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Stay informed about key processes for Medical Devices and the latest FDA updates tailored for manufacturers.
Recent posts
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
FDA removes a major barrier to the use of real-world evidence in medical device reviews
The FDA updates its real-world evidence policy for medical devices by removing the routine requirement for identifiable patient data. This change expands the regulatory use of de-identified databases and reshapes evidence strategies for medical device manufacturers seeking FDA clearance or approval.
SANRUBIO, LLC
Dec 29, 20253 min read
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What is a Pre-submission (FDA) and why should manufacturers use it before filing a 510(k) or De Novo?
The FDA Pre‑Submission (Pre‑Sub) process is a strategic tool under the FDA’s Q‑Submission Program that allows medical device...
SANRUBIO, LLC
Jul 29, 20252 min read
Cybersecurity for Medical Devices: what you need to know to meet the FDA's 2025 Guidance
Understand the FDA’s 2025 cybersecurity requirements for medical device submissions. Learn what manufacturers must include for successful FDA clearance.
SANRUBIO, LLC
Jul 4, 20253 min read
📱 Developing Home-Use Medical Devices: FDA regulations, design, and usability considerations
Learn how to develop FDA-compliant home-use medical devices with a focus on usability, safety, and effective regulatory strategies. This guide covers key FDA guidelines, including human factors engineering, IEC 62366-1 standards, and essential elements for a successful 510(k) submission. Discover best practices and how Sanrubio, LLC, based in Miami, can assist with pre-submission planning and FDA approval to streamline your market entry
SANRUBIO, LLC
Jun 30, 20253 min read
Key differences between the 510(k) and De Novo submission for FDA Medical Device Authorization
Discover the key differences between FDA’s 510(k) and De Novo pathways for medical device authorization. Learn when to choose each option, their requirements, timelines, and ideal use cases. From substantial equivalence in 510(k) to creating new classifications in De Novo, this guide provides essential insights for manufacturers. Ensure regulatory success with expert strategies and tailored support for your device’s U.S. market entry.
SANRUBIO, LLC
Jun 17, 20253 min read
What is Elsa and what has the FDA recently announced?
The FDA has introduced Elsa, a new AI tool designed to assist in medical device reviews, enhancing efficiency in 510(k), De Novo, and PMA pathways. Elsa operates securely without using confidential manufacturer data, aiming to speed up reviews and improve accuracy. While still early in development, it encourages manufacturers to prepare AI-ready submissions. This innovation marks a key step toward AI integration in regulatory processes, with ongoing human oversight and transp
SANRUBIO, LLC
Jun 9, 20254 min read
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
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