Let’s take a closer look at one of the most impactful FDA-related changes coming at the start of 2026 and what it actually means in practice.
In the U.S., FDA’s new QMSR comes into force on 2 February 2026. While it aligns Part 820 with ISO 13485, ISO certification alone won’t automatically meet all FDA expectations.
What is QMSR? Quality Management System Regulation. It is a new FDA regulation that harmonizes U.S Medical device quality system requirements with ISO 13485:2016.
So, what does preparation really look like?
If you already have a QMS compliant with the current FDA QSR, now is the right time to run a focused gap analysis. This helps identify what is missing, what needs to change, and how to address it before February 2026. If you don’t have a QMS and plan to enter the U.S. market in 2026, this is the moment to build a clear plan for meeting QMSR requirements, not after the rule takes effect.
Early preparation always means less work later and far fewer surprises during inspections and submissions.
At Nometech, this is exactly the type of work we support, from practical gap analyses to building FDA-ready quality systems for U.S. market entry.
If 2026 is already on your radar, we’d be happy to exchange thoughts about the change or help you plan the next steps.
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