Regulatory and Compliance

Quality Assurance

SonoSite’s quality vision is simple:

Our job is to anticipate and meet our customers’ requirements through continuous improvement in every aspect of our business practices.

  • The quality assurance management system that supports the design, development, manufacture, testing and release of SonoSite products is comprehensive, robust and meets the requirements of both regulatory agencies and customers.

  • SonoSite products are designed and manufactured in accordance with established United States FDA quality system regulations (21 CFR 820) and other international quality system standards including ISO 13485 and ISO 9001.

  • SonoSite product designs are verified and validated and meet design input requirements and specifications, intended uses, and user needs.

  • The materials used to manufacture SonoSite products meet the requirements of the quality system acceptance activities (inspection and test).

  • Delivered SonoSite products meet the requirements of the quality system acceptance activities (inspection and test).

 

Applicable Certificates