It is crucial that the project manager deals with budget concerns by evaluating where all the costs can be allocated. When exceeding the budget, it is important that the project manager evaluates where the money is being allocated. Every single…   Read more»

]]> 90d63ad336bc4ac7d82d320f03247389 https://medicaldevicecourses.com/activity/p/31853/ Fri, 12 Sep 2025 15:47:44 -0400 I think that having a timeline when it comes to project management is crucial in ensuring an effective project. I believe that you need to prioritize all tasks efficiently and in a smart way. A timeline is important because it…   Read more»

]]> 802f27e9616bdefda54a4091d1b710f5 https://medicaldevicecourses.com/activity/p/31826/ Wed, 10 Sep 2025 00:40:00 -0400 I do think that medical device certification is an important step in the process of development even if it is not a main focus. I do believe that it is a useful certification to have considering when working with these…   Read more»

]]> e7c1cc325da88aead1c7bae8e3b2a7e4 https://medicaldevicecourses.com/activity/p/31825/ Wed, 10 Sep 2025 00:27:41 -0400 I do not believe that AI is going to control the medical industry but I do think it is going to change it. I believe that AI has the potential to affect the industry efficiently but it is not able…   Read more»

]]> bef481f88eb5ee29216a3e6d7c64a749 https://medicaldevicecourses.com/activity/p/31824/ Wed, 10 Sep 2025 00:18:10 -0400 I think AI is one of the biggest improvements in the medical device industry. I believe that it can be used to improve accuracy and personalize treatments more efficiently. I have read that AI can identify things that are wrong…   Read more»

]]> 9a079b0b5ff2b9cf5c8d558167130dec https://medicaldevicecourses.com/activity/p/31817/ Tue, 09 Sep 2025 17:51:26 -0400 @vanshamin I completely agree that AI has completely changed the industry and how things work. I do believe that AI has made it possible to manufacture medical devices but I do agree that the FDA has made the process slower….   Read more»

]]> 12dc6d9f21672a22610826931b836bac https://medicaldevicecourses.com/activity/p/31723/ Fri, 05 Sep 2025 00:51:19 -0400 0