ZEVEX
Enteral Nutrition Delivery
Sensing - Ultrasonic and Optical
Surgical - Ultrasonic Devices
Fluid Management
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ZEVEX | Regulatory & Quality Standards

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Regulatory & Quality Standards

ZEVEX has an established quality track record and existing quality system certifications. ZEVEX customers consistently rank our service, innovation and product quality as superior when compared to other device manufacturers. ZEVEX products work, and they keep working.



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Because we view customer satisfaction as a critical aspect of successful performance, we chose to certify to ISO 9001:2000. This certification demonstrates our commitment to customer satisfaction as well as continually improving our processes. We have also developed the internal systems necessary to maintain compliance with the FDA's quality system regulation; and we are ISO 13485:2003 certified for contract design, manufacturing, distribution, and servicing of surgical, diagnostic, and therapeutic medical electro-mechanical systems and enteral nutrition delivery systems.

Our commitment to regulatory excellence provides value-added service to ensure that your device, component, or subsystem manufactured by ZEVEX will be in compliance with local and global regulatory guidelines.

Quality Policy
ZEVEX creates medical device technology to transform life. We design and produce innovative, high-quality products and services that customers value and that improve the lives of end-users. We accomplish this by applying world-class quality standards, continuous improvement, employee empowerment, and process execution.


"The ZEVEX team hit a home-run in exceeding our physicans' expectations. ZEVEX should count 'quality' as their overriding core competency as they make our system more reliable, safe, and effective in the field."
-- ZEVEX Customer