Medical Device Standards Framework: Management, Regulatory & Product Compliance #2255860 (License: Personal Use)

The diagram illustrates the hierarchical and interdependent relationships among core standards governing medical devices: management standards (e.g., ISO 13485, ISO 14971), regulatory requirements (e.g., FDA CFR 21, EU MDR), product-specific standards (e.g., IEC 60601 series), and process standards (e.g., IEC 62304 for software). Arrows indicate how these standards satisfy, regulate, affect, or require one another in the context of medical device development, risk management, and market authorization. It serves as a strategic reference for quality managers, regulatory affairs specialists, and engineers navigating global compliance pathways.

Used on regulatory compliance pages, quality management system guides, or training materials for medical device manufacturers; targets professionals seeking to align internal processes with international standards for certification and market access.