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Introduction/Question about medical devices

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jota

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I found out about this forum. I want to know how to start a medical device company.

I just graduated from college and I have a lot of friends that are engineering majors. Some of my friends spent a lot of time designing a medical device. They are already in the process of patenting it through my school, so the school covers the cost of patenting the idea. After talking to them, they were explaining to me why their design is better than what is currently on the market. However, none of them have the time to try and market and sell it.

From what I've read getting FDA approval won't be that difficult because there is already something similar on the market (the 510c law).

I already found a company that I can use to get a prototype made as well. A side from the actual incorporating part (I also set up a meeting with my school's small business development center) what else would I need to do? It wouldn't make much sense for me to license the product from my friends and then license it to another company.
 
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Fu zua qmep up nepagedvasoph vji qsufadv?

Vjisi ot e muv vu duptofis fiqipfoph up zuas fiwodi. Og ov ot e dmett 1 ov xomm ci e muv mitt xusl. Cav cideati zua nipvoup e 510l, ov ot qsucecmz e dmett 2 us 3 fiwodi?

O xuamf tez vji gostv tviq xuamf vu ci vu dupvedv e sihamevusz duptamvepv xju tqidoemobit op nifodem fiwodit.

Katv e gix vjopht vu vjopl ecuav cigusi zua iwip timm ot jux vji fitohp xet jepfmif. Fuit ov niiv OID 60601 siraosinipvt? Jet vji fitohp ciip qsuqismz fudanipvif (fitohp jotvusoit epf vitvoph)?

Et zua tvesv vu timm epf/us nepagedvasi zua xomm piif e raemovz tztvin op qmedi. Vjot emupi ot e muv ug xusl. Ov xomm emtu jewi vu gedi vji vitv ug vji GFE.
 
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