ISO 13485 Toolkits Pricing & Options
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For implementation
of parts of the standardOnly for companies
that already have a QMSFor implementing
a full standardISO 13485
Internal Audit ToolkitEU MDR Documentation Toolkit
ISO 13485
Documentation ToolkitISO 13485 & MDR
Integrated Documentation ToolkitPriceUS $197597 EURUS $8971097 EURNumber of documentsEditable MS Word and MS Excel policies, procedures, plans, and forms that you can adapt to your company needs.5 documents31 documents82 documents117 documentsAll documents required by ISO 13485Extended set of internal audit documentsCommonly used non-mandatory procedures and formsFully compliant withISO 13485:2016EU MDR 2017/745ISO 13485:2016ISO 13485:2016
ISO 14971:2019
EU MDR 2017/745ISO 14971 risk management documentsMDR documents including Regulatory Compliance, Clinical Evaluation, Post-Market Surveillance and Technical MapsDocuments 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 standardISO 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 languagesOnly for companies
that already have a QMSEU MDR Documentation Toolkit
Price597597 EURNumber of documentsEditable MS Word and MS Excel policies, procedures, plans, and forms that you can adapt to your company needs.31 documentsCommonly used non-mandatory procedures and formsFully compliant withEU MDR 2017/745MDR documents including Regulatory Compliance, Clinical Evaluation, Post-Market Surveillance and Technical MapsAvailable product languagesFor implementing
a full standardISO 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.82 documentsAll documents required by ISO 13485Extended set of internal audit documentsCommonly used non-mandatory procedures and formsFully compliant withISO 13485:2016ISO 14971 risk management documentsAvailable product languagesISO 13485 & MDR Integrated Documentation Toolkit
Price10971097 EURNumber of documentsEditable MS Word and MS Excel policies, procedures, plans, and forms that you can adapt to your company needs.117 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 2017/745ISO 14971 risk management documentsMDR documents including Regulatory Compliance, Clinical Evaluation, Post-Market Surveillance and Technical MapsDocuments 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 ToolkitPrice1097 EURDocumentation can be usedfor your own company onlyfor your own company + for 10 of your clientsNumber of documents117 documents117 documentsAll required ISO 13485:2016, ISO 14971:2019 and EU MDR documentsWhite label templatesGet all our documentation templates without the 13485Academy 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
Price10971097 EURDocumentation can be usedfor your own company onlyNumber of documents117 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 documents117 documentsAll required ISO 13485:2016, ISO 14971:2019 and EU MDR documentsWhite label templatesGet all our documentation templates without the 13485Academy 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.
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