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yg385 replied to the topic "Choosing A corporation" – 5 months, 3 weeks ago
@as934 , reading through the other posts, agree this point is not mentioned and is a good one to consider. Tying into this point, the type of corporation chosen also depends on the future intent of the individuals attempting to start this… Read more»
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yg385 replied to the topic "What are some ways Document Control can improve?" – 6 months ago
The biggest issue I’ve seen that people dislike when working in a manufacturing company is change. No one likes change or having to do things differently than what was deemed ‘acceptable’ in the past. This applies across any department in… Read more»
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yg385 replied to the topic "Issues with the Quality Department" – 6 months ago
Working in R&D in a medical device manufacturer, in the past I’ve noticed that the main issue with quality is that each QE may have a different interpretation for how something should be done. I.e. you’re filling out an operational… Read more»
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yg385 replied to the topic "Regulatory Compliance and Quality Assurance" – 6 months ago
Ensuring a medical device is safe and acceptable per todays regulatory standards is a difficult task to tackle already; many companies and industries take different, but often times similar approaches to doing this. While many others have mentioned regular inspections… Read more»
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yg385 replied to the topic "Responses to Public Health Emergencies" – 6 months, 1 week ago
Like they say, hindsight is always 20/20. The FDA could’ve handled the rollout of the vaccine much more effectively. But didn’t at the time as a pandemic of that scale and severity hadn’t been seen since the 1918 Influenza Pandemic-with… Read more»
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yg385 replied to the topic "Regulatory Department Functions" – 6 months, 1 week ago
Reading through the comments on here, I’m going to go against the grain here and say…post-market management is equally, if not even more important than the product development stage. Both are critical. However, in the product development stage, the ‘safety… Read more»
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yg385 replied to the topic "Precision and Accuracy" – 6 months, 1 week ago
To add onto this, precision and accuracy starts from the ‘ground-up’ on a medical device. By this I mean that each and every single component that make up the medical device is evaluated separately to ensure the overall assembled device… Read more»
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yg385 replied to the topic "Ethics of Animal Testing" – 6 months, 2 weeks ago
Testing on animals is a very contentious topic…while it would feel morally better to stand on the side of being against animal testing, I can’t take that stance. As many others have mentioned, I do believe there can be a… Read more»
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yg385 replied to the topic "Challenges in Applying ISO 10993 Standards" – 6 months, 2 weeks ago
This is a good post and important question to ask. Looking through several other posts, I see key issues that need to be considered like expansion on time and costs, using a computer model, material characterization, and how a company… Read more»
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yg385 replied to the topic "Ensuring Biocompatibility in Medical Devices" – 6 months, 2 weeks ago
Maintaining biocompatibility of a medical device is a different process between a customer (Medical device design company) and a medical device manufacturer. Several of the other posts have made good points in discussing specific methods for aiding in biocompatibility on… Read more»
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yg385 replied to the topic "When Does It Makes Sense To Give Up On A Project?" – 6 months, 3 weeks ago
This is a very good question as of course, there will always be a ‘failing project’ that companies encounter at some point. To answer the question, I’d say yes, this kind of decision should be decided even well before the… Read more»
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yg385 replied to the topic "People in a Project" – 6 months, 3 weeks ago
Reading your post and replies I want to say-yes true, it is important to understand those in your team and be able to work with them. However, I’d like to emphasize a really important point. Most of the time you’ll have… Read more»
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yg385 replied to the topic "Project Planning: How Much Detail is Enough?" – 6 months, 3 weeks ago
@mk959 you provide really interesting perspective by saying you think it depends on the setting; I agree. Looking through several of the other replies in this thread, I noticed that the general consensus seemed to be ‘No there’s no such… Read more»
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yg385 replied to the topic "Discussion Topic: Practical vs. Informational courses" – 6 months, 3 weeks ago
@asimbana , completely agree. I find it very interesting going through the comments and seeing a slight divide, in that many that are already out of college agree that more practical courses would be better, and some in college are… Read more»
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yg385 replied to the topic "Onsite or Remote (Work)" – 6 months, 3 weeks ago
@giang , It’s pretty interesting that you brought up that your bf’s job has a “collaboration week”. It brings up the good point in a way that one of the cons with remote work, is that that sense of team… Read more»
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yg385 replied to the topic "Onsite or Remote (Work)" – 6 months, 3 weeks ago
@bsk32 , completely agree. I don’t think its really as simple as remote or fully in-person when it comes to many technical fields especially. The type of engineer you may be for example will even impact whether you’re able to… Read more»
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yg385 became a registered member 6 months, 3 weeks ago