REGULATORY
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: 2016 MDSAP Certification – View PDF
EN ISO 13485:2016 Certification – View PDF
CE Marking – View PDF
Australian TGA Certificate – View PDF
Canada Medical License – View PDF