SpinaFX Medical’s Triojection Quality Management System Certified

SpinaFX Medical’s Triojection-associated quality management system has been certified compliant with ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP).

The Triojection system provides minimally-invasive, image-guided needle injection treatments to individual discs in the spine.

The ISO/MDSAP certification is “a critical prerequisite” for gaining regulatory licensing and approval in the U.S., Canada, and Europe for the device, the Canada-based company said.

The audit was conducted by Intertek, which provides testing, inspection and certification services.