Articles tagged with “samd”

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

post-market surveillance ai medical devices continuous learning locked algorithms algorithmic drift fda regulation samd medical device validation machine learning

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

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

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.

65 min read

2/1/2026

iec 62304 medical device software software lifecycle processes samd iso 14971 fda software guidance soup software medical device compliance

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.

15 min read

9/27/2025

ai in biopharma regulatory compliance generative ai gxp samd aiamd hipaa risk management life sciences

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

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.

35 min read

8/21/2025

samd software as a medical device imdrf medical device regulation digital health fda health tech