Published On:
February 7, 2025
Countdown to Compliance: FDA’s Quality Management System Regulation (QMSR)
The clock is ticking, and there’s no time to waste! We’re just one year away from the game-changing FDA Quality Management System Regulation (QMSR), set to take effect on February 2, 2026. This new rule aligns with ISO 13485:2016, paving the way for a smoother path toward compliance for medical device manufacturers both in the U.S. and globally.
What Does This Mean for You?
- Unified Regulatory Framework: The QMSR creates a streamlined process that lightens the load for manufacturers.
- Global Best Practices: This regulation impacts all U.S. medical device manufacturers and integrates best practices globally into your operations.
Are You Prepared?
Now is the time to start preparing for compliance. Contact ECI today to discuss strategies tailored to your needs. Our team of quality and regulatory experts are ready to support you.
Read more: FDA QMSR Final Rule
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