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Harmonizating the QSR CFR 820 with ISO 13485:2016

Navigating the Transition

Taken from Brian Newbery, Founder of Fast-Track QMS Consultants

As we enter a new era in the regulatory landscape for medical devices, the Food and Drug Administration (FDA) is undergoing a significant transition. The Quality System Regulation (QSR) under 21 CFR Part 820 is on its way to alignment with the international standard ISO 13485:2016. This shift, anticipated for quite some time, brings about the birth of the Quality Management System Regulation (QMSR).

Initially slated for release by the end of 2023, the finalization of the QMSR has been slightly delayed. However, there's light at the end of the tunnel, as the regulation is currently under review at the White House, and we can expect its official release in the coming weeks.

Many medical device companies, already compliant with CFR 820, are proactively addressing any gaps in their systems to align with the ISO 13485:2016 Quality Management System (QMS). To facilitate this transition, we've prepared a guide to highlight the main differences between the two standards and assist companies in understanding the adjustments required for their QMS.

Understanding the Landscape

ISO 13485:2016 vs. FDA CFR 820: A Quick Overview

ISO 13485:2016 is a globally recognized voluntary standard for medical devices. On the other hand, the FDA CFR 820 is a mandatory regulation that governs medical device manufacturers and suppliers aiming to market their products in the United States.

While there are substantial similarities between 21 CFR Part 820 and ISO 13485:2016, there are also key differences and additions that necessitate attention and adaptation. Below are reference summaries that outline ISO 13485:2016 elements, their corresponding FDA requirements, and any notable distinctions.

Check the document below!

Navigating the Changes

A Summary Guide for Transitioning Your QMS

This guide serves as a concise resource, offering a high-level comparison to aid in comprehending the alterations required for compliance. Keep in mind that this is a summary guide, and for detailed comparisons, it's advisable to refer to the official documents.

In some instances, details have been abbreviated for clarity, and key ISO 13485 requirements have been highlighted. If you are in the process of modifying your QMS, it's crucial to refer to the official documents for a thorough understanding of the changes.

As the industry adapts to these regulatory transformations, AF Pharma and Fast-Track QMS Consultants remains committed to providing support and expertise to ensure a seamless transition for your organization.

Stay tuned for more insights and updates as we navigate this transformative period in medical device regulations.

Comparison table

13485 vs 820
Download PDF • 982KB

ISO certificate
ISO 13485

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