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$) | US$ 197 | US$ 897 | 997 EUR |
| Number of documents Editable MS Word and MS Excel policies, procedures, plans and forms that you can adapt to your company needs.
| 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$ 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 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 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.
Kristina Zvonar Brkic
Lead ISO 13485 expert
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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
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.
Quality Manager
Rehan Electronics Ltd.
The toolkit provides good guidelines to QMS development.
Dr. Francis Wong
Koln 3D Technology (Medical) Limited
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.
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.