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DarshP
@darshp
Eminent Member
Joined: Sep 8, 2025
Last seen: Nov 2, 2025
Topics: 0 / Replies: 30
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RE: Emerging technologies and QA

Specifically focusing on AI, it could greatly impact the jobs of QA individuals and aid them in making more effective SOPs, validation documents, etc....

1 month ago
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RE: What’s the Real Difference Between Quality Control and Quality Assurance?

At the end of the day, both QC and QA are crucial to the success of a product line and a company in general. If a device is not properly prepared, man...

1 month ago
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RE: Can Too Much Quality Control Slow Down Innovation?

From my own understanding and experience, too many regulations or rules in quality control testing can definitely slow down progress. In my previous e...

1 month ago
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RE: Are Regulations Helping Innovation or Slowing It Down?

I think that regulations are extremely important for public transparency and risk reduction. They set a baseline of what needs to be done at minimum t...

2 months ago
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RE: Does the FDA guarantee safety?

I think the biggest aspect of the safe vs unsafe aspects of any medical device or product depends on the testing done, the science behind it, the publ...

2 months ago
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RE: FDA Classes: Reform needed or fine as is?

I think this is a great question, especially since there are new technologies being made that might not be able to be classified as easily. I do belie...

2 months ago
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RE: What Is the Biggest Challenge in Pre-clinical Device Development?

I would definitely say from a researcher's perspective, navigating the organizational and approval process is the more challenging part of pre-clinica...

2 months ago
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RE: Animal Diversity in Pre-clinical Research

From what I have learned and from the experiences I have heard from other people, animal variety can have significant effects on reproducibility, on b...

2 months ago
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RE: When researching, are you Academia or Industry?

I would definitely prefer industry when it comes to research for medical device development. The first reason is because of the availability of direct...

2 months ago
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RE: Milestones Missed: Failure or Success?

In my opinion, missing a milestone is not directly a failure, although it does sound like one. For example, companies miss milestones all the time, bu...

2 months ago
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RE: Which feature is the most important for a project manager?

In my opinion, a project manager needs to have 1 main quality: openness. The manager needs to be open to ideas, open to the team, open to change, etc....

2 months ago
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RE: Managing Team Opinions While Sticking to Decisions

I can agree with a lot of the points that have been made before my post, specifically on the communication aspect and the openness with the team. In m...

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

I think this is a great question that applies to basically everyone. I have though about this question often, since I have done both research and have...

2 months ago
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RE: Medical Device News

@pz98 @vanshamin I think you guys brought up some great points about the use of AI in the medical device industry. I have read many articles and learn...

2 months ago
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RE: Thoughts on BME degree, "a little of everything"

I do agree that a BME degree has disadvantages and advantages, but more on the advantages side. I have heard from multiple people that BME is too spec...

2 months ago
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