Knowledge Hub
Regulatory reality, written down
Field notes from building SaMD and connected-device software under ISO 13485 and IEC 62304. Articles open on sequenex.com.
Medical Device Software News · May 1, 2026
Apple App Store Medical Device Compliance
Apple’s new medical-device status requirement signals a shift in digital health compliance — app stores now actively influence regulatory readiness.
Read on sequenex.com ↗Biosensor & CGM Software · April 30, 2026Building CGM Software in 2026
Market outlook, software trends, and regulatory realities for hardware companies — including non-invasive technology developments.
Read on sequenex.com ↗SaMD Regulation and Compliance · April 20, 2026Wellness vs Medical Device Regulation
Wellness apps and medical devices are built on the same physiological signals — the difference lies in intent and claims.
Read on sequenex.com ↗Connected Medical Device Platforms · March 11, 2026Build vs. Buy: The Best Path to a Regulatory-Ready MedTech Platform
Connected-device compliance requirements and what they mean for your software foundation decision.
Read on sequenex.com ↗SaMD Regulation and Compliance · February 25, 2026Software Remediation for Medical Devices
The readiness gap most teams discover too late: working software isn’t submission-ready software.
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