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

The quality management system underlying SpinaFX Medical Inc’s 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.”
 
An internationally recognized quality standard, ISO 13485:2016 is a set of requirements for quality management systems for medical devices. To achieve this independent, third-party certification, companies must demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
 
“ISO/MDSAP certification is a critical prerequisite enabling our pursuit of Health Canada, EU MDR and U.S. FDA medical device licensing and approvals,” said SpinaFX CEO Jeff Cambra. “This outcome is evidence of the experience and deep capabilities of the SpinaFX team and our partners.”
 
“International certification of our quality management system along with Health Canada Special Access Program approval for Triojection were critical milestones for our Series A investors,” said SpinaFX executive chairman Igor Keselman. “Our message to current and future investors: SpinaFX is committed to quality and is prepared to deliver on its goals.”