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FDA Cybersecurity Compliance Standards: 2025 Complete Guide
FDA's new cybersecurity compliance standards carry criminal penalties and RTA threats that can destroy medical device companies. With the...
Jul 14, 20258 min read
FDA Cleared vs FDA Approved vs FDA Granted: 2025 Complete Guide
In FDA device speak, cleared ≠ approved ≠ granted. Mixing these terms can misbrand your product. FDA cleared means 510(k) approval for...
Jul 11, 20257 min read
What Is FDA STeP Program (Safer Technologies Program)? Complete Guide 2025
FDA's Safer Technologies Program (STeP) is a voluntary program for devices reasonably expected to significantly improve safety of...
Jul 10, 20257 min read
What Is an FDA Medical Device Recall? 2025 Crisis-Prevention Guide
An FDA medical device recall is usually a voluntary action by a firm to remove or correct a product that violates FDA law , with FDA...
Jul 10, 20258 min read
What Is an SBOM? FDA Requirements for Medical Devices (2025 Guide)
A Software Bill of Materials (SBOM) is a machine-readable inventory of every software component in your device—proprietary, OTS, and...
Jul 9, 20259 min read
What Is cGMP for Medical Devices? QSR Today, QMSR in 2026
In FDA device world, “ cGMP ” obligations are implemented via the Quality System Regulation (21 CFR 820) . On Feb 2, 2026 , FDA’s Quality...
Jul 9, 20257 min read
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