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SUMMARY:ASQ: Program Meeting - First Pass Design Controls
DESCRIPTION:First Pass Design Controls –\nGetting it Right on your First Medical Device\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nIf you’re part of a new startup or an insulated development team in a larger company\, you probably know how daunting it can be to collect the evidence required to demonstrate to a regulatory body that design requirements have been met. \nFDA regulations require design controls to help ensure this\, which can translate into many hours of reviews\, oversized spreadsheets\, and enough signatures to slow a change assessment system to a crawl. \nBut when implemented correctly\, design controls enhance – rather than hinder – development efforts while providing the assurance needed to enter the submission process with confidence. \nThis presentation takes a practical look at design controls within FDA regulations and how they’ve been implemented across the medical device industry. And you’ll earn 0.2 RU’s (Recertification Units)! \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\nClick Here for more info or to register!
URL:https://www.mfests.org/event/asq-program-meeting-first-pass-design-controls/
LOCATION:Webinar
CATEGORIES:ASQ
ORGANIZER;CN="ASQ-MN%20Section":MAILTO:info@mnasq.org
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