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 global market.
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 13485:2003 requirements and Canadian and European regulations. Object Research System's Quality Management System also complies to FDA's Quality System Requirements.
|Canada||Health Canada||Medical Devices Active Licence Listing (MDALL)|
EC Declaration of Conformity
Authorized Representative Certificate
|United States||Food and Drug Administration (FDA)||
Establishment Registration & Device Listing
510(k) Premarket Notification
We maintain our system conformance with industry standards, including DICOM and IHE.
We are always seeking candidates with strong scientific, managerial, and leadership skills.