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Implement ISO 13485 effortlessly

No stress, and no consultant required.

Implement your own ISO 13485:2016 and achieve certification with the help of our guided documentation.
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ISO 13485 DOCUMENTATION

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!

POPULAR ISO 13485 FREE DOWNLOADS

Diagram of ISO 13485:2016 Implementation Process

Diagram of ISO 13485:2016 Implementation Process

Diagram, PDF format

Planning the implementation of ISO 13485:2016 is a crucial step in the success of your Medical Device Management System. With our ISO 13485:2016 Implementation Diagram you can see at a glance the step-by-step process to follow, ensuring nothing is forgotten.

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Checklist of Mandatory Documentation Required by ISO 13485:2016

Checklist of Mandatory Documentation Required by ISO 13485:2016

White paper, PDF format

Knowing what documents and records are necessary for ISO 13485:2016 can be confusing. This white paper is designed to clear up any misunderstandings regarding documents required by this standard, as well as outlining non-mandatory documents that are commonly used. It also offers help on structuring these documents, in a straight-forward and easy-to-follow format.

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Online compliance & maintenance software

Manage your ISO 13485 compliance projects with ease.

Conformio is an out-of-the-box online software solution that provides your small or mid-sized business with clear steps to implement compliance and privacy projects, and helps you maintain your compliance documents and processes all in one place.

ISO 13485 WEBINARS
Hear what the experts have to say

Feb
20
2019

How to use a Documentation Toolkit for the implementation of ISO 13485 [free webinar]

Available as: Live webinar, Webinar on demand

Date: Wednesday - February 20, 2019

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Apr
24
2019

How to sell ISO consulting services [free webinar]

Available as: Live webinar, Webinar on demand

Date: Wednesday - April 24, 2019

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You’ll save time, money, and effort in your
ISO 13485 implementation.

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