ISO 13485:2016 MEDICAL DEVICES QUALITY
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ISO 13485:2016 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 requirements and regulatory requirements applicable to medical devices and related services.
The standard is applicable to all manufacturers and providers of medical devices, components, contract services and distribution of medical devices.
• Increase access to more markets worldwide
• Savings in cost from reduction of defects and rejects
• Meet relevant regulatory requirements and customer expectations
• Demonstrate ability to produce safer and more effective medical devices
• Improve operation efficiency through continual improvement processes