Qa And Regulatory Manager
India
Complaince with ISO9001, ISO13485, ISO14001Complaince with CE mark, IS 13422, IS4148 and USFDABrand included done in CE Mark ( Class: IIa)Technical file updated as per MDD 93/42/EECProcedure updated as per current practice.Gloves release done as per ASTM 3577, ISO 10282, EN 455 - 1,2,3,4, IS 13422, IS 4148,Sterilizer validation done as per ISO 11135Package validation done as per ISO 11607IS Marking fee calculation and renewal doneCentrifuge in latex monitorShelf life study of gloves carried outRegistration dossier prepared for Australia,Ukraine,Tanzania and EthiopiaRisk Management File updatedPMS,PMCF done as per MDD requirementsCAPA verification done as per USFDA requirements.New material approval process doneISO 13485,9001,14001certification and IS certification get for New sister concern.