Carlsbad, CA, December 21, 2012 --(PR.com
)-- This is an exciting time at Aurora Spine as they successfully completed the ISO stage 1 & 2 audits in November, and are now ISO certified by the British Standards Institute (BSI). The ISO 13485 standard “Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes” provides the base model for a medical device company’s quality system; it also complies with the European Union medical device directives for CE marking, Health Canada CMDCAS, and other international requirements. ISO 13485 is based on the ISO 9001 quality system process approach model for customer input, feedback, and communication.
“Compliance represents a commitment on our behalf to take our company far beyond the organizational standards of our competitors and to surpass our partner’s expectations for a quality organization. This certification represents a major achievement and milestone for Aurora Spine. The successful completion assists us in moving forward with regulatory registrations,” said Trent Northcutt, the Company’s Chief Executive Officer.
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 their customers that they are fully committed to quality,” said Mike Thompson, Aurora Spine’s Director of Regulatory Affairs and Quality Assurance.
Aurora Spine specializes in minimally-invasive (MIS), regenerative technologies. Our mission is to be the leader in advanced spinal innovations which will have a positive impact on lives worldwide.