Minimally invasive image-guided treatment solution and technology company, SpinaFX Medical has 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.
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ISO 13485 Medical devices international standard text on blackboard, concept background
The audit was conducted by Intertek Group 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 recognised 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.
SpinaFX CEO Jeff Cambra, said: "ISO/MDSAP certification is a critical prerequisite enabling our pursuit of Health Canada, EU MDR and U.S. FDA medical device licensing and approvals. This outcome is evidence of the experience and deep capabilities of the SpinaFX team and our partners."
SpinaFX executive chairman Igor Keselman, added: "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. Our message to current and future investors: SpinaFX is committed to quality and is prepared to deliver on its goals."
