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yg385
@yg385
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Joined: Sep 11, 2024
Last seen: Apr 27, 2026
Topics: 0 / Replies: 75
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RE: What are some ways Document Control can improve?

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 differen...

2 years ago
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RE: Issues with the Quality Department

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 in...

2 years ago
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RE: Regulatory Compliance and Quality Assurance

Ensuring a medical device is safe and acceptable per todays regulatory standards is a difficult task to tackle already; many companies and industries ...

2 years ago
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RE: Responses to Public Health Emergencies

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 pande...

2 years ago
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RE: Regulatory Department Functions

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 t...

2 years ago
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RE: Precision and Accuracy

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 mak...

2 years ago
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RE: Ethics of Animal Testing

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...

2 years ago
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RE: Challenges in Applying ISO 10993 Standards

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 ...

2 years ago
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RE: Ensuring Biocompatibility in Medical Devices

Maintaining biocompatibility of a medical device is a different process between a customer (Medical device design company) and a medical device manufa...

2 years ago
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RE: When Does It Makes Sense To Give Up On A Project?

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...

2 years ago
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RE: People in a Project

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 l...

2 years ago
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RE: Project Planning: How Much Detail is Enough?

@mk959 you provide really interesting perspective by saying you think it depends on the setting; I agree. Looking through several of the other replies...

2 years ago
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RE: Discussion Topic: Practical vs. Informational courses

@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...

2 years ago
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RE: Onsite or Remote (Work)

@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 t...

2 years ago
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RE: Onsite or Remote (Work)

@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...

2 years ago
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