REGULATORY

QUALITY POLICY

ivWatch, LLC is committed to providing a high-quality medical device that meet or exceed our customer requirements while complying with all statutory and regulatory requirements. We are dedicated to maintaining the effectiveness of the Quality Management System by rigorous internal auditing programs, monitoring of our performance against measurable objectives and promoting employee involvement and learning.
–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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