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 Bindt Form 57b 2014

2014-2025 Form

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Instructions and help about Bindt Form 57b

I represent Who I am my name is Thor Rollins I work at nelson Laboratories I've worked at Nelson about 15 years Nelson is a CRO does clinical testing for our medical devices and my I've been 15 years working in biocompatibility so that's kind of what my love is I sit on the TCC 194 working group which is the ISO group that writes the standards for biocompatibility and in fact before I start there's been well for me exciting news you guys probably don't care as much but in 2013 the FDA released a guidance document for biocompatibility it was a draft today actually the last 20 minutes they just released their final document I wish we could just sit here and go through that together because I haven't read it it's like 260 pages long so I haven't sat down and gone through it yet but that's not why we're here and so we're gonna be talking about changes to a device and how to evaluate it with my own compa

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