On February 2, 2026, FDA’s revised 21 CFR Part 820 - now titled the Quality Management System Regulation (QMSR) - became effective. The key change is that FDA now incorporates ISO 13485:2016 by reference as the backbone of device CGMP requirements. If your organization has been “ISO-ish” but not fully [...]

FDA closed out 2025 - and opened the door to 2026 - with a clear signal to digital health and medical device sponsors: real-world performance of digital technologies is no longer a future consideration, it’s a regulatory expectation. In December, the U.S. Food and Drug Administration announced the launch of [...]

Across medical device and IVD inspections, U.S. Food and Drug Administration (FDA) continues to issue Form 483 observations and Warning Letters tied to risk management failures. These findings are not about missing templates, they reflect systemic breakdowns in how risk is identified, evaluated, justified, and maintained. Below are the three [...]

FDA closed out 2025 with a meaningful update for device sponsors: the final guidance, “Use of Real-World Evidence (RWE) to Support Regulatory Decision-Making for Medical Devices,” issued December 18, 2025, which supersedes the prior 2017 version. At QSN, we see this as more than a “nice-to-have” document. It’s a clearer [...]