Articles tagged with “ai-medical-devices”

IEC 62304 Edition 2: 2026 Medical Device Software Changes

Review the key changes in IEC 62304 Edition 2 for medical device software. This 2026 guide covers revised safety levels, AI/ML compliance, and expanded scope.

35 min read

4/3/2026

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FDA AI/ML SaMD Guidance: Complete 2026 Compliance Guide

Review the evolving FDA regulatory framework for AI/ML SaMD. This guide explains PCCPs, total product lifecycle management, and 2026 compliance standards.

45 min read

3/5/2026

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FDA Pathways for AI SaMD: 510(k), De Novo & PMA Guide

A guide to FDA regulatory pathways for AI/ML SaMD. Compare 510(k), De Novo, and PMA submission requirements for artificial intelligence medical devices.

30 min read

3/5/2026

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FDA 510(k) AI Submissions: Guidelines and Best Practices

Analyze 2026 strategies for AI-assisted 510(k) submissions. Covers FDA guidance, generative AI tools, and mandatory human oversight protocols.

35 min read

2/27/2026

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AI Post-Market Surveillance: Locked vs. Continuous Learning

Compare post-market surveillance for locked vs. continuous learning AI devices. Analyze regulatory guidelines, algorithmic drift, and validation strategies.

60 min read

2/25/2026

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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

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QMS for AI/ML Medical Devices: Regulatory & Design Guide

Learn QMS requirements for AI/ML medical devices, including FDA regulations, ISO 13485, data lifecycle management, and model validation strategies.

55 min read

2/13/2026

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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

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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

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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

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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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