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Natalie Nashed
@natalie-nashed
Eminent Member
Joined: Sep 2, 2025
Last seen: Nov 4, 2025
Topics: 0 / Replies: 27
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RE: Initializing Design Controls

If I were a manager updating design controls, I'd start by improving communication and training before changing any documents or systems. Too often, p...

6 days ago
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RE: The Relationship Between Verification and Validation

I think verification and validation can sometimes happen at the same time, especially during prototype testing or early design iterations, but they sh...

6 days ago
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RE: Impact of customer feedback on design inputs

I agree that vague feedback can be hard to use, but I think teams can still learn a lot by watching how customers actually interact with a product ins...

6 days ago
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RE: Handling Adverse Events in Trials

I think having a standardized process for handling adverse events is essential, but it should also include build-in flexibility. Each trial is differe...

2 weeks ago
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RE: Clinical Research Experience/Course work for Biomedical Engineers

I really agree with what a lot of people here have said about the gap between classroom learning and real-world clinical experience. I think spending ...

2 weeks ago
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RE: Placebo Effect

I think another interesting angle that hasn't been mentioned yet is how the placebo effect can actually reveal the power of patient-clinician interact...

2 weeks ago
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RE: The Four P's

To agree with many others, I think the product is overall the most essential part of the four P's. You can have the best promotion, price, and placeme...

3 weeks ago
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RE: Transition from Engineering to sales or marketing?

If I were to transition out of engineering, I'd probably lean toward marketing, especially since I'm pursuing a business minor. I think marketing woul...

3 weeks ago
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RE: Importance of building TRUST as a Sales Rep

I totally agree that the building trust is the biggest part of being a successful sales rep in the medical device industry. These relationships can la...

3 weeks ago
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RE: Public vs. Private

Going private can be a good thing for a company like EA that you mentioned because it gives them more freedom to focus on their long-term goals rather...

4 weeks ago
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RE: LLP vs LLC

I think most people choose an LLC over an LLP because of how much simpler and more flexible it is to manage. My brother actually started his own LLC c...

4 weeks ago
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RE: 80% margin

I was also shocked when the Professor dropped this fact in the lecture video, 80% seemed really high to me for a medical device. I was talking to a cl...

4 weeks ago
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RE: Common challenges faced while auditing a Quality Management System (QMS) in the medical device industry & how can they be dealt with

From what I've read, one of the most common issues during QMS audits is weak traceability, especially when companies can't clearly connect design chan...

1 month ago
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RE: Most effective ways to manage risk in the context of Quality Assurance for high-risk medical devices (Class III)

Quality assurance can also make sure Class III devices meet safety standards by focusing on strong documentation and traceability during design and de...

1 month ago
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RE: Regulatory Compliance and Quality Assurance

I think the biggest challenge right now is keeping quality control up to speed with how quickly medical device technology is advancing. Devices aren't...

1 month ago
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