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ISO 13485:2016 Medical Devices Quality Management Systems

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

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Benefits of ISO 13485

Market access for medical devices
Regulatory compliance (FDA, CE marking)
Risk-based approach to device safety
Consistent product quality
International recognition
Enhanced patient safety

ISO 13485 by Industry

Healthcare

ISO 13485 FAQ

Common questions about this standard

Related Standards

ISO 9001

The world's most recognized quality management standard for consistent quality and customer satisfaction.

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