Articles tagged with “ai-medical-devices”

FDA SaMD Classification: AI & Machine Learning Guide

Understand FDA SaMD classification for AI/ML devices. Review risk levels (Class I-III), 510(k) pathways, and regulatory guidelines for medical software.

20 min read

2/9/2026

fda regulation samd classification ai medical devices machine learning 510(k) clearance de novo pathway software as a medical device regulatory compliance

EU MDR & AI Act Compliance for AI Medical Devices

Understand EU MDR and AI Act compliance for AI medical devices. Explains classification, conformity assessment, and technical documentation requirements.

40 min read

2/6/2026

eu mdr ai medical devices eu ai act medical device regulation software as a medical device regulatory compliance conformity assessment mdcg guidance risk management samd

AI Medical Device Cybersecurity: Regulations & Risks

Learn cybersecurity requirements for AI medical devices. Covers FDA guidance, EU regulations, SBOM mandates, and defenses against adversarial AI attacks.

60 min read

2/6/2026

ai medical devices medical device cybersecurity iomt security fda guidance adversarial machine learning sbom eu ai act risk management saamd

AI Medical Devices: 2025 Status, Regulation & Challenges

Analysis of AI medical devices in 2025. Learn about market growth, 950+ FDA-cleared devices, new regulations like the EU AI Act, and key clinical challenges.

50 min read

10/30/2025

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