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Josh
@orleron
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Joined: Mar 14, 2015
Last seen: Apr 2, 2025
Topics: 59 / Replies: 36
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RE: Discussion Topic: Biomedical Engineering vs. Bioengineering

Well said, JOnyekwere. Bioengineering deals a lot with the cultivation of biological products, such as those used in the pharmaceutical/biologics indu...

6 years ago
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RE: Discussion Topic: Course conclusion and impressions

Class, Thanks for the great 2018 comments. I do take all your words into consideration. This is an interesting time in medical devices, as you will ...

6 years ago
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RE: Discussion Topic: Supplemental on DHF and DMR

Interestingly, as a brand new development which I have not had time to update for the course, Design Controls are now in fact required virtually every...

6 years ago
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RE: Thoughts and Questions Related to Untested Medicine

test Spiral Medical Development test post

7 years ago
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RE: Discussion Topic: Practical vs. Informational courses

Is a student 100% equipped to know what he or she should focus on during the course of study?

7 years ago
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RE: Discussion Topic: Academia vs. Industry

Regarding budget cuts, keep in mind that although we do not get our funding almost exclusively from grants when we work in industry, we do have budget...

7 years ago
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RE: CE TECH File Vs 510(k) submission differences

Remember as we discussed in Medical Device Development, even if something goes through the 510K process in the US, it still undergoes design controls ...

7 years ago
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RE: Classification in FDA Vs EU

Yes, good catch on the joint implants. They are a higher class in the EU than the US. The impression in general is that EU classifications are someh...

7 years ago
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RE: Design Controls in the other countries

The idea, in general, is that there are two basic kinds of regulatory systems: A) Systems that document the current snapshot of the device's design/m...

7 years ago
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RE: CRO or Big Pharma

Keep in mind that pharma trials are very different from device trials, i.e. Phase I, II, II vs. no phases. The larger CRO's can do both types, but th...

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

Keep in mind here that Participation always involves a two-way communication, over whatever media. Product placement, exclusive content, etc. and ads...

7 years ago
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