ISO 13485 Toolkits Pricing & Options
-
For implementation of parts of the standardFor implementing a full standard
ISO 13485
Internal Audit ToolkitISO 13485
Documentation ToolkitEU MDR & ISO 13485
Integrated Documentation ToolkitPriceUS $197US $897997 EURNumber of documentsEditable MS Word and MS Excel policies, procedures, plans and forms that you can adapt to your company needs.5 documents75 documents101 documentsAll documents required by ISO 13485Extended set of internal audit documentsCommonly used non-mandatory procedures and formsFully compliant withISO 13485:2016ISO 13485:2016ISO 13485:2016, ISO 14971:2019, EU MDR 2017/745MDR documents including Clinical Evaluation, Post-Market Surveillance and Technical mapsISO 14971 risk management documents including Procedure for FMEA Risk AssessmentDocuments for sterilization process: Procedure for EtO Sterilization; Procedure for Dry Heat Sterilization; Procedure for Ionizing Radiation Sterilization; Procedure for Filtration SterilizationFor implementation of parts of the standard
ISO 13485 Internal Audit Toolkit
Price$197US $197Number of documentsEditable MS Word and MS Excel policies, procedures, plans and forms that you can adapt to your company needs.5 documentsExtended set of internal audit documentsFully compliant withISO 13485:2016Available product languagesFor implementing a full standard
ISO 13485 Documentation Toolkit
Price$897US $897Number of documentsEditable MS Word and MS Excel policies, procedures, plans and forms that you can adapt to your company needs.75 documentsAll documents required by ISO 13485Extended set of internal audit documentsCommonly used non-mandatory procedures and formsFully compliant withISO 13485:2016Available product languagesEU MDR & ISO 13485 Integrated Documentation Toolkit
Price997997 EURNumber of documentsEditable MS Word and MS Excel policies, procedures, plans and forms that you can adapt to your company needs.101 documentsAll documents required by ISO 13485Extended set of internal audit documentsCommonly used non-mandatory procedures and formsFully compliant withISO 13485:2016, ISO 14971:2019, EU MDR 2017/745MDR documents including Clinical Evaluation, Post-Market Surveillance and Technical mapsISO 14971 risk management documents including Procedure for FMEA Risk AssessmentDocuments for sterilization process: Procedure for EtO Sterilization; Procedure for Dry Heat Sterilization; Procedure for Ionizing Radiation Sterilization; Procedure for Filtration SterilizationAvailable product languages -
ISO 13485 & MDR
Integrated Documentation ToolkitConsultant
White Label ToolkitPrice997 EURDocumentation can be usedfor your own company onlyfor your own company + for 10 of your clientsNumber of documents101 documents101 documentsAll required ISO 13485:2016, ISO 14971:2019 and EU MDR documentsWhite label templatesGet all our documentation templates without the Advisera copyright – your clients will never know you got them from us.Division of tasks & time planA plan that suggests which tasks should be done by a consultant and which by a client, with suggested timing for each.Sales presentationPresentation that will help you present your consulting services to potential customers.Consulting proposalA template that can be used to send a detailed proposal of your services to the potential client.Stakeholder mappingA table where all the stakeholders in the project are listed, together with the most appropriate actions for each of them in order to reduce the project risk.ISO 13485 & MDR Integrated Documentation Toolkit
Price997997 EURDocumentation can be usedfor your own company onlyNumber of documents101 documentsAll required ISO 13485:2016, ISO 14971:2019 and EU MDR documentsConsultant White Label Toolkit
PriceDocumentation can be usedfor your own company + for 10 of your clientsNumber of documents101 documentsAll required ISO 13485:2016, ISO 14971:2019 and EU MDR documentsWhite label templatesGet all our documentation templates without the Advisera copyright – your clients will never know you got them from us.Division of tasks & time planA plan that suggests which tasks should be done by a consultant and which by a client, with suggested timing for each.Sales presentationPresentation that will help you present your consulting services to potential customers.Consulting proposalA template that can be used to send a detailed proposal of your services to the potential client.Stakeholder mappingA table where all the stakeholders in the project are listed, together with the most appropriate actions for each of them in order to reduce the project risk.
Still not sure which toolkit is the best option?
Contact us now. We respond quickly.
Schedule a Call
Please enter your details below.