REGULATORY

QUALITY POLICY

ivWatch’s mission is to create high quality sensor technology and exceed customer expectations under a compliant and effective Quality Management System; to provide continuous monitoring and eliminate patient harm associated with IV infiltrations and extravasations.

–Gary Warren, President & CEO, ivWatch

Quality/Regulatory Clearances and Certificates

FDA 510(k) Clearance February 2015 – View PDF

FDA 510(k) Clearance February 2016 – View PDF

FDA 510(k) Clearance December 2016 – View PDF

ISO 13485:2003 Certification – View PDF

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