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) other international quality system standards including ISO 13485.

  • 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

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