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Implement your own ISO 13485:2016 and achieve certification with the help of our guided documentation.
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Free consultations with our ISO 13485 experts are included. Simply schedule a private consultation and get the answers to your questions. Go from overwhelmed to understanding in one conversation, and learn practicable next steps.

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Free downloads

Want to find out which are the mandatory documents for ISO 13485 implementation? Check out our free downloads with white papers, case studies, checklists, templates, and other materials.

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See ISO 13485 Toolkits in action

You really can implement ISO 13485 by yourself – all you need is our documentation toolkits, along with included guidance and support. Our toolkits and other resources were developed for ease of use and to be understandable, with no expert knowledge required.

What’s more, here at the 13485Academy, we eliminate the stress and headache that can come with doing it yourself, and you’ll eliminate the huge price tag that comes with a consultant.

We’ve calculated your savings, and we estimate that you will save over 90% compared to the cost of a consultant. In other words, you’ll save thousands of dollars – with no drop in quality!

Why choose 13485Academy?

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