The clock is ticking. On February 2, 2026, the FDA's new Quality Management System Regulation (QMSR) becomes mandatory for all medical device manufacturers. If your organization is still operating under the old Quality System Regulation (21 CFR Part 820), you have just over one year to complete your transition. This isn't a minor regulatory update - it's the most significant change to FDA quality requirements in nearly 30 years. The FDA QMSR replaces 21 CFR Part 820 with ISO