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bms56
@bruno-seixal
Active Member
Joined: Sep 1, 2025
Last seen: Sep 28, 2025
Topics: 0 / Replies: 9
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RE: Punishment for Failing FDA Audits

From what I understand, the FDA usually distinguishes between major and minor nonconformances. A couple of small errors in labeling or paperwork that ...

6 days ago
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RE: Discussion Topic: Make a few, sell a few

I think a physician who wants to create their own medical device would face a lot of challenges, even though their medical expertise would give them a...

6 days ago
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RE: Does the FDA guarantee safety?

Sometimes I get surprised by how the FDA works as approval doesn't mean a drug is completely safe, it just means the benefits outweigh the risks for m...

6 days ago
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RE: Why Is Pre-clinical Research So Important Before Testing on Humans?

I agree that pre-clinical research is a critical safety checkpoint in medical device development as I am sure most would. Using human subjects to imme...

2 weeks ago
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RE: Ethics of Animal Testing

Pre-clinical studies are critical for developing safe and effective medications, devices, etc, but ethics no matter the topic can ever be ignored. Ani...

2 weeks ago
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RE: Research for the Fututre or Now?

If i were to pick only one option I would pick the results of my research to be applied right away to help the people of my generation, but that's not...

2 weeks ago
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RE: Teamwork in Projects

To answer the question on what the biggest challenge in teamwork is I would choose people not doing their share of the work. Members of a team disagre...

3 weeks ago
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RE: Milestones Missed: Failure or Success?

I believe that missing a milestone in a project doesn't automatically mean failure, but it depends on the type of milestone missed as it can actually ...

3 weeks ago
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RE: Which feature is the most important for a project manager?

I think that the most important feature for a project manager is definitely effective communication. A manager acts as the central point of contact be...

3 weeks ago