ISO 13485

What is ISO 13485?

ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. This standard is specifically designed for organizations that manufacture and service medical devices.

ISO 13485 ensures that medical device manufacturers and service providers can demonstrate their ability to provide products and services that consistently meet customer and regulatory requirements.

Key Features:

• Risk management framework
• Quality assurance procedures
• Traceability requirements
• Regulatory compliance