Quality Statement

The Ultrasonix Medical Corporation Quality Management System is registered to the ISO 13485:2003 and has been approved in conformity with the requirements of Annex V, section 3.2 – Production quality assurance of Council Directive 93/42/EEC concerning medical devices and FDA 21 CFR Part 820 Quality System Regulation. The QMS provides a structure for excellence in product design and development, quality of manufactured goods, delivery times and elimination of non-value added costs.

Quality Policy

Ultrasonix Medical Corporation is dedicated to being a leader in the development of ultrasound systems to help Physicians and Clinicians deliver better patient care via:

 

  • Innovation and scientific excellence
  • The Development and Manufacturing of High Quality Ultrasound Systems
  • Open and honest customer and supplier relationships
  • Employee involvement and development
  • Compliance with all relevant regulatory requirements

 

The management fulfils its commitment to quality also in such a way that all workers know, understand and carry out the quality policy.