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Stay informed about key processes for Medical Devices and the latest FDA updates tailored for manufacturers.
Recent posts
Navigating the FDA 2026 Human Factors Guidance: The Risk-Based Approach
On May 29, 2026, the FDA issued its final guidance on the Content of Human Factors Information in Medical Device Marketing Submissions. This risk-based framework introduces three HF Submission Categories based on critical tasks and device changes. It helps manufacturers streamline CDRH submissions, clarifying when a simple summary suffices versus when comprehensive validation testing is mandatory, improving FDA review efficiency
SANRUBIO, LLC
Jun 93 min read
The QMSR Era: FDA’s Final Move to ISO 13485 Harmonization - Quality Management System and the FDA
As of February 2, 2026, the FDA has officially replaced the old Quality System Regulation (21 CFR 820) with the new Quality Management System Regulation (QMSR). This historic alignment with ISO 13485:2016 streamlines global compliance for medical device manufacturers. This article explores the core changes, the additional FDA-specific requirements, and how this "single audit" reality reduces costs and accelerates market access for international firms.
SANRUBIO, LLC
Mar 202 min read
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510(k) Submission with the eSTAR template: processing times.
The FDA Premarket Notification (510(k)) is essential for medical device manufacturers entering the U.S. market. It demonstrates that a new device is substantially equivalent to an existing, legally marketed device (predicate device) in terms of intended use and technical characteristics. Using the FDA's eSTAR template (mandatory as of October 1, 2023), the 510(k) process ensures device safety, effectiveness, and regulatory compliance. SANRUBIO, LLC offers expert guidance for
SANRUBIO, LLC
May 30, 20253 min read
Transformation of the FDA's Medical Device Quality Management System Regulation – QMSR Regulation
Transformation of the FDA's Medical Device Quality Management System Regulation – QMSR Regulation
SANRUBIO, LLC
Nov 21, 20242 min read
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