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UID:2069@azbio.org
DTSTART;TZID=America/Phoenix:20260908T160000
DTEND;TZID=America/Phoenix:20260908T170000
DTSTAMP:20260901T172552Z
URL:https://www.azbio.org/events/build-your-fda-strategy-from-day-one
SUMMARY:Build Your FDA Strategy From Day One -  - 8 Sep 26 16:00
DESCRIPTION:\n\n\nTuesday\, September 8th\, 4:00 - 5:00 pm\n\n\n\n\n\n\n\n\
 n\n\n\n\n\n\n\n\n\n\n\n\n\n\nBuild Your FDA Strategy From Day One\n\n\nFor
  medical device and IVD companies\, your FDA strategy shouldn’t be an af
 terthought. The decisions you make early can shape your development timeli
 ne\, commercialization strategy\, and path to market.\n\nJoin CEI and Nuc
 leate on Tuesday\, September 8\, for FDA Roadmap: Building Your Regulato
 ry Strategy from Day One\, a practical session designed to help founders a
 nd innovators approach the regulatory process with greater clarity and con
 fidence.\n\nYou’ll learn how to identify the right regulatory pathway fo
 r your product\, prepare for FDA interactions\, integrate regulatory requi
 rements into product development\, and avoid common pitfalls that can slow
  your progress.\n\nFrom 510(k)\, De Novo\, and PMA pathways to FDA meeti
 ngs\, compliance\, DHFs\, and LDT considerations\, this session will help 
 you start building a regulatory strategy that supports\, not slows\, comme
 rcialization.\n\nTuesday\, September 8\nCenter for Entrepreneurial Innovat
 ion (CEI)\n275 Gateway Drive\, Phoenix\, AZ\nHybrid | In-person attendance
  encouraged\n\n\n\n\n\n\n\n\n\n\n\n\n\nIf you're developing a medical devi
 ce or diagnostic\, this is a conversation worth having early.\n\n\n\n\n\n\
 n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nTuesday\, September 8th\, 4
 :00 - 5:00 pm\n\n\n\n\n\n\n\n\n\n\n\n\n\nSave my seat\n\n\n\n\n\n\n\n\n\n\
 n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nSpeaker Inf
 o\n\n\n\n\n\nKristen Mittal\n\n\nCo-founder &amp\; CEO\, Mittal Consulting
 \n\n\nKristen Mittal\, RAC\, PMP\, is Co-founder and CEO of Mittal Consult
 ing\, helping medical device companies navigate regulatory and reimburseme
 nt pathways. With more than a decade of regulatory experience\, she helps 
 innovators move complex medical technologies to market.\n\n\n\n\n\n\n\n\n\
 n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\
 n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
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