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    Pricing & options for ISO 13485 documentation toolkits

    FOR YOUR OWN COMPANY

    FOR IMPLEMENTATION OF PARTS OF THE STANDARD

    FOR IMPLEMENTING A FULL STANDARD

    ISO 13485:2016 Internal Audit Toolkit
    ISO 13485:2016 Documentation Toolkit
    EU MDR & ISO 13485 Integrated Documentation Toolkit
    Price (US$)
    US$ 97
    US$ 897
    997 EUR
    Number of documents
    5 documents
    75 documents
    101 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 13485:2016
    ISO 13485:2016
    ISO 14971:2019
    EU MDR 2017/745
    MDR documents including Clinical Evaluation, Post-Market Surveillance and Technical maps
    ISO 14971 risk management documents including Procedure for FMEA Risk Assessment
    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
    English
    English
    English
    SEE DETAILS
    SEE DETAILS
    SEE DETAILS
    FOR IMPLEMENTATION OF PARTS OF THE STANDARD
    ISO 13485:2016 Internal Audit Toolkit
    US$ 97
    5 documents
    Extended set of internal audit documents
    Fully compliant with ISO 13485:2016
    Available product languages
    English
    SEE DETAILS
    FOR IMPLEMENTING A FULL STANDARD
    ISO 13485:2016 Documentation Toolkit
    US$ 897
    75 documents
    All documents required by ISO 13485
    Commonly used non-mandatory procedures and forms
    Fully compliant with ISO 13485:2016
    Available product languages
    English
    SEE DETAILS
    FOR IMPLEMENTING A FULL STANDARD
    EU MDR & ISO 13485 Integrated Documentation Toolkit
    997 EUR
    101 documents
    All documents required by ISO 13485, ISO 14971 and EU MDR
    Commonly used non-mandatory procedures and forms
    Fully compliant with ISO 13485:2016, ISO 14971:2019 and EU MDR 2017/745
    MDR documents including Clinical Evaluation, Post-Market Surveillance and Technical maps
    ISO 14971 risk management documents including Procedure for FMEA Risk Assessment
    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
    English
    SEE DETAILS

    FOR CONSULTANTS

    ISO 13485 & MDR Integrated Documentation Toolkit
    Consultant White Label Toolkit
    Price (US$)
    997 EUR
    GET THE PRICE
    Documentation can be used
    for your company only
    for your own company + for 10 of your clients
    Number of documents
    101 documents
    101 documents
    All required ISO 13485:2016, ISO 14971:2019 and EU MDR documents
    White label templates
    Division of tasks & time plan
    Sales presentation
    Consulting proposal
    Stakeholder mapping
    SEE DETAILS
    ISO 13485 & MDR Integrated Documentation Toolkit
    997 EUR
    Documentation can be used for your company only
    101 full documents
    All required ISO 13485, ISO 14971 and EU MDR documents
    Consultant White Label Toolkit
    GET THE PRICE
    Documentation can be used for your own company + for 10 of your clients
    101 full documents
    All required ISO 13485, ISO 14971 and EU MDR documents
    White label templates
    Division of tasks & time plan
    Sales presentation
    Consulting proposal
    Stakeholder mapping
    SEE DETAILS

    Click on “Download Free Toolkit Preview”, submit your name and email address, and you’ll have access to a free preview of our ISO 13485 toolkit documents. Before you make a decision to buy, these previews will let you see how the templates look, and how simple they are to complete.

    DOWNLOAD FREE TOOLKIT PREVIEW

    ISO-13485-expert-advisera-round

    Kristina Zvonar Brkic
    Lead ISO 13485 expert

    NOT SURE WHICH IS THE BEST OPTION FOR YOU?

    Get free expert help with your ISO 13485 implementation

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    WHAT OUR CUSTOMERS SAY ABOUT US

    The template has made it easier to know what information is needed. I have found Advisera's 13485Academy very helpful in providing information for helping me understand what is needed to transition our FDA 21 CFR, Part 820 to also be compliant with ISO 13485:2016. The EU MDR Checklist of Mandatory Documents has been a great guide for getting all documents ready to send in for EU certification. A lot of great information and guidance can be found at 13485Academy.
    Catherine Nelson
    Quality Coordinator
    Titronics
    The toolkit was extremely helpful in that the procedures were easy to follow, had a good structure and allowed me to make adjustments to tailor them to my needs. I didn’t have to start from scratch or spend hours searching the web for templates. The procedures integrated ISO 13485 and the MDR with ease.
    RJ Blake
    Quality Manager
    Rehan Electronics Ltd.
    The toolkit provides good guidelines to QMS development.
    Dr. Francis Wong
    Koln 3D Technology (Medical) Limited

    FAQs: Buying ISO 13485 documentation toolkits

    When and how will I get the toolkit?

    Immediately after the transaction is processed, you will receive an email with a download link. It could not be quicker or simpler.

    What kinds of payment can you accept?

    We take all major credit cards, PayPal payment, and we can accept a wire transfer from your bank account.

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    We proudly use Secure Socket Layer (SSL) technology, which is the industry standard. This technology encrypts your credit card information, keeping it secure, and sends it directly to the payment processor. We never store – or even see – your payment information.

    Which currencies can I use?

    We gladly accept more than 50 commonly used currencies, including the US Dollar, the Euro, the British Pound, and the Swiss Franc.

    Is the toolkit compliant with the newest changes in the ISO standard?

    Yes. Also, you are entitled to receive free updates of those toolkits for one year after your purchase date.

    About 13485Academy

     

    13485Academy is one of the Academies of Advisera.com. Advisera specializes in helping organizations implement top international standards and frameworks such as EU GDPR, ISO 27001, ISO 9001, ISO 13485, ISO 14001, ISO 45001, IATF 16949, ISO/IEC 17025, AS9100, ISO 20000 and ITIL. Over the years, Advisera has become a global leader in the provision of web-based training and documentation developed by the leading experts.

    Our products are of best-in-class quality. With a proven performance record of successful implementations in more than 100 countries, our world-class customer support ensures success. Read more about the 13485Academy here.

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