+1 425 951 1200 LOG IN UNITED STATES Products Education Evidence Specialties Sales Support About Blog Contact Us Home About REGULATORY AND COMPLIANCE Quality Assurance | Regulatory Affairs | WEEE and RoHS2 Compliance | Safety and EMC 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 EC CERTIFICATE EC CERTIFICATE L25 Needle Guide ISO 13485 ISO 9001 NEED INFORMATION OR HELP? Connect with an ultrasound expert today. Contact Us STAY INFORMED Get product updates, the latest ultrasound news and more! Subscribe LIKE THIS PAGE? Share It! Connect with SonoSite Fujifilm SonoSite is a proud member of the National Patient Safety Foundation's Patient Safety Coalition. FUJIFILM SonoSite, Inc. the SonoSite logo and other trademarks not owned by third parties are registered and unregistered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions. All other trademarks are the property of their respective owners. © 2018 FUJIFILM SonoSite, Inc. All Rights Reserved Privacy Policy Modern Slavery Act Statement Accessibility Terms of Use