https://medicaldevicecourses.com/members/imarah-ar/activity/ Activity feed for imarah.AR. Fri, 24 Apr 2026 21:48:21 -0400 https://buddypress.org/?v= en-US 30 hourly 2 2bdc419c0e9a90eee5a623422b0ff7a5 https://medicaldevicecourses.com/activity/p/47152/ Sun, 19 Apr 2026 17:49:20 -0400 From my perspective, the best way a project manager can make an informed decision between crashing and fast tracking is by carefully evaluating the trade-offs in terms of cost, risk, and impact on quality before making a move. I would…   Read more»

]]> 5c4981faab48c701a92fa34154602d90 https://medicaldevicecourses.com/activity/p/47147/ Sun, 19 Apr 2026 16:48:02 -0400 From my experience, I’ve definitely been part of projects that suffered from scope creep, especially in group assignments where new ideas kept getting added without fully considering the original plan. One example was a team project where we started with…   Read more»

]]> 1f497232b4ec265443fa329636456621 https://medicaldevicecourses.com/activity/p/47145/ Sun, 19 Apr 2026 16:37:21 -0400 From my perspective, it is definitely worth taking some time, even if deadlines are tight, to make sure everyone has a general understanding of what the other teams are doing. I’ve seen how projects can fall apart or become inefficient…   Read more»

]]> ba45b0cd68acb1f9e68b636efe5e0938 https://medicaldevicecourses.com/activity/p/46344/ Sat, 11 Apr 2026 22:32:54 -0400 I think in a situation where a project is ultimately successful but experiences delays or cost increases, the evaluation of personnel should reflect both the positive outcomes and the negative challenges rather than focusing on just one side. The success…   Read more»

]]> 6f9317bd6d44216cd722f5bdc24e3764 https://medicaldevicecourses.com/activity/p/46338/ Sat, 11 Apr 2026 20:55:21 -0400 I think project managers should consider both internal and external hiring because each has its own advantages, but it really depends on the situation. Hiring from within the company can be beneficial since those employees already understand the company culture,…   Read more»

]]> be9af17a88109592e6227cb63c935bc1 https://medicaldevicecourses.com/activity/p/46336/ Sat, 11 Apr 2026 20:50:25 -0400 I honestly found this situation uncomfortable because I can see how easy it is to feel pressured into signing off on something before it is fully ready, especially when deadlines and management expectations are involved. I haven’t personally approved a…   Read more»

]]> 9112ed464825ffe37a3c20fcda09c2d5 https://medicaldevicecourses.com/activity/p/45137/ Mon, 30 Mar 2026 00:52:25 -0400 When unexpected delays happen that are out of the team’s control, I think the best approach is to stay flexible and focus on what can still be done while waiting on the blocked task. I have experienced situations where progress…   Read more»

]]> 048428176376bed884a04098f0e4083c https://medicaldevicecourses.com/activity/p/45136/ Mon, 30 Mar 2026 00:47:38 -0400 From my experience, strong communication through status review meetings is the most important because it keeps everyone aligned and aware of progress, risks, and next steps. I have been part of a team where the project manager did not run…   Read more»

]]> 843ced17b0f76ed2c488a20ab8193bba https://medicaldevicecourses.com/activity/p/45135/ Mon, 30 Mar 2026 00:42:34 -0400 I think design transfer is more than just handing off a product. It is about making sure the manufacturing team is fully prepared. Clear documentation, like work instructions, specifications, and testing procedures, is essential so nothing is misunderstood during production….   Read more»

]]> 032b176fee8c10b8746a6b381cd6c4da https://medicaldevicecourses.com/activity/p/43522/ Fri, 13 Mar 2026 03:35:27 -0400 Late stage decisions in development require carefully evaluating both the technical problem and the overall impact on the project. During the executing phase, teams are expected to monitor progress and implement corrective actions or change requests when something does not…   Read more»

]]> 3e816784f08a1666eccfd548312e67a3 https://medicaldevicecourses.com/activity/p/43521/ Fri, 13 Mar 2026 03:33:02 -0400 From my perspective, one of the biggest challenges in scope verification for medical device projects is making sure that everyone clearly understands the project requirements from the beginning. If the scope is not well documented or stakeholders are not regularly…   Read more»

]]> 0cbaaa0bc03f21aa3684987b9a4970d0 https://medicaldevicecourses.com/activity/p/43520/ Fri, 13 Mar 2026 03:29:44 -0400 The most effective method for organizations to achieve both communication and productivity goals is through structured implementation of meetings and emails. The information distribution process plays a critical role in project management execution because teams require project information to be…   Read more»

]]> cc23761c8bd387f75d15376a5b361106 https://medicaldevicecourses.com/activity/p/43289/ Tue, 10 Mar 2026 16:43:37 -0400 One time I experienced this was during a group project where our team had a set timeline with specific milestones we needed to complete each week. We ended up missing one of our milestones because the task took longer than…   Read more»

]]> f32ac9efe83478570252536fc78e43a7 https://medicaldevicecourses.com/activity/p/43288/ Tue, 10 Mar 2026 16:42:29 -0400 In my opinion, the most important phase in the project process is the planning phase. I believe this phase is crucial because it sets the foundation for everything that follows in the project. During planning, the goals, scope, timeline, and…   Read more»

]]> 4e9377e1a64097ab28ebe0aaf700867a https://medicaldevicecourses.com/activity/p/43287/ Tue, 10 Mar 2026 16:41:02 -0400 Hi everyone! Here is my LinkedIn page. Imarah Abdur Rasheed | LinkedIn (https://www.linkedin.com/in/imarahar/) I am currently a student at NJIT and look forward to connecting with you all!    Imarah Abdur Rasheed      

]]> 311b8550445a1360f88c3692fbc095bc https://medicaldevicecourses.com/activity/p/41451/ Sun, 22 Feb 2026 05:01:06 -0500 I would look to “Organizational Process Assets” to find procedures, guidelines, and existing information within the company. These assets include documented processes, policies, templates, lessons learned, and historical project information that help guide how projects are initiated and managed. They…   Read more»

]]> 0eeb1765af3f4c1c9c6788f0cdf076da https://medicaldevicecourses.com/activity/p/41447/ Sun, 22 Feb 2026 04:51:58 -0500 As a project manager, my approach to handling personal conflicts between team members is to stay neutral and focus on how the situation affects the project, not the individuals involved. I would first address the issue early and privately by…   Read more»

]]> 26cffdb693bb229ef8c97c28f6c87cfd https://medicaldevicecourses.com/activity/p/41445/ Sun, 22 Feb 2026 04:50:00 -0500 I don’t think employees, group leads, or project managers should automatically be penalized for going over a deadline or budget, because so many factors in a project are outside of any one person’s control. Things like supply chain delays, rising…   Read more»

]]> 4efe683221db39799a42c173d8100eb6 https://medicaldevicecourses.com/activity/p/40716/ Mon, 16 Feb 2026 02:38:58 -0500 I believe regulatory considerations must be integrated from the very beginning of a project rather than treated as a final checkpoint before submission. As a project manager, I would involve regulatory experts at the concept and feasibility stage so they…   Read more»

]]> c6511c4b5fb5beba75cfce2b325f4356 https://medicaldevicecourses.com/activity/p/40715/ Mon, 16 Feb 2026 02:33:27 -0500 If I were allowed to change the Design Specification Document, my approach would shift from simply adjusting the verification test to questioning whether the underlying design requirements truly reflect real-world use conditions and patient safety. While it might be tempting…   Read more»

]]> b9adf25bf90066fab2f5184566167de8 https://medicaldevicecourses.com/activity/p/40714/ Mon, 16 Feb 2026 02:28:04 -0500 As the project manager for a Class III bio-absorbable vascular stent, I would see the animal study results as critical data rather than a setback, and I would pause the original strategy to reassess whether dissolving faster truly aligns with…   Read more»

]]> fa610ab617d749b333baae101072264e https://medicaldevicecourses.com/activity/p/40710/ Mon, 16 Feb 2026 02:23:25 -0500 As the project manager for a Class I bio-absorbable vascular stent, I would see the animal study results as critical data rather than a setback, and I would pause the original strategy to reassess whether dissolving faster truly aligns with…   Read more»

]]> 08939cf54862c76f861f58d603a373de https://medicaldevicecourses.com/activity/p/39892/ Mon, 09 Feb 2026 02:06:50 -0500 I think the most important responsibility of the FDA is ensuring the safety of drugs and medical products before they reach the public. This is important because people rely on medications and medical devices to improve or protect their health,…   Read more»

]]> 1a662a5098a64f221f42b065ef333b73 https://medicaldevicecourses.com/activity/p/39889/ Mon, 09 Feb 2026 02:01:36 -0500 I think both small and large teams have their pros and cons. Personally, I prefer working in a small team because it’s easier to communicate, stay organized, and make decisions without too much back-and-forth. I also find that working with…   Read more»

]]> c29ff7e66047e6af79677ff30858993f https://medicaldevicecourses.com/activity/p/39880/ Mon, 09 Feb 2026 00:59:38 -0500 I agree that internal and external factors can really shorten or extend a product’s life cycle, especially in tech-driven fields like medical devices. In addition to verification and validation, I think tools like risk management (such as hazard analysis), post-market…   Read more»

]]> 442f6df5f6ee802ea6f3c39395b5e268 https://medicaldevicecourses.com/activity/p/37223/ Mon, 26 Jan 2026 22:07:29 -0500 @ms2768 I think your perspective is really interesting, especially since you’ve experienced both fully in-person work during the pandemic and now a hybrid setup. I agree with you that in-person meetings often feel more productive because people are less likely…   Read more»

]]> e89f45b0ef7f991518f50f77cd9905cb https://medicaldevicecourses.com/activity/p/37222/ Mon, 26 Jan 2026 22:07:16 -0500 9b44a7f2acafabb2675d0bc4a5a5b7e1 https://medicaldevicecourses.com/activity/p/37221/ Mon, 26 Jan 2026 22:06:07 -0500 I would prefer to work under a project manager who communicates mainly in person because face-to-face interaction makes expectations clearer and helps prevent misunderstandings. Being able to read body language and tone also helps build trust and makes feedback feel…   Read more»

]]> 1a9b6248765f574edf617a298aadd489 https://medicaldevicecourses.com/activity/p/37218/ Mon, 26 Jan 2026 21:45:34 -0500 I prefer working in a small team because it’s easier to communicate, stay organized, and make decisions without things getting slowed down. Everyone’s role is usually clearer, and it’s harder for people to get lost or disengaged. That said, I…   Read more»

]]> 57bf1fabd8ad31608ae2d1cde04d21b4 https://medicaldevicecourses.com/activity/p/33617/ Tue, 11 Nov 2025 03:44:07 -0500 In past projects, I’ve used brainstorming and the Failure Mode and Effects Analysis (FMEA) method the most. Brainstorming is great for quickly generating ideas and identifying possible risks from different perspectives, but I find FMEA to be the most beneficial…   Read more»

]]> 3445649b07fab1be4882f99e8e8527a3 https://medicaldevicecourses.com/activity/p/33616/ Tue, 11 Nov 2025 03:32:54 -0500 At my previous internship, I learned how easily hazards can turn into serious situations if not managed properly. For example, imagine working at a company called MedTech Labs that develops diagnostic equipment. During testing, a technician accidentally spills a sample…   Read more»

]]> 5fafe2b6eba546fefdb9a5fa442ad914 https://medicaldevicecourses.com/activity/p/33615/ Tue, 11 Nov 2025 03:31:42 -0500 I definitely believe risk management is an essential part of the planning phase. It’s not a waste of time or money; it’s actually a smart investment that can prevent much bigger losses later on. By identifying potential risks early, teams…   Read more»

]]> bb8700afcea8ac92a105069ed9727a22 https://medicaldevicecourses.com/activity/p/33585/ Mon, 10 Nov 2025 01:34:28 -0500 I think the four columns in the Design Matrix, inputs, specifications, validation, and verification, provide a strong foundation, but they might not be enough to capture the full scope of the design process. I would recommend adding columns for risk…   Read more»

]]> 4a492689ac654b16c301c58c42205207 https://medicaldevicecourses.com/activity/p/33584/ Mon, 10 Nov 2025 01:32:25 -0500 I think our current design control systems have definitely come a long way since the Therac-25 incident, but I’m not sure they’re strong enough to completely prevent a modern “Therac moment,” especially with the rise of AI-driven devices. Standards like…   Read more»

]]> 697a110a1f080ef7a0ec45f7c4bac42d https://medicaldevicecourses.com/activity/p/33583/ Mon, 10 Nov 2025 01:28:04 -0500 I agree that product development is an evolutionary process that requires careful control and documentation to maintain quality. From my perspective, design control plays a critical role in ensuring that any modifications made to a device are intentional and traceable….   Read more»

]]> abdee66b00f2b1e5f67126235b91ac0a https://medicaldevicecourses.com/activity/p/33365/ Wed, 29 Oct 2025 20:20:40 -0400 Design control plays a huge role in developing safe and effective medical devices, but problems can definitely arise when it isn’t followed properly. If design inputs aren’t well-defined or don’t clearly connect to user needs, the product might end up…   Read more»

]]> b6bdb3b8fd6b8d71c904176f7ba69cca https://medicaldevicecourses.com/activity/p/33363/ Wed, 29 Oct 2025 20:18:18 -0400 I agree that catching issues before verification officially starts is the best case, because once the verification protocol and reports are underway, going back to revise the DID or DSD can slow everything down. But I personally don’t think companies…   Read more»

]]> 71a83afb744c9482bfdfb146e96a6d36 https://medicaldevicecourses.com/activity/p/33360/ Wed, 29 Oct 2025 20:15:32 -0400 I was thinking about this too! From what Dr. Simon explained, design verification is all about making sure our design outputs match the design inputs, and design validation checks that those inputs truly support the user’s needs. I do think…   Read more»

]]> 1eb17f8591a34a67d6da5ae58cb9654e https://medicaldevicecourses.com/activity/p/33275/ Fri, 24 Oct 2025 04:09:13 -0400 I really like your choice of wanting to be a Clinical Investigator. Investigators have a key responsibility in clinical research; they not only enroll and treat subjects but also make sure informed consent is obtained and that adverse events (AEs)…   Read more»

]]> b695bfb968506794e3357127a75b6d0e https://medicaldevicecourses.com/activity/p/33274/ Fri, 24 Oct 2025 04:05:58 -0400 I see what you mean; it might seem like a single-blind study should be enough. However, according to this week’s notes, bias can occur not only from the patient but also from the investigator. In a double-blind study, both the…   Read more»

]]> 38c3d1f9005d07a05eca01c83d3845e1 https://medicaldevicecourses.com/activity/p/33273/ Fri, 24 Oct 2025 04:02:47 -0400 I agree that clinical studies are essential despite their risks. According to the Week 5 slides, clinical research is the only way to determine how a medical product, device, or drug truly works in humans, since not all results from…   Read more»

]]> e3458cfdbc6a1a19485b390ada0d9040 https://medicaldevicecourses.com/activity/p/33221/ Sun, 19 Oct 2025 15:55:01 -0400 The FDA’s dual mission to ensure product safety while also “helping to speed innovations” creates a necessary but challenging balance. While the agency’s rigorous review process can seem slow, it is rooted in historical public health disasters, such as a…   Read more»

]]> 386be18b7f1cfbd95c5a96516948ef50 https://medicaldevicecourses.com/activity/p/33220/ Sun, 19 Oct 2025 15:54:59 -0400 I agree that the responsibility for medical product recalls is a shared one, and your points about Vioxx and the Philips CPAP machines are great examples of how things can go wrong after approval. I think it’s crucial to see…   Read more»

]]> ae9df6f05378e20218731dc49ed81d98 https://medicaldevicecourses.com/activity/p/33219/ Sun, 19 Oct 2025 15:54:56 -0400 FDA approval is not a guarantee of absolute safety, but rather an assurance that a product’s scientifically-proven benefits for its intended use outweigh its known risks. The extensive list of side effects in drug commercials is a direct result of…   Read more»

]]> 013863a43d014758964695120196f75f https://medicaldevicecourses.com/activity/p/33218/ Sun, 19 Oct 2025 15:54:54 -0400 Quality Assurance (QA) and Quality Control (QC) are fundamentally different, leading to distinct career paths and training. QA is preventive and process-oriented, focusing on creating and managing the overall system to ensure quality is built in from the start 1;…   Read more»

]]> 7c415cca82082d52ec8ca3180c273f3f https://medicaldevicecourses.com/activity/p/33217/ Sun, 19 Oct 2025 15:54:41 -0400 You’ve perfectly captured the essential difference between the two roles. While both QA and QC are absolutely critical, I believe the biggest impact on patient safety comes from prioritizing resources in Quality Assurance (QA). The slides define QA as “Preventive…   Read more»

]]> 3b46da3340aab615d3a66039a12a8634 https://medicaldevicecourses.com/activity/p/33216/ Sun, 19 Oct 2025 15:54:39 -0400 To keep QA efficient with new technologies like AI, we should enhance foundational principles rather than replace them. By applying adaptive frameworks like the “Plan, Do, Check, Act” (PDCA) cycle, new technologies become powerful tools within the existing quality system….   Read more»

]]> 75981365aedbb4713669dbb248e334ae https://medicaldevicecourses.com/activity/p/33213/ Sun, 19 Oct 2025 15:54:31 -0400 Corporate teams often have structured roles and hierarchies that make them more productive by keeping goals clear and responsibilities organized, as shown in the slides for this week on how corporations operate with defined leadership roles like CEO or CFO….   Read more»

]]> c386e8c0aa622425abc9d3ed79e7c4de https://medicaldevicecourses.com/activity/p/33212/ Sun, 19 Oct 2025 15:54:28 -0400 I think both improving patient care delivery and innovating with new technology are equally important for physicians who want to start their own practice. Telehealth and clinics help expand access to care and make treatment more convenient, while new devices…   Read more»

]]> 00fa1f2c439923c3059853d24c583064 https://medicaldevicecourses.com/activity/p/33211/ Sun, 19 Oct 2025 15:54:26 -0400 If I had the chance to build my own business, I would start by identifying a problem I’m passionate about solving and then create a plan around that. The biggest considerations would be understanding my target audience, managing finances carefully,…   Read more»

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