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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 i'll be a host for today's session and on behalf of the global compliance panel team i'd like to thank you all for being part of today's session today's webinar is being presented by mr. jeff kassov few words about a jeff before we start off today'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 Jeff's mentor with 13 years at lifecycle cooperated as the director of regulatory affairs where he was responsible for compliance of the corporate quality system and Jeff's received his regulatory affairs cert

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