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INSTRUCTION MANUAL Dosing System MID MDS DOC Bopp Reuther  Form

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all right well thanks for inviting me uh so like she said my name is donnie musgrove i'm a statistician at medtronic um a little background i've been a statistician in research and development in medtronic for five years we focus on my group on implantable cardiac devices um and i realize as i've sat through this for a day and a half that there's not a lot about devices and so our regulatory is um our processes are quite a bit different than pharma right you got phase one two three we don't actually have that in um our devices so hopefully this can translate um and you can find some use from this um so just a little background on the package so i'm going to be talking about the package the development process and its ultimate use in a clinical trial so i'm going to focus just a little bit on the actual utility of the package so the base dp package dp setting for discount prior has several functions for combining historical or exte

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