The ISO 13485 standard is for medical devices – quality management systems – requirements for regulatory purposes are the basis for regulatory compliance in local and most global markets. Exporting medical Devices to various countries is mandatory. ISO 13485 Certification is objective evidence of compliance with the requirements, regardless of the type or size of the organization.

This standard 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 services.

ISO 13485 certificate is universally recognized & it covers regulatory & statutory norms of most of the countries, your the product gets expanded market access.