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Mirna Cheikhali replied to the topic "Making Design Reviews Work in Medical Devices" – 1 week, 4 days ago
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»
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Mirna Cheikhali replied to the topic "Challenges of Using SV and CV in Medical Device Project Management" – 1 week, 4 days ago
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»
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Mirna Cheikhali replied to the topic "The Impact of Earned Value Management (EVM) on Project Budgeting" – 1 week, 4 days ago
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»
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Mirna Cheikhali replied to the topic "Identifying the Critical Path – Preventing Project Delays" – 1 month, 3 weeks ago
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»
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Mirna Cheikhali replied to the topic "Project Management Knowledge Areas" – 1 month, 3 weeks ago
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»
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Mirna Cheikhali replied to the topic "Integration of KA in Project Scope Management" – 1 month, 3 weeks ago
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»
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Mirna Cheikhali replied to the topic "Difficulty of Changes" – 2 months ago
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»
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Mirna Cheikhali replied to the topic "Different Types of Risks in a Project" – 2 months ago
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»
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Mirna Cheikhali replied to the topic "Integration of KA in Project Scope Management" – 2 months ago
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»
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Mirna Cheikhali replied to the topic "How Frequent Design Reviews Can Improve Medical Device Quality and Reduce Failures" – 2 months, 2 weeks ago
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»
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Mirna Cheikhali replied to the topic "Design Verification Failures" – 2 months, 2 weeks ago
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»
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Mirna Cheikhali replied to the topic "The Role of Regulatory Strategy in Combination Product Development" – 2 months, 3 weeks ago
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»
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Mirna Cheikhali replied to the topic "Role of Project Management in Medical Device Development" – 2 months, 3 weeks ago
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»
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Mirna Cheikhali replied to the topic "Pre-market Approval (PMA) vs. 510(k)" – 2 months, 3 weeks ago
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»
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Mirna Cheikhali replied to the topic "Handling Conflicts Among Team Members Effectively" – 2 months, 4 weeks ago
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»
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Mirna Cheikhali replied to the topic "Balancing time, cost and scope in project management" – 2 months, 4 weeks ago
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»
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Mirna Cheikhali posted a new topic "Seeking Insights on working as a Project Manager in the Medical Device Field" – 2 months, 4 weeks ago
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»
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Mirna Cheikhali replied to the topic "Legal Agreements in Effective Collaboration" – 4 months, 3 weeks ago
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»
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Mirna Cheikhali replied to the topic "Company Insurance" – 4 months, 3 weeks ago
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»
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Mirna Cheikhali replied to the topic "Confidentiality and Transparency in Consulting Agreements" – 4 months, 3 weeks ago
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»
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