Dedication to Quality

Our production facilities and procedures have been developed to provide the superior product quality and product tracking required for contemporary medical devices. We understand and have implemented processes compliant with global regulatory requirements such as:

  • FDA Quality System Regulation,
  • ISO 13485 Quality Management Systems Standard,
  • Medical Device Directive,
  • EN 62366 Usability Standard, and
  • IEC 60601-1 3rd Edition Electrical Safety Standard.

Cybersonics' products are 100% tested in a controlled environment to ensure they meet the high quality standards that the medical device industry demands. From electrical assembly to probe brazing and buffing, our processes are rigorously defined and continuously improved to provide the highest quality attainable.  TUV EN ISO13485 small