Regulatory Compliance Information

ClaroNav Inc. is an MDSAP, ISO 13485:2016-certified medical device manufacturer committed to meeting and exceeding customer expectations for product quality, safety, and performance. Through continual improvement of our products and quality management system, we strive to deliver innovative solutions that meet the evolving needs of our customers in a rapidly changing global technology environment.

Quality Management System

ISO 13485 quality system certification (PDF format)

ISO 13485:2016 MDSAP CertificateEN ISO 13485:2016 Certificate

EU MDR 2017/745 - CE Certificates and Declarations of Conformity (DoC)

Navident CE Certificate - 28620194069Navident DoCNavident Accessories DoCMicronMapper DoC

United States - FDA

Establishment Registration and Listing – ClaroNav Inc. (Establishment Registration & Device Listing)


For product-specific information on regional availability and compliance, please contact your local distributor (Distributors) or ClaroNav at info@claronav.com