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.
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Articles tagged with “medical-device-software”
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.
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.
CSV to CSA: Understanding FDA's New Validation Guidance
Analyze the transition from CSV to FDA's Computer Software Assurance (CSA). This guide details risk-based validation strategies and compliance impacts.
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.
IEC 62304 vs FDA CSA: A Medical Software Compliance Guide
Compare the IEC 62304 standard vs. FDA CSA guidance for medical software. Learn key differences in scope, risk classification, validation, and documentation.
Git Version Control for FDA and IEC 62304 Compliance
Examines how to apply Git version control workflows to satisfy FDA compliance under the 2026 QMSR, covering traceability, audit trails, CSA guidance, SBOM requirements, and standards like 21 CFR Part 11 & IEC 62304.
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.