Quality Assurance

for the global healthcare market

Our Quality Management system has been approved and certified to comply with the requirements of EN ISO 13485:2016.

All our medical devices have obtained regulatory clearance for those markets where they are sold and deployed, e.g. as class II medical devices in the United States, or IIa medical devices in the European Union and Switzerland.

For further regulatory information, please contact us at quality@cordiana.com.


EN ISO 13485:2016


EU Directive 93/42/EEC


FDA Letter (K201060)