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dk555
@dk555
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Joined: Sep 5, 2024
Last seen: Apr 13, 2025
Topics: 1 / Replies: 72
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RE: Effective Use of Design Transfer in Streamlining Production for Medical Devices

The Design Transfer team ensures that all relevant design information is provided to production teams. They consolidate every critical detail, from ma...

5 months ago
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RE: Different Standards for Design Controls

There are many factors that go into deciding how to interpret these guidelines. A few that I can think of include Regulatory Strategy and Risk Toleran...

6 months ago
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RE: Validation Study Success Defined

I think that the steps taken to define success criteria have been more or less clearly represented by previous responses in this discussion thread. I'...

6 months ago
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RE: Benefits of Software Validation

A few more benefits of software validation include but are not limited to:Extended Device Longevity and Lower Maintenance Costs: Validated software is...

6 months ago
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RE: Clinical Research Studies

Participating in a clinical trial is a meaningful way to contribute to the development of new treatments potentially shaping the future of medicine. M...

6 months ago
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RE: What is not seen in Clinical Trials?

While clinical trials are critical for evaluating the safety and efficacy of a product, they often lack in participant diversity and the real-world co...

6 months ago
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RE: Handling Adverse Events in Trials

Effective coordination and communication are essential when adverse events occur in clinical trials. Maintaining clarity between investigators, sponso...

6 months ago
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RE: External Environment Factors

Contingency plans are certainly important for companies to avoid being affected by external factors. Specifically in terms of weather, it is important...

6 months ago
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RE: Is entering a career in sales worth it?

I certainly agree that it depends on the type of person you are. To be successful in sales, there has to be some sort of extroverted nature that you c...

6 months ago
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RE: Business Minor/Major

I think the answer to this question is really based on where you want your career to end up. I have always been interested in people management. Befor...

6 months ago
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RE: S or C Corperation

When deciding between going with an S-Corp or C-Corp structure, one must carefully weigh the benefits of tax savings against broader opportunities suc...

6 months ago
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RE: Business in Regulatory Agencies

Regulatory agencies such as the FDA and EMA, while governmental agencies, tend to operate similarly to non-profit organizations. They do not generate ...

6 months ago
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RE: Differences in team dynamics and leadership styles between corporations and research labs

I think this is a great topic to dive deeper into! I have experience in both, working in a research lab during my undergraduate studies and the corpor...

6 months ago
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RE: Experience in Quality Assurance and Quality Control

I had a role in a Performance Evaluation R&D Group during one of my Co-Ops. Although this role was in the R&D field, being performance evaluat...

6 months ago
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RE: Switching Between Systems - Effect on QA/QC

Cybersecurity is certainly a vital consideration when migrating from paper-based to digital systems. Along with cybersecurity, another important facto...

6 months ago
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