Medical Standards Hub
Your comprehensive guide to medical device regulations, healthcare compliance standards, and facility requirements. Navigate FDA, ISO, IEC, HIPAA, CLIA, and OSHA requirements with expert guidance.
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Major Regulatory Bodies
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Key Regulatory Bodies
Understanding the major regulatory organizations that govern medical devices and healthcare facilities.
FDA
Food and Drug Administration
U.S. federal agency responsible for protecting public health through regulation of medical devices, drugs, and biological products.
ISO
International Organization for Standardization
Develops international standards including ISO 13485 for quality management systems in medical devices.
IEC
International Electrotechnical Commission
Publishes international standards for electrical and electronic equipment including IEC 60601 for medical electrical equipment.
Standards by Category
Browse our comprehensive collection of regulatory guides organized by compliance category.
OSHA
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