ISO 13485

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.


Improves the performance of the products & processes of a medical device company.

ISO 13485 works as a brand ambassador of your medical device hence your sales & marketing cost will reduce.

ISO 13485 certification gives faith to your customers that the device is safe for use & it meets the requirements of most of the recognized technical standards related to the medical device.

Reduced operating costs.

Improved stakeholder relationships.

Improved risk management.

Proven business credentials.

Customer satisfaction.

Legal compliance.

Ability to win more business.