---
title: "ISO 13485: The Proposed Changes and What They Mean for You"
description: "ISO 13485: Proposed Changes and What They Mean for You - What we know about the coming changes and how to start preparing today."
image: https://www.thefdagroup.com/hubfs/Images/Covers/fda-WP-ISO13485ProposedChanges-Cover.jpg
---

| ![](https://www.thefdagroup.com/hubfs/Images/Covers/fda-WP-ISO13485ProposedChanges-Cover.jpg) | Get our free guide # ISO 13485: Proposed Changes and What They Mean for You What we know about the coming changes and how to start preparing today. Considerable changes are likely coming to ISO 13485, making it important for medical device manufacturers to start preparing accordingly. We’ve summarized the key takeaways from two Draft International Standards and presented them in an easy-to-follow guide. **What you'll find inside:** - Why ISO 13485 is being revised in the first place - The anticipated changes to ISO 13485 - What you can do right now to prepare for the changes ahead of time [Get my free guide »](https://www.thefdagroup.com/iso-13485-the-proposed-changes-and-what-they-mean-for-you#) |
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