Articles tagged with “cybersecurity”

FDA Digital Health Guidance: 2026 Requirements Overview

Analysis of FDA digital health guidance covering SaMD, AI, and cybersecurity. Understand 2026 updates, risk categorization, and regulatory compliance pathways.

50 min read

2/24/2026

fda guidance digital health samd software as a medical device regulatory compliance clinical decision support medical device software ai medical devices cybersecurity

IEC 62304: Medical Device Software Life Cycle Processes

A comprehensive guide to the IEC 62304 standard for medical device software, updated for 2026. Covers life cycle processes, safety classification, Edition 2.0 draft changes, FDA QMSR alignment, IEC 81001-5-1 cybersecurity, and regulatory compliance across FDA and EU MDR.

100 min read

8/25/2025

iec 62304 medical device software software life cycle samd regulatory compliance risk management software safety cybersecurity iec 81001-5-1 fda qmsr