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ISO 13485: 2003 - Quality Management Standard for Medical Devices

ISO 13485:2003 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.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization..

Benefits of 13485: 2003 certifications:

  • Guarantees high quality of provided services and products.
  • Increases effectiveness across the whole organization
  • Increases your customers‘ trust in you as a safe supplier or producer.
  • Increase access to more markets worldwide with certification
  • Outline how to review and improve processes across your organization
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations