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you hello ladies and gentlemen and welcome to global compliance panels live webinar on the 510 K submission requirements contents and options my name is michael and iamp;#39;ll be a host for todayamp;#39;s session and on behalf of the global compliance panel team iamp;#39;d like to thank you all for being part of todayamp;#39;s session todayamp;#39;s webinar is being presented by mr. jeff kassov few words about a jeff before we start off todayamp;#39;s session mr. Kosloff RAC cqm is also the director of quality at meditators which is a leading manufacturer of endoscopy and colonoscopy devices where he oversees the operation of the quality system and in this position Jeff is responsible for oversight of the document control system and also is the primary liaison with the regulatory affairs officials and also prior to this Jeffamp;#39;s mentor with 13 years at lifecycle cooperated as the director of regulatory affairs where he was responsible for compliance of the corporate qualit
