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Phoenix08 replied to the topic "Perception of QA/QC" – 1 month, 2 weeks ago
I concur with your statement regarding the importance of QA/QC in safeguarding both patients and the organization. I particularly liked your statement about documentation because quality is not just about identifying defective products; it is also about ensuring that each… Read more»
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Phoenix08 posted a new topic "Should AI-Based Medical Devices Require the Same Regulatory Approach as Traditional Medical Devices ?" – 1 month, 3 weeks ago
With the growing prevalence of artificial intelligence in medical devices, an intriguing question about the regulation of such devices arises. With traditional medical devices, companies have a fixed design and performance profile from the get-go, making it easier to test… Read more»
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Phoenix08 replied to the topic "Punishment for Failing FDA Audits" – 1 month, 3 weeks ago
I believe the intensity of the mistake and the corporation’s reaction to it are both important. A small problem with labeling or documentation may not have a direct impact on the safety and effectiveness of the Class III device; nevertheless,… Read more»
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Phoenix08 replied to the topic "FDA biased?" – 1 month, 3 weeks ago
Your worries about possible bias are reasonable, mainly because the FDA receives some funding for its operations from user fees collected from companies wishing to get their products approved by the agency. Yet, I believe that just because the FDA… Read more»
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Phoenix08 replied to the topic "Deciding How to Perform Research in Industry" – 1 month, 3 weeks ago
To manage a preclinical research project, I would need to take into consideration the complexity of the study, resources available, timelines imposed, and budget limitations. An in-house lab would be favorable in projects where the testing process has to be… Read more»
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Phoenix08 posted a new topic "From Pre-Clinical Research to Human Trials: When Is the Evidence Enough ?" – 1 month, 3 weeks ago
How do researches determine whether a new medical device, drug, or technology has sufficient justification to proceed from the laboratory and animal studies to human clinical trials ? Although more testing can contribute to safety, it can also consume a… Read more»
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Phoenix08 replied to the topic "Pre-Clinical Research: Academia(Passion) or Industry(Money)?" – 1 month, 3 weeks ago
Funding is vital when it comes to pushing pre-clinical research; this is so because of the high costs of equipment, the lengthy periods of research, and the fact that much testing must be done. The industry has an advantage when… Read more»
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Phoenix08 posted a new topic "Pressure vs. Safety: A Project Manager’s Toughest Decision" – 2 months ago
When a technical or regulatory problem arises in medical device development, how should project managers weigh the importance of deadlines for a project’s completion against patient safety? While some industries may put pressure on project managers to continue working to… Read more»
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Phoenix08 replied to the topic "Manager Vs Engineering" – 2 months ago
I also believe that clarity among engineers and managers is essential, especially in the development of medical devices since safety should not be jeopardized for the sake of deadlines. I believe that an ideal team is one that is cross-functional,… Read more»
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Phoenix08 replied to the topic "Multiple Project Managers for one project" – 2 months ago
Although I haven’t worked first-hand along with multiple project managers, I do believe that this could be a practical method for complex and large projects. Having managers doing different tasks allows everyone to pay more attention to their own responsibilities… Read more»
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Phoenix08 replied to the topic "Experience vs Education" – 2 months, 1 week ago
I concur that being well-rounded and feeling overburdened are two different things. While professional experience is valuable, students may become burned out if they are expected to manage a full course load while working long hours. In my opinion, employers… Read more»
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Phoenix08 replied to the topic "Academia vs. Industry: Why I Prefer Industry" – 2 months, 1 week ago
I would choose industry over academia because my long term interest is in seeing how biomedical engineering knowledge moves beyond research and becomes something that can actually be used in healthcare. Academia offers an excellent environment for developing new knowledge… Read more»
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Phoenix08 posted a new topic "Redesigning Medical Devices" – 2 months, 1 week ago
