Executives of Aurora Spine, LLC, a Carlsbad, California company that specializes in minimally-invasive regenerative technologies, announce that the firm is now ISO certified by the British Standards Institute. The firm also complies with the European Union medical device directives for CE marking. “This certification represents a major achievement and milestone for Aurora Spine. The successful completion assists us in moving forward with regulatory registrations, ” said CEO Trent Northcutt.
Aurora Spine Earns ISO Certification
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Gaining an ISO 13485 certification will enable Aurora Spine to conduct business internationally in the highly regulated sectors of the European Union, Canada, and other countries. “Whether the company is expanding locally within the United States to accommodate new business ventures or operating internationally, ISO 13485 certification will not only make Aurora Spine stand out in the medical device industry, but will demonstrate to its customers that it is fully committed to quality.” said Mike Thompson, Aurora’s director of regulatory affairs and quality assurance.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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