SonoSite
- About Sonosite
- Product Line
- M-Turbo™
M-Turbo™
Ideal for broader applications, this versatile powerhouse with brilliant image quality can help you perform anything from abdominal to vascular, to cardiac exams with speed and accuracy.
- S Series™
S Series™
For situations where you need a streamlined device with fewer buttons, bells and whistles, amazingly clear image quality and a fast, easy way to transport patient data.
- M-OB/GYN Office™
M-OB/GYN Office
More specialized ultrasound = more focused medicine. We engineered the M-OB/GYN office ultrasound tool to be just what you need in a point-of-care system.
- MicroMaxx®
MicroMaxx®
A laptop-sized, durable unit representing the technology crossover point between hand-carried ultrasound and larger, high-performance, cart-based systems.
- More Products
More Products
SonoSite software and previous generations.
- Trade In, Trade Up
- M-Turbo™
- Resources
- globe
The SonoSite Regulatory & Compliance web pages provide SonoSite customers information on key elements of medical device compliance.
Regulatory Compliance
Regulatory & 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 13485:2003 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).
MORE INFORMATION & DOCUMENTATION
The links below provide copies of SonoSite's quality system certificates.