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es446
@es446
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Joined: Jan 20, 2020
Last seen: Dec 4, 2022
Topics: 1 / Replies: 76
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RE: What role would best fit your experience/skillset in clinical research?

Since I’m currently working as a manufacturing engineer in the medical device industry, I can see myself fitting best in the Sponsor role when it come...

2 years ago
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RE: FDA GCP's

When learning about Good Clinical Practices (GCP) in this week’s lecture, I was reminded of a concept that I use daily as an engineer working in indus...

2 years ago
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RE: Placebo's Impact on Pain-related Clinical Research

I don’t think it’s possible to eliminate the placebo effect, especially in studies that rely on patient-reported data such as pain level. But as jdfos...

2 years ago
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RE: Importance of building TRUST as a Sales Rep

Establishing a successful business relationship with the customer is especially valuable in the medical device industry because for many devices, the ...

2 years ago
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RE: Discussion Topic: The Fifth "P" of Marketing

Several years ago I encountered an interesting example of participation-focused marketing when I was walking around the mall. The Korean skincare bran...

2 years ago
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RE: Advertising

I think a lot of what makes an advertisement memorable is repetition. If people are exposed to a certain jingle or slogan over and over again, it's in...

2 years ago
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RE: Medical device startup: Partnership vs LLC vs S-Corp

@sm2744 I could see an S-Corp organization being difficult for biotech/med device organizations simply because S-Corps are more limited in scope than ...

2 years ago
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RE: C-Corp

A C-Corp would be better to have over an S-Corp for many of the reasons stated above; S-Corps are in general a lot more restricted in their growth and...

2 years ago
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RE: LLP’s responsibility

The typical LLP is owned by a few professionally licensed partners who benefit from the fact that each partner is not liable for any legal action take...

2 years ago
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RE: Examples and ways to improve quality assurance

To further add on to what @mayasaunders mentioned, cleanliness in the production area is especially important when manufacturing sterile devices that ...

2 years ago
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RE: Job Skills in Quality - Root Cause Analysis

In my job, I've seen Root Cause Analysis used most often when dealing with CAPAs. CAPA stands for Corrective and Preventive Action, and put simply is ...

2 years ago
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RE: Auditing Bodies

I think MDSAP is a great way to standardize the auditing process and prepare companies to sell their devices to a wider, worldwide market. Currently 5...

2 years ago
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RE: FDA on Recalled Items

A recent, infamous example of a recall is Abbott's recall of their baby formula products which occurred February 17th, 2022. The recall was initiated ...

2 years ago
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RE: 510K is Nonsense

This topic brings up an interesting point - even though filing a 510(k) is easier than going the PMA route, and can greatly expedite getting new scien...

2 years ago
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RE: Species in Animal Testing

I do think it's interesting to discuss using other, less conventional animal species in pre-clinical trials, especially because it could help with sup...

2 years ago
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