Global Medical Device Regulatory Strategy, Second Edition

Books Member: $205.00 Nonmember: $285.00 510(k)AdvancedAdvertising, Promotion and LabelingApproval/marketing authorizationBreakthrough devices programCDRHCE MarkCombination productsComplianceCybersecurityDiagnostics/IVDsDigital health/SaMD/AIExpedited pathwaysExpertFoundationalGlobalHealth Authority meeting and communication strategyIMDRFIn Vitro Diagnostic Medical Devices Regulation (IVDR)IntermediateMedical DevicesMedical Devices Regulation (MDR)Preclinical studyProduct LifecycleQuality management system/QMSRegulatory strategyRisk managementSubmission and registration