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ISO 13485 Toolkits Pricing & Options

  1. For implementation
    of parts of the standard
    Only for companies
    that already have a QMS
    For implementing
    a full standard

    ISO 13485
    Internal Audit Toolkit

    EU MDR Documentation Toolkit

    ISO 13485
    Documentation Toolkit

    ISO 13485 & MDR
    Integrated Documentation Toolkit

    Number of documents
    Editable MS Word and MS Excel policies, procedures, plans, and forms that you can adapt to your company needs.
    5 documents
    31 documents
    82 documents
    117 documents
    All documents required by ISO 13485
    Extended set of internal audit documents
    Commonly used non-mandatory procedures and forms
    Fully compliant with
    ISO 13485:2016
    EU MDR 2017/745
    ISO 13485:2016
    ISO 13485:2016
    ISO 14971:2019
    EU MDR 2017/745
    ISO 14971 risk management documents
    MDR documents including Regulatory Compliance, Clinical Evaluation, Post-Market Surveillance and Technical Maps
    Available product languages

    For implementation
    of parts of the standard

    ISO 13485 Internal Audit Toolkit
    Number of documents
    Editable MS Word and MS Excel policies, procedures, plans, and forms that you can adapt to your company needs.
    5 documents
    Extended set of internal audit documents
    Fully compliant with
    ISO 13485:2016
    Available product languages

    Only for companies
    that already have a QMS

    EU MDR Documentation Toolkit
    Number of documents
    Editable MS Word and MS Excel policies, procedures, plans, and forms that you can adapt to your company needs.
    31 documents
    Commonly used non-mandatory procedures and forms
    Fully compliant with
    EU MDR 2017/745
    MDR documents including Regulatory Compliance, Clinical Evaluation, Post-Market Surveillance and Technical Maps
    Available product languages

    For implementing
    a full standard

    ISO 13485 Documentation Toolkit
    Number of documents
    Editable MS Word and MS Excel policies, procedures, plans, and forms that you can adapt to your company needs.
    82 documents
    All documents required by ISO 13485
    Extended set of internal audit documents
    Commonly used non-mandatory procedures and forms
    Fully compliant with
    ISO 13485:2016
    ISO 14971 risk management documents
    Available product languages
    ISO 13485 & MDR Integrated Documentation Toolkit
    Number of documents
    Editable MS Word and MS Excel policies, procedures, plans, and forms that you can adapt to your company needs.
    117 documents
    All documents required by ISO 13485
    Extended set of internal audit documents
    Commonly used non-mandatory procedures and forms
    Fully compliant with
    ISO 13485:2016
    ISO 14971:2019
    EU MDR 2017/745
    ISO 14971 risk management documents
    MDR documents including Regulatory Compliance, Clinical Evaluation, Post-Market Surveillance and Technical Maps
    Documents for sterilization process: Procedure for EtO Sterilization, Procedure for Dry Heat Sterilization, Procedure for Ionizing Radiation Sterilization, Procedure for Filtration Sterilization
    Available product languages

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