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.
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Articles tagged with “samd”
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.
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.
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.
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.
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.
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.
IEC 62304 Guide: Medical Device Software Safety Standard
Explore the IEC 62304 standard for medical device software. Learn about safety classifications, lifecycle processes, and compliance for FDA and EU MDR.
AI Regulatory & Legal Frameworks for Biopharma in 2025
Examines the 2025 AI regulatory frameworks for biopharma in the U.S., EU, U.K., and Canada. Details compliance obligations for GenAI, GxP, and SaMD.
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.
An Introduction to Software as a Medical Device (SaMD)
Comprehensive guide to Software as a Medical Device (SaMD): IMDRF definition, FDA QMSR and PCCP frameworks, EU MDR/AI Act compliance, real-world examples, and 2025-2026 regulatory updates.