https://medicaldevicecourses.com/members/mirna-cheikhali/activity/ Activity feed for Mirna Cheikhali. Sat, 25 Apr 2026 03:48:56 -0400 https://buddypress.org/?v= en-US 30 hourly 2 6132fac0d281dfa81d689c2e1d235ef5 https://medicaldevicecourses.com/activity/p/31537/ Sun, 04 May 2025 17:45:04 -0400 Great question! Project management tools definitely make a huge difference in planning and managing projects. Programs like Microsoft Project, Asana, or even tools like Jira can help with everything from scheduling to tracking progress. Some of these tools can automatically…   Read more»

]]> ad0e82f27de7365ea0df2cccea0065b9 https://medicaldevicecourses.com/activity/p/31536/ Sun, 04 May 2025 17:39:19 -0400 You’re right, scope creep is common in biomedical projects. To manage it, it’s crucial to set a clear project scope upfront and have a process for evaluating changes. Regular check ins and clear change management help keep things focused. Take…   Read more»

]]> 131e4f5d62dc5fcde01b2c094b293d05 https://medicaldevicecourses.com/activity/p/31535/ Sun, 04 May 2025 17:25:30 -0400 You make a really good point. In projects where the stakes are high, it’s so important to show that spending a bit more upfront on contingency planning isn’t a waste; it’s smart risk management. A good way to get that…   Read more»

]]> 67458d391925573484e390cf6eb7ee5d https://medicaldevicecourses.com/activity/p/31534/ Sun, 04 May 2025 17:14:42 -0400 That’s a tough situation but a pretty realistic one. At first, the excitement of working on something you’re passionate about can really drive you, but when you realize there’s no long term growth, it definitely becomes harder to stay motivated….   Read more»

]]> 9db07f1cffdf3209709481940d3c3d3c https://medicaldevicecourses.com/activity/p/31533/ Sun, 04 May 2025 17:11:23 -0400 Bartleby’s story really shows how motivation can disappear when someone feels disconnected at work. At first, he seemed like a great employee, quiet, reliable, and super productive. But then out of nowhere, he just started saying “I prefer not to”…   Read more»

]]> f4da180aa2b9570d5f852c813252e32e https://medicaldevicecourses.com/activity/p/31275/ Mon, 14 Apr 2025 03:54:01 -0400 Design review meetings play a big role in keeping projects on track, especially in the medical device space where documentation and compliance are so important. Even though I haven’t been directly involved in one yet, I’ve learned that solid preparation…   Read more»

]]> abd082c7419524da09a12f7a214adc16 https://medicaldevicecourses.com/activity/p/31274/ Mon, 14 Apr 2025 03:50:53 -0400 You make a great point about how important those early estimates are when it comes to using SV and CV effectively. I haven’t used these metrics myself yet, but it makes sense that if the original plan is off, like…   Read more»

]]> ca678b7a693056ba8b9311e7279357cc https://medicaldevicecourses.com/activity/p/31271/ Mon, 14 Apr 2025 03:48:55 -0400 I haven’t had any hands-on experience with EVM yet, but from what I’ve learned, it’s a valuable project management approach. One of EVM’s biggest strengths is how it combines scope, cost, and schedule into one system, making it easier to…   Read more»

]]> 100e0781f926dac4ec04b1d7b69fafb2 https://medicaldevicecourses.com/activity/p/30913/ Sun, 02 Mar 2025 21:57:30 -0500 I don’t have industry experience yet, but from what I’ve learned, figuring out the critical path seems super important for keeping projects on track. It makes sense that not all tasks are equally urgent, and if teams don’t recognize that,…   Read more»

]]> 8d596116b10e9877b451cfce2bf6fe75 https://medicaldevicecourses.com/activity/p/30912/ Sun, 02 Mar 2025 21:54:11 -0500 Keeping all the project elements coordinated across the 10 knowledge areas comes down to strong Integration Management, which keeps everything running smoothly. A solid project plan helps align the scope, schedule, budget, quality, resources, and risks while keeping communication clear…   Read more»

]]> e799f7d29f74aa6d9da825dc51e39b3c https://medicaldevicecourses.com/activity/p/30911/ Sun, 02 Mar 2025 21:50:34 -0500 Scope management goes hand in hand with time and cost management since all three work together to keep a project on track. The project scope lays out what needs to be done, which directly affects the schedule and budget. A…   Read more»

]]> abff563a1cc4af796f56936a6958d536 https://medicaldevicecourses.com/activity/p/30840/ Mon, 24 Feb 2025 02:55:15 -0500 I think your ranking makes a lot of sense, especially with SOPs being the easiest to change and anything after the design control phase being more complicated. SOPs are mostly procedural, so updating them is usually pretty straightforward since they…   Read more»

]]> 47c4921cb4897c50cc8b0675a849d45a https://medicaldevicecourses.com/activity/p/30838/ Mon, 24 Feb 2025 02:52:07 -0500 The most common risk in a project really depends on the industry and scope, but schedule risk tends to show up the most. Delays can happen for all sorts of reasons—resource shortages, technical challenges, or scope creep—and when deadlines slip,…   Read more»

]]> 2bb5874ce25a9df7d6f325b8ecb1c9a4 https://medicaldevicecourses.com/activity/p/30837/ Mon, 24 Feb 2025 02:50:00 -0500 Scope management goes hand in hand with time and cost management to keep projects on track. A clear scope helps with scheduling by breaking work into manageable tasks using a Work Breakdown Structure (WBS), making it easier to stick to…   Read more»

]]> cc614c66ff393e99c8394ec875f1fb27 https://medicaldevicecourses.com/activity/p/30641/ Sun, 09 Feb 2025 20:40:25 -0500 I totally agree—regular design reviews are key to catching issues early and avoiding costly delays. One way to make them more effective without slowing things down is by using real-time collaboration tools and simulation software. Digital twins and predictive modeling,…   Read more»

]]> deae78cd78b61a5d908caa00701412fb https://medicaldevicecourses.com/activity/p/30640/ Sun, 09 Feb 2025 20:36:24 -0500 In this week’s simulation, we were given a failed design verification test and tasked with redesigning the test to find out why it failed and how to fix the test. In the scenario given, there was a single factor that…   Read more»

]]> 8e5ca893e00dee4864c12b879eae1714 https://medicaldevicecourses.com/activity/p/30555/ Sun, 02 Feb 2025 22:23:15 -0500 Having an in-house regulatory team is really important, especially for companies with a lot of complex combination products. They know the company’s processes inside and out and can handle the mix of device and drug/biologic regulations more easily. That said,…   Read more»

]]> e9764fc20c077dc0bb0972053088e582 https://medicaldevicecourses.com/activity/p/30554/ Sun, 02 Feb 2025 22:20:30 -0500 Although I don’t have direct experience in managing medical device projects, I can imagine it’s quite a complex process. The combination of strict regulatory requirements, technological innovation, and the need to balance cost, time, and quality seems like a significant…   Read more»

]]> f2a1b677f017f49d004f78b89ed1cad5 https://medicaldevicecourses.com/activity/p/30553/ Sun, 02 Feb 2025 22:00:47 -0500 The FDA approves medical devices through two main pathways: PMA for high-risk Class III devices, requiring extensive clinical testing, and 510(k) for moderate-risk Class II devices, which must show similarity to an existing product. PMA is rigorous, costly, and time-consuming,…   Read more»

]]> 56a202fa3b2cb47d6b090d18df4a1ae1 https://medicaldevicecourses.com/activity/p/30481/ Mon, 27 Jan 2025 03:34:03 -0500 Although I don’t have direct experience working as a Project Manager, these are some things I have learned through my courses. Conflicts over opinions or work styles can definitely be tricky, but good communication and proactive problem-solving make a huge…   Read more»

]]> 9e3a49798ef3865eeaeeaba241102c09 https://medicaldevicecourses.com/activity/p/30480/ Mon, 27 Jan 2025 03:24:30 -0500 Although I don’t have direct experience managing medical device projects, my background in chemical engineering and biomedical engineering studies have given me insight into the challenges of balancing time, cost, and scope. From what I’ve learned, scope is often the…   Read more»

]]> b4be8e565cd896f591c4e9565d97426b https://medicaldevicecourses.com/activity/p/30479/ Mon, 27 Jan 2025 03:14:32 -0500 Hi Everyone, I’m currently exploring career opportunities in the medical device industry and am particularly curious about the role of a project manager. I have a background in Chemical Engineering and am pursuing a master’s in Biomedical Engineering. I am…   Read more»

]]> d8ddc19bd932dcb240f5085c23ae43f7 https://medicaldevicecourses.com/activity/p/30333/ Sun, 01 Dec 2024 23:17:00 -0500 When it comes to agreements, one of the most important things is making sure everyone knows what’s expected from the start. For example, in consulting contracts, being super clear about what needs to be done and by when is key….   Read more»

]]> 671fa293ca162691e46a4c3e9fd12c87 https://medicaldevicecourses.com/activity/p/30332/ Sun, 01 Dec 2024 23:07:23 -0500 Having a solid plan in place for emergencies is definitely a smart move. If something happened to me, I’d want a clear roadmap for how things should be handled—like managing deals and legal stuff—so the business keeps running smoothly. I’d…   Read more»

]]> 079a5135583e0ddf24f8d8c3459c394f https://medicaldevicecourses.com/activity/p/30331/ Sun, 01 Dec 2024 22:51:11 -0500 To strike a good balance between protecting sensitive information and being transparent when working with consultants, companies need a thoughtful approach. NDAs should be specific and focus on truly confidential details, avoiding overly broad terms that could get in the…   Read more»

]]> 03ccd8235245ae8374154376fa940189 https://medicaldevicecourses.com/activity/p/30180/ Sun, 17 Nov 2024 21:07:35 -0500 In manufacturing, risk management is all about catching potential issues early to keep things running smoothly and safely. While avoiding risks is a big focus, there are also other strategies like reducing risks and accepting them if necessary. One way…   Read more»

]]> 561fded3d2cff5be29d348a1d24d25f8 https://medicaldevicecourses.com/activity/p/30179/ Sun, 17 Nov 2024 21:04:00 -0500 A key but often overlooked part of risk management in medical devices is human factors engineering (HFE). While frameworks like ISO 14971 help address device risks, HFE focuses on how users interact with devices to avoid mistakes that could harm…   Read more»

]]> 93b5e39b73fe60c5d5b728d2c0d8737a https://medicaldevicecourses.com/activity/p/30178/ Sun, 17 Nov 2024 20:50:25 -0500 When developing medical devices, figuring out what level of risk is acceptable comes down to balancing patient safety, technology, and costs. It involves doing a risk-benefit analysis, applying the ALARP principle (reducing risk as much as reasonably possible), and using…   Read more»

]]> 16d02beceb7eef486fce3f5264c7df25 https://medicaldevicecourses.com/activity/p/30079/ Sat, 09 Nov 2024 20:48:47 -0500 Managing a big, complex Design History File (DHF) can definitely be tricky, but one good way to handle it is by keeping things organized. Breaking it down into clear sections that follow the product development process—like design inputs, outputs, verification,…   Read more»

]]> 2448d5d4d4e7e72d793fab6f29ba7ed6 https://medicaldevicecourses.com/activity/p/30078/ Sat, 09 Nov 2024 20:41:35 -0500 Design Transfer is a key part of moving from development to manufacturing, and there are a few ways companies can improve it to avoid production issues and keep quality up. First, making sure the design, quality, and manufacturing teams communicate…   Read more»

]]> 6f2bdf7cf6cfdd9f4bb364125ebf7649 https://medicaldevicecourses.com/activity/p/30077/ Sat, 09 Nov 2024 20:39:02 -0500 Design Controls under FDA’s 21 CFR Part 820.30 are all about making sure medical devices are developed with safety, effectiveness, and compliance in mind. They help keep things organized and reduce the risk of errors, ensuring that the design meets…   Read more»

]]> abd2be4dfb7f1298bf412c2a23ae64d2 https://medicaldevicecourses.com/activity/p/30021/ Mon, 04 Nov 2024 01:33:07 -0500 Great point! It makes sense that every design input should ideally have a corresponding output. Inputs set the foundation—they’re the requirements a device has to meet. In a perfect world, each input would lead to a specific output showing how…   Read more»

]]> 3465af0f69d4d7d0765f1e8b2f2e80b4 https://medicaldevicecourses.com/activity/p/30020/ Mon, 04 Nov 2024 01:28:34 -0500 You bring up a great point about validation—it’s all about making sure processes can reliably produce a product that meets specific standards. Defining clear success criteria upfront is key; without it, goals can shift, which wastes time, resources, and can…   Read more»

]]> 2bf6215b3284eccc4080c7fea3629d90 https://medicaldevicecourses.com/activity/p/30019/ Mon, 04 Nov 2024 01:10:47 -0500 You’ve nailed an important point about design controls—they’re all about making sure a medical device is safe and effective by following a structured process. By having these controls in place, manufacturers can catch potential issues early, which helps avoid expensive…   Read more»

]]> 49b056aea7377e194a5cec4ef2d67369 https://medicaldevicecourses.com/activity/p/29960/ Mon, 28 Oct 2024 02:18:06 -0400 One of the biggest challenges with multi-center clinical trials is keeping everyone on the same page. Since these trials are all about gathering a lot of data quickly, it’s super important to have clear expectations to ensure that all the…   Read more»

]]> 7e147aa773e741c61b32c5f032ea30c5 https://medicaldevicecourses.com/activity/p/29956/ Mon, 28 Oct 2024 01:21:11 -0400 Interestingly, researchers have made it easier to find clinical trials nearby and figure out what to expect if you participate. Clinical trials are crucial in medical research because they help ensure that treatments are safe and effective before the FDA…   Read more»

]]> 07e7181000cb0ac51711e77226066fbb https://medicaldevicecourses.com/activity/p/29955/ Mon, 28 Oct 2024 01:09:28 -0400 Clinical trials are so important for ensuring we develop safe and effective treatments. One treatment that comes to mind is carotid artery stenting (CAS) for patients with narrowed arteries in their necks. This procedure helps reduce the risk of stroke…   Read more»

]]> ecc5308db18b4b94ad5a4ef6ff997c1f https://medicaldevicecourses.com/activity/p/29898/ Mon, 21 Oct 2024 00:57:18 -0400 You’ve pointed out the connection between sales and marketing pretty well; they really do go hand in hand. Marketing does a solid job of drawing in customers through various channels like social media and email campaigns, which helps build brand…   Read more»

]]> ebdf221cc3dd8e369e58c1d3c6e246ff https://medicaldevicecourses.com/activity/p/29897/ Mon, 21 Oct 2024 00:52:37 -0400 You bring up a great point about the need for long-term customer connections. One effective way businesses can boost customer retention is by creating personalized experiences. Customers who feel understood by a brand are much more likely to stick around….   Read more»

]]> c1623a80c69cb119b1b3f21de50e1cc2 https://medicaldevicecourses.com/activity/p/29896/ Mon, 21 Oct 2024 00:48:33 -0400 Absolutely! Closing a sale is just the start; the real challenge is keeping customers around for the long haul. Businesses can really up their game by providing personalized experiences, staying connected with custom messages, and creating loyalty programs that reward…   Read more»

]]> 6244d8a15355af8ce77417a487c2d82a https://medicaldevicecourses.com/activity/p/29818/ Mon, 14 Oct 2024 00:43:42 -0400 You’ve got a good point about how corporate teams and research labs differ! In a corporate setting, having clear roles and hierarchies can really help with getting things done since everyone knows their responsibilities. But it can also stifle creativity…   Read more»

]]> 617fdffe0fa38af33d12586c74094e4a https://medicaldevicecourses.com/activity/p/29817/ Sun, 13 Oct 2024 23:24:35 -0400 An extra business course could really help engineering students, especially those looking to get into project management, product development, or even starting their own businesses. While NJIT’s engineering management course covers the basics, having a deeper understanding of things like…   Read more»

]]> 9fa556cd26920de0d6ed8123a7358eae https://medicaldevicecourses.com/activity/p/29816/ Sun, 13 Oct 2024 23:18:14 -0400 Regulatory agencies like the FDA and EMA act more like government service organizations than typical businesses. Their main job is to make sure medical products are safe and effective, and they fund this work through a mix of government budgets…   Read more»

]]> 7432737d779ca0352c12b4b8bd5ba600 https://medicaldevicecourses.com/activity/p/29741/ Sun, 06 Oct 2024 23:59:12 -0400 For Quality Assurance, two big things that come to mind are regulatory compliance and training. Sticking to regulations like ISO 13485 and FDA guidelines is a must in our industry. Using tools like document control software and compliance management systems…   Read more»

]]> 110374ad53cdb683e5b5115ef74794d3 https://medicaldevicecourses.com/activity/p/29740/ Sun, 06 Oct 2024 23:19:05 -0400 I don’t have much firsthand experience with root cause analysis (RCA), but I understand its importance in quality management, especially in the medical device industry where safety is a top priority. RCA is about analyzing to find the actual cause…   Read more»

]]> 86a23f082c8a411fbfe9bbe67bba5346 https://medicaldevicecourses.com/activity/p/29738/ Sun, 06 Oct 2024 22:14:04 -0400 Switching from one system to another, whether it’s going digital or moving between ERP/QMS platforms, comes with a lot of challenges, especially for teams like QA, QC, document control, and training. Data migration is a big deal because if something…   Read more»

]]> 49d6c5882d5dd000f72fd66b8cf51c87 https://medicaldevicecourses.com/activity/p/29617/ Mon, 23 Sep 2024 00:14:38 -0400 You made some really good points about the significance of using hydrogels in pre-clinical research! Another big plus is that hydrogels can be easily modified to release drugs in a controlled manner, making them ideal for studying how treatments can…   Read more»

]]> 607e97d0500d619edbd8b661a4848035 https://medicaldevicecourses.com/activity/p/29616/ Mon, 23 Sep 2024 00:04:18 -0400 You make a great point about the importance of choosing the right animal models in pre-clinical research, especially in neurology. This is because the brain and nervous system are so complex that it’s crucial to look for a specific species…   Read more»

]]> 999b4c90a9f500348b63e03985e0e665 https://medicaldevicecourses.com/activity/p/29547/ Mon, 16 Sep 2024 02:39:08 -0400 Tech tools have changed the game in project management. What apps or software do you use to keep your projects running smoothly? Are there any features that you find super useful? How do you choose the right tools, and how…   Read more»

]]> e60bf1be2c275eda30bf213645a95938 https://medicaldevicecourses.com/activity/p/29546/ Mon, 16 Sep 2024 02:21:20 -0400 Based on what we learned from the week 1 lecture, having a good plan and communication are key to avoiding stress. Breaking the project into smaller tasks and setting realistic deadlines could help avoid any last-minute issues. In addition, staying…   Read more»

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