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shreya
@shreya
Active Member
Joined: Sep 9, 2025
Last seen: Sep 28, 2025
Topics: 0 / Replies: 12
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RE: Punishment for Failing FDA Audits

One angle I think hasn’t been mentioned yet is how minor errors can actually reveal the “compliance culture” of a company. Even if labeling or paperwo...

3 days ago
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RE: Are Regulations Helping Innovation or Slowing It Down?

You both raise great arguments regarding how, depending on the company's resources, the FDA can either encourage or impede innovation. I agree that fu...

3 days ago
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RE: How to start career in regulatory area (no industry exp yet)

I get what you mean about regulatory sounding repetitive, but I think there’s more to it than just paperwork. If a company wants to sell in different ...

3 days ago
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RE: The Advantages and Disadvantages of Being Overqualified

I agree that being overqualified can open doors for promotions or leadership opportunities, but I think one challenge that doesn’t get mentioned enoug...

1 week ago
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RE: Bridging Design Innovation with Regulatory Compliance in Early Stages of Device Development

One aspect that is sometimes disregarded in my opinion, is how rules can sometimes really influence innovation rather than only restrict it. Human fac...

1 week ago
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RE: Key factors to consider while selecting appropriate animal models for pre-clinical research to develop therapies for neurological disorders.

I agree that species similarity and ethical considerations are central, but I think another key factor is how well an animal model can replicate not j...

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

I agree with both of you that pre-clinical research protects patients and eventually saves time and money, but I believe that their credibility-buildi...

1 week ago
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RE: What Is the Biggest Challenge in Pre-clinical Device Development?

I agree that pre-clinical work frequently entails a lot of moving parts before the "real science" ever begins, which makes the organizational and appr...

1 week ago
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RE: Managing Team Opinions While Sticking to Decisions

The emotional intelligence aspect of leadership in these circumstances is, in my opinion, something that is important. If team members feel underappre...

2 weeks ago
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RE: Quality and Risk Management in the Project Life Cycle

I agree that quality assurance and risk management depend heavily on documentation, monitoring, and audits, but I believe that adaptability is another...

2 weeks ago
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RE: Manager Vs Engineering

In the creation of medical devices, engineers and managers have complimentary roles, and I wholeheartedly agree. My personal experience with research ...

2 weeks ago
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RE: Academia vs. Industry: Why I Prefer Industry

I agree with your points about academia and industry, each offering very different kinds of challenges and rewards. Based on my personal research, I'v...

3 weeks ago