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$)
US$ 197US$ 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$ 197
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

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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.