quality management system

Blue Medical recognizes its responsibility as a manufacturer and developer of quality products and has developed and documented a Quality Management System which is maintained and enforced by our Quality Assurance team.


Our Quality Management System complies with the international standard ISO 13485:2012, Medical Devices – Quality Management Systems – Requirements for regulatory purposes and the current Council Directive 93/42/EEC. Management of Blue Medical and all of its employees are committed to maintain the excellent quality of our products, to meet our stated quality objectives, and to comply with applicable regulatory requirements, as defined in our Quality Policy.


Certificates are issued by Notified Body BSI GMBH