Quality Assurance | Regulatory Affairs | WEEE and RoHS2 Compliance | Safety and EMC

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 13485:2003 and ISO 9001-2000.
  • 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).
  • EC Certificate (PDF)
     
  • EC Certificate - L25 Needle Guide (PDF) 
     
  • ISO 13485:2003 (Includes CMDCAS certification for Canada) (PDF) 
     
  • ISO 9001:2008 (PDF) 


Harmonized Standards
European harmonized standards that each Sonosite-marked product complies with are listed below.