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SpinaFX Medical Achieves ISO 13485:2016/MDSAP and EN ISO 13485:2016 Certification

November 9, 2022

TORONTONov. 9, 2022 /PRNewswire/ – Minimally invasive image-guided treatment solution and technology company, SpinaFX Medical Inc. (SpinaFX), today announced the quality management system underlying its Triojection® system has been certified compliant with ISO 13485:2016/Medical Device Single Audit Program (MDSAP) for U.S. and Canada and EN ISO 13485:2016 for Europe. The audit was conducted by Intertek Group Plc and issued no findings.

“This is a foundational milestone for SpinaFX,” said SpinaFX Chief Operating Officer John Soloninka, who led SpinaFX’s ISO/MDSAP certification program. “The achievement is a testament to the high-quality, cross-functional and collaborative effort of our team and our contract manufacturer, Starfish Medical. I sincerely thank all staff and partners for their efforts.”

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