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

Product Certifications and Approvals

Australia - Devices listed in ARTGCanada - Medical Device LicensesEurope - CE Marking certificatesEurope - Declarations of ConformityMexicoTaiwan - FDAThailandUnited Arab Emirates - MOH classification certificateUnited States - FDA 510(k) cleared devices

Global Regulatory Representatives

Shown below are in-country regulatory representatives for issues and incident reporting.

Australia - Sponsor Representative

Emergo Australia
Sydney, Australia
Telephone: +61.2.9006.1662

Europe - Authorized Representative

Emergo Europe
Westervoortsedijk 60, 6827 AT Arnhem
The Netherlands