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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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Compliance Guides
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Major Regulatory Bodies
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Understanding the major regulatory organizations that govern medical devices and healthcare facilities.
Food and Drug Administration
U.S. federal agency responsible for protecting public health through regulation of medical devices, drugs, and biological products.
International Organization for Standardization
Develops international standards including ISO 13485 for quality management systems in medical devices.
International Electrotechnical Commission
Publishes international standards for electrical and electronic equipment including IEC 60601 for medical electrical equipment.
Browse our comprehensive collection of regulatory guides organized by compliance category.
Our regulatory experts can help you navigate complex compliance requirements and ensure your facility meets all necessary standards.
Contact Compliance ExpertsOccupational Safety and Health Administration
Ensures safe working conditions including bloodborne pathogen standards for healthcare workers.
Health Insurance Portability and Accountability Act
Federal law protecting sensitive patient health information from disclosure without consent.
Clinical Laboratory Improvement Amendments
Federal standards for clinical laboratory testing quality, accuracy, and reliability.
