yg385

Forum Replies Created

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 differently than what was deemed 'acceptable' in the past....

In forum Quality Control and Quality Assurance

2 years ago
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 interpretation for how something should be done. I.e...

In forum Quality Control and Quality Assurance

2 years ago
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 take different, but often times similar approaches...

In forum Quality Control and Quality Assurance

2 years ago
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 pandemic of that scale and severity hadn't been seen si...

In forum Regulatory Basics for Medical Devices

2 years ago
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 than the product development stage. Both are critic...

In forum Regulatory Basics for Medical Devices

2 years ago
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 make up the medical device is evaluated separately to...

In forum Regulatory Basics for Medical Devices

2 years ago
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 that stance. As many others have mentioned, I do ...

In forum Pre-clinical Device Development

2 years ago
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 time and costs, using a computer model, material c...

In forum Pre-clinical Device Development

2 years ago
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 manufacturer. Several of the other posts have made good ...

In forum Pre-clinical Device Development

2 years ago
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'd say yes, this kind of decision should be decide...

In forum Intro to Project Management

2 years ago
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 like to emphasize a really important point. Most of t...

In forum Intro to Project Management

2 years ago
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 in this thread, I noticed that the general consen...

In forum Intro to Project Management

2 years ago
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 college agree that more practical courses would be ...

In forum Introduction to Medical Device Development

2 years ago
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 the cons with remote work, is that that sense of te...

In forum Introduction to Medical Device Development

2 years ago
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 of engineer you may be for example will even impa...

In forum Introduction to Medical Device Development

2 years ago
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