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alexandrabuga
@alexandrabuga
Estimable Member
Joined: Sep 8, 2017
Topics: 9 / Replies: 140
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RE: Discussion Topic: Mission and Vision statements

Medtronic It's important to have a vision and mission statement to provide direction, it is the foundation of a company. Vision is a general broad s...

7 years ago
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RE: Public vs. Private Companies

As many have stated, the main difference between a private and public companies, is that public companies have stocks that are traded publicly and the...

7 years ago
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RE: Types of Corporations

If I had my own device/biotech company, I would do the paperwork to set up a corporation-C corp. The advantages of setting up a corporation were discu...

7 years ago
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RE: Corporate Veil

Reading this question I thought instantly of Martin Shkreli the 34-year-old chief executive of Turing Pharmaceuticals, who had raised the price of the...

7 years ago
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RE: Discussion Topic: Inc. vs. LLC in the US

I agree with @bb224 and @asimbana that for a medical device company of mid-size with 50 people and $10 million in revenue they should be an Inc so the...

7 years ago
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RE: Discussion Topic: Exercise your research skills

I did some research on Amgen Inc. Amgen is up 6.84% in sales with 5.8B in revenues with Net Income of $2.2B. Quarter Financials as of June 2017 Gro...

7 years ago
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RE: What are some ways Document Control can improve?

This is a little out of my scope of my job, but I was just at conference and the large device companies use different systems. For example Cognition h...

7 years ago
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RE: Experience in Quality Assurance and Quality Control

I interned one summer at Pfizer in their Analytical Science and Technology lab for 10 -weeks researching the prediction of product quality attributes ...

7 years ago
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RE: Your Ideas about Improving Quality Control

I do not work in industry, but I'm currently at the 2017 American Medical Device Summit in Chicago. I spoke with Liz Iversen who is the SVP, Chief Qua...

7 years ago
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RE: Discussion Topic: The cost of Quality

I echo the sentiments of others like @asimbana and @bb254 that QA/QC is necessary and is crucial to the success of products. Spending extra time and m...

7 years ago
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RE: Changes in FDA under Trump's Administration

Yes, if this goes through Congress the increase in medical device user fees would affect small/midsize companies. However as the FierceHealthcare arti...

7 years ago
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RE: Discussion Topic: The de Novo 510(k) Process

@Srg36 did a great job of summarizing the de Novo classification process and ruling. I agree that this deNovo classification process is beneficial bec...

7 years ago
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RE: Discussion Topic: Antibiotic-Releasing Hip Stem

For an antibiotic-releasing hip-stem Device Type: combination device The primary mode of action: Hip-stem, structural replacing a bone- holding up a ...

7 years ago
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RE: Discussion Topic: e-cigarettes

As @thuytienlaco and @amandaally1029 stated, e-cigarettes are regulated by the FDA. In Aug 2016 the FDA finalized the rule extending CTP's regulatory ...

7 years ago
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RE: Approaches to Research

I agree with many like @gaberuiz13 and @su65 that academic research is for the passion and thrill of discovery and answering questions for unknowns in...

7 years ago
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