Regulatory Compliance

Ensuring product quality and complying with regulatory requirements

Object Research Systems has implemented a Quality Management System (QMS) to better satisfy our customers' needs and to comply with the regulatory requirements of our international market.

Quality Management System

Our Quality Management System is driven by a quality policy and quality objectives and is audited regularly by an authorized registrar to certify our compliance to ISO 13485 requirements. Object Research System's Quality Management System also complies to the FDA's Quality System Requirements.

ISO 13485:2016 MDSAP Certificate of Registration (includes regulatory requirements for Canada and the United States)
ISO 13485:2016 / EN ISO 13485:2016 Certificate of Registration

Regional Compliance

Country/Territory Authority Certification/Registration
Canada Health Canada Medical Devices Active Licence Listing (MDALL)
United States Food and Drug Administration (FDA) Establishment Registration & Device Listing
510(k) Premarket Notification

Conformance Documents

We maintain our system conformance with industry standards, including DICOM and IHE.

DICOM Conformance Statement for ORS Visual 1.5
IHE Integration Statement for ORS Visual 1.5

Be Part of Our Success!

We are always seeking candidates with strong scientific, managerial, and leadership skills.