Quality

Effective, agile and compliant processes

Micro-X Quality

Effective, agile and compliant processes

Quality is our cornerstone

Micro-X products are manufactured to the highest of standards, with safety and quality at the forefront of everything we do.

Our products undergo thorough quality testing before being released. We are committed to delivering excellence to our customers through our products, processes, services and relationships. Our rigorous approach to quality is audited and confirmed by our notified bodies. We have a methodology that embraces continuous improvement and welcome your feedback.

Our Quality Management System is certified to ISO EN 13485:2016 QMS for Medical Devices and ISO9001:2015 QMS.

The Rover Mobile DR X-ray and second generation Rover Plus are CE marked under the EU Medical Device Regulation 2017/745 (MDR), included in the Australian Register of Therapeutic Goods (ARTG) and cleared by the U.S. Food and Drug Administration (FDA).

Quality and Regulatory Certificates

Quality Management System for Medical Devices - ISO 13485:2016 (EN ISO 13485:2016)
March 30, 2023
Quality Management System - ISO 9001:2015 Certificate
November 2, 2022
EU Quality Management System Certificate
October 17, 2023
ETL Certificate
October 30, 2023
Conformity Assessment Certificate
July 17, 2023

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