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.
| TORONTO, Nov. 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.” 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.” About SpinaFX Headquartered in Ontario, Canada, SpinaFX is a treatment solution and technology company bringing innovative, minimally invasive image-guided treatments to patients with back pain due to contained herniated discs. Forward-Looking Statement All forward-looking statements are based on current beliefs as well as various assumptions made by, and information currently available to SpinaFX’s management team. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections, and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. We caution any person reviewing this news release not to place undue reliance on these forward-looking statements as a number of important factors could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates assumptions and intentions expressed in such forward-looking statements. Neither SpinaFX nor its representatives undertake to update any forward-looking statement, whether written or oral, that may be made from time to time by SpinaFX or its representatives or on behalf of either of them, except as may be required by law.
SOURCE Spinafx medical inc |
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