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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 ToolkitISO 13485:2016 Documentation ToolkitEU MDR & ISO 13485 Integrated Documentation Toolkit
    Price (US$)
    		US$ 97US$ 897997 EUR
    Number of documents
    Editable MS Word and MS Excel policies, procedures, plans and forms that you can adapt to your company needs.
    		5 documents75 documents101 documents
    All documents required by ISO 13485
    Extended set of internal audit documents
    Commonly used non-mandatory procedures and forms
    Fully compliant withISO 13485:2016ISO 13485:2016ISO 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 languagesEnglishEnglishEnglish
    SEE DETAILSSEE DETAILSSEE DETAILS
    FOR IMPLEMENTATION OF PARTS OF THE STANDARD
    ISO 13485:2016 Internal Audit Toolkit
    US$ 97
    5 documents
    Editable MS Word and MS Excel policies, procedures, plans and forms that you can adapt to your company needs.
    Extended set of internal audit documents
    ISO 13485:2016
    Available product languages
    English
    SEE DETAILS
    FOR IMPLEMENTING A FULL STANDARD
    ISO 13485:2016 Documentation Toolkit
    US$ 897
    75 documents
    Editable MS Word and MS Excel policies, procedures, plans and forms that you can adapt to your company needs.
    All documents required by ISO 13485
    Extended set of internal audit documents
    Commonly used non-mandatory procedures and forms
    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
    Editable MS Word and MS Excel policies, procedures, plans and forms that you can adapt to your company needs.
    All documents required by ISO 13485
    Extended set of internal audit documents
    Commonly used non-mandatory procedures and forms
    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
    SEE DETAILS
    FOR CONSULTANTS
    ISO 13485 & MDR Integrated
    Documentation Toolkit     		Consultant White Label Toolkit
    Price (US$)997 EURGET THE PRICE
    Documentation can be usedfor your company only for your own company + for 10 of your clients
    Number of documents 101 documents101 documents
    All required ISO 13485:2016, ISO 14971:2019 and EU MDR documents
    White label templates
    Get all our documentation templates without the 13485Academy copyright – your clients will never know you got them from us.
    Division of tasks & time plan
    A plan that suggests which tasks should be done by a consultant and which by a client, with suggested timing for each.
    Sales presentation
    Presentation that will help you present your consulting services to potential customers.
    Consulting proposal
    A template that can be used to send a detailed proposal of your services to the potential client.
    Stakeholder mapping
    A 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.
    SEE DETAILS
    ISO 13485 & MDR Integrated
    Documentation Toolkit
    997 EUR
    Documentation can be used for your company only
    101 documents
    All required ISO 13485:2016, ISO 14971:2019 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 documents
    All required ISO 13485:2016, ISO 14971:2019 and EU MDR documents
    White label templates
    Get all our documentation templates without the 13485Academy copyright – your clients will never know you got them from us.
    Division of tasks & time plan
    A plan that suggests which tasks should be done by a consultant and which by a client, with suggested timing for each.
    Sales presentation
    Presentation that will help you present your consulting services to potential customers.
    Consulting proposal
    A template that can be used to send a detailed proposal of your services to the potential client.
    Stakeholder mapping
    A 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.
    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

    Kristina Zvonar Brkic 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
    Simple gave us an example of how the document could be structured and the different fields to include. Helped us not leave anything out.
    Wynn Johansson-Nunez
    SVENSKA DENTORAMA AB.

    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.

    Are my payment details secure?

    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.

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