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Luxacrown Case Study

Satisfactory Essays

LuxaCrown (US) On 9/1 Sonja email Rob, the initial documentation to commence LuxaCrown dossier, (e.g. preliminary IFU, Labels, Risk Analysis, Declaration of Conformity, Clinical Evaluation, Product specifications, SDS, Flyer and Quality control report along with supporting documents STED) On 9/1 Rob email Sonja, requesting further information as well as the contact name, title and email for the DMG contact associated with the manufacturer (See attached Rob’s full email request) On 9/14 Sonja email Rob, letting him know that they won’t have the requested documents available for about 6 weeks (see attached Sonja’s full email) Ecosite Bulk Fill (US) On 9/28 Deborah email Elizabeth (me), that additional testing has been initiated at DMG and

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