Fundamentals of Medical Device Regulations, Fifth Edition

Books Member: $295.00 | Nonmember: $395.00 510(k)AdvancedBreakthrough devices programCDRHCE MarkDe novoDiagnostics/IVDsDigital health/SaMD/AIEuropean CommissionExpertFoundationalGlobalGuidanceIMDRFIn Vitro Diagnostic Medical Devices Regulation (IVDR)IntermediateISO 13485Laboratory developed tests (LDTs)Medical device reportingMedical DevicesMedical Devices Regulation (MDR)Notified BodiesProduct developmentResearch, Design and Development