Design and Manufacture of Medical Devices (ISO 13485)

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, regulatory requirements applicable to medical devices and related services.

The primary objective is to facilitate harmonized medical device regulatory requirements for quality management systems. All requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization.

ISO 13485 helps to

  • 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

 IQC shall issue un-accreditated cetificate of compliance on satisfactory compliance to the above standard and documented procedures of IQC.

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