FDA QMSR: Why You’re Already Behind

The FDA’s new Quality Management System Regulation (QMSR) will soon be in effect, and the countdown to compliance is already underway. By February 2, 2026, all medical device manufacturers must meet the updated requirements of 21 CFR Part 820, which now aligns closely with ISO 13485:2016. While the deadline may seem far away, organizations that delay risk falling behind, which will lead to compliance gaps, rushed transitions, and increased regulatory scrutiny.

In this on-demand webinar, you’ll get a clear, practical overview of what the QMSR means for your organization. The session breaks down what’s changing, why the FDA made this shift, and the actions you should be prioritizing now. Whether you’re just starting to evaluate your quality system or are already deep into your transition, the recording provides insights and guidance that will help you move forward with confidence.

By watching, you’ll gain a solid understanding of how the new regulation impacts your processes, documentation, and overall quality management strategy. You’ll also hear what the FDA expects during this transition period and what steps are most critical as the compliance deadline approaches. In this recording, you’ll learn: What’s changing under the new FDA QMSR and why it matters for device manufacturers How QMSR aligns with ISO 13485:2016 and what that means for your quality system Practical steps to begin preparing for compliance now Key factors to consider when planning your transition strategy What to expect from the FDA as we move closer to the February 2, 2026 deadline

Staying ahead of regulatory changes is critical in today’s medical device landscape, and the QMSR is no exception. This recording equips you with the knowledge and direction needed to start or strengthen your transition plan before time runs out.

The earlier you act, the smoother your path to compliance will be.