IMS’s Quality Management System is certified to ISO 13485:2016 for the design, development, installation, and support of medical imaging software and communication software.
IMS holds a valid Establishment Licence with Health Canada (MDEL) and is compliant with the Canadian Medical Device Regulations (CMDR SOR/98-282).
IMS holds a valid Facility Registration with the FDA and is compliant with the FDA Quality System Regulations (CFR Title 21 Part 820).
IMS designs, develops, and services its products in compliance with HIPAA, HITECH, and PHIPA regulations.
CloudVue is an FDA-cleared Class II medical device (K203058).
