ISO 13485 / CFR 820 Cost Calculator [Certification Fee not Included] Please enable JavaScript in your browser to complete this form. - Step 1 of 213485 + CFR 820 FEE CALCULATOR STANDARD INTRESTEDISO 1348521 CFR 820ISO 13485+IEC 62304ISO 13485+21 CFR 820ISO 13485+21 CFR 820+IEC 6230421 CFR 820 + IEC 62304ACTIVITIES (MY LOCATION)DesigningManufacturingQuality ControlSterilizationDistributionInstallation & ServicingSoftware DevelopmentACTIVITIES (OUTSOURCED LOCATION)DesigningManufacturingQuality ControlSterilizationTransportationSoftware DevelopmentSoftware TestingSTEP 1 [DRAFTING OF DOCUMENTS]Quality Manual,Mandatory Procedures,Record TemplatesGMDN Code per device is mandatoryMANPOWER<10<20<30Total manpower including top management.STEP 2 [ PROCESS OWNER(S) GUIDANCE]4 days Online2 days Online & 2 days Onsite6 days Online & 2 days Onsite8 days Online & 2 days OnsiteSTEP 3 [ IMPLEMENTATION SUPPORT]4 days Online8 days (Online)6 days Online & 2 days Onsite8 days Online & 2 days OnsiteSTEP 4 [ INTERNAL AUDIT]Not Interested2 days (Online)2 days (Onsite)STEP 5 [ CERTIFICATION AUDIT]No Support required2 days (Online)2 days (Onsite)Support during Certification Body AuditSTEP 2 [ PROCESS OWNER(S) GUIDANCE]5 days (Online)6 days Online & 2 days Onsite8 days Online & 2 days Onsite10 days Online & 2 days Onsite12 days Online & 2 days OnsiteSTEP 3 [ IMPLEMENTATION SUPPORT]6 days Online10 days Online8 days Online & 2 days Onsite10 days Online & 2 days Onsite12 days Online & 2 days OnsiteSTEP 4 [ INTERNAL AUDIT]Not Interested2 days (Online)2 days (Onsite)STEP 5 [ CERTIFICATION AUDIT]No Support required2 days (Online)2 days (Onsite)Support during Certification Body AuditSTEP 2 [ PROCESS OWNER(S) GUIDANCE]6 days (Online)6 days Online & 2 days Onsite8 days Online & 2 days Onsite10 days Online & 2 days Onsite12 days Online & 2 days Onsite14 days Online & 2 days OnsiteSTEP 3 [ IMPLEMENTATION SUPPORT]8 days Online10 days Online10 days Online & 2 days Onsite12 days Online & 2 days Onsite14 days Online & 2 days OnsiteSTEP 4 [ INTERNAL AUDIT]Not Interested3 days (Online)2 days (Onsite)3 days (Onsite)STEP 5 [ CERTIFICATION AUDIT]No Support required2 days (Online)2 days (Onsite)Total Summary Name Total (โฌ) STANDARD INTERESTED ISO 13485 21 CFR 820 ISO 13485+IEC 62304 ISO 13485+21 CFR 820 ISO 13485+21 CFR 820+IEC 62304 21 CFR 820 + IEC 62304 ISO 1348521 CFR 820ISO 13485+IEC 62304ISO 13485+21 CFR 820ISO 13485+21 CFR 820+IEC 6230421 CFR 820 + IEC 62304ACTIVITIES (MY LOCATION) Designing Manufacturing Quality Control Sterilization Distribution Installation & Servicing Software Development DesigningManufacturingQuality ControlSterilizationDistributionInstallation & ServicingSoftware DevelopmentACTIVITIES (OUTSOURCED LOCATION) Designing Manufacturing Quality Control Sterilization Transportation Software Development Software Testing DesigningManufacturingQuality ControlSterilizationTransportationSoftware DevelopmentSoftware TestingSTEP 1 [DRAFTING OF DOCUMENTS] Quality Manual Quality ManualMandatory Procedures Mandatory ProceduresRecord Templates Record TemplatesSTEP 2 [ PROCESS OWNER(S) GUIDANCE] 4 days Online 2 days Online & 2 days Onsite 6 days Online & 2 days Onsite 8 days Online & 2 days Onsite 4 days Online2 days Online & 2 days Onsite6 days Online & 2 days Onsite8 days Online & 2 days OnsiteSTEP 3 [ IMPLEMENTATION SUPPORT] 4 days (Online) 8 days (Online) 6 days Online & 2 days Onsite 8 days Online & 2 days Onsite 4 days (Online) 8 days (Online) 6 days Online & 2 days Onsite8 days Online & 2 days OnsiteSTEP 4 [ INTERNAL AUDIT] Not Interested 2 days (Online) 2 days (Onsite) Not Interested2 days (Online)2 days (Onsite)STEP 5 [ CERTIFICATION AUDIT] No Support required 2 days (Online) 2 days (Onsite) No Support required 2 days (Online) 2 days (Onsite)STEP 2 [ PROCESS OWNER(S) GUIDANCE] 5 days (Online) 6 days Online & 2 days Onsite 8 days Online & 2 days Onsite 10 days Online & 2 days Onsite 12 days Online & 2 days Onsite 5 days (Online) 6 days Online & 2 days Onsite8 days Online & 2 days Onsite10 days Online & 2 days Onsite12 days Online & 2 days OnsiteSTEP 3 [ IMPLEMENTATION SUPPORT] 6 days Online 10 days Online 8 days Online & 2 days Onsite 10 days Online & 2 days Onsite 12 days Online & 2 days Onsite 6 days Online10 days Online 8 days Online & 2 days Onsite10 days Online & 2 days Onsite12 days Online & 2 days OnsiteSTEP 4 [ INTERNAL AUDIT] Not Interested 2 days (Online) 2 days (Onsite) Not Interested2 days (Online)2 days (Onsite)STEP 5 [ CERTIFICATION AUDIT] No Support required 2 days (Online) 2 days (Onsite) No Support required 2 days (Online) 2 days (Onsite) STEP 2 [ PROCESS OWNER(S) GUIDANCE] 6 days (Online) 6 days Online & 2 days Onsite 8 days Online & 2 days Onsite 10 days Online & 2 days Onsite 12 days Online & 2 days Onsite 14 days Online & 2 days Onsite 6 days (Online) 6 days Online & 2 days Onsite8 days Online & 2 days Onsite10 days Online & 2 days Onsite12 days Online & 2 days Onsite14 days Online & 2 days OnsiteSTEP 3 [ IMPLEMENTATION SUPPORT] 8 days Online 10 days Online 10 days Online & 2 days Onsite 12 days Online & 2 days Onsite 14 days Online & 2 days Onsite 8 days Online 10 days Online 10 days Online & 2 days Onsite12 days Online & 2 days Onsite14 days Online & 2 days OnsiteSTEP 4 [ INTERNAL AUDIT] Not Interested 3 days (Online) 2 days (Onsite) 3 days (Onsite) Not Interested3 days (Online)2 days (Onsite)3 days (Onsite)STEP 5 [ CERTIFICATION AUDIT] No Support required 2 days (Online) 2 days (Onsite) No Support required 2 days (Online) 2 days (Onsite) Total (โฌ) TotalNextName *Email *Phone *PreviousSend Email ISO 13485 CERTIFICATIONREQUEST PROPOSAL (ISO 13485)REQUEST PROPOSAL (21 CFR 820)ISO 13485 / CFR 820 PRICING