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Austin-based Medical Device Company Earns ISO Certifications, CE Mark
Company poised to sell medical instruments and implants to international markets
Austin-based Genesys Spine, which has an array of medical implants and instruments offering novel characteristics, has earned three critical industry certifications, validating its quality processes and clearing the way for sales to the European market.
Certifications earned by the company are the CE Mark, ISO 13485 and ISO 13485 for Canada. The CE Mark is a mandatory conformity mark required to sell certain products within the European Economic Area (EEA). ISO 13485 is issued by ISO, the International Standards Organization, which is an independent membership organization that has established nearly 20,000 standards for multiple industries and is used by more than 160 countries. Genesys Spine earned two ISO 13485 certifications, one of which has slightly modified standards exclusively for the Canadian market.
ISO certification promotes confidence among domestic customers
Genesys Spine VP of Compliance Dave Lamb said of the ISO certifications, “This demonstrates that our quality system has passed a rigorous audit by a respected, independent notified body. Most countries, including the US, recognize this certification as documented evidence that we have a higher standard of quality.”
CE Mark has an even tougher set of standards
While ISO 13485 certification requires adherence to a strict set of standards, it’s a preliminary step to receiving a CE Mark.
Genesys Spine Principal Josh Kaufman said, “ISO 13485 is an international standard that establishes the excellence of our quality system, but we are also very excited to receive our CE Mark, which is a requirement for marketing our products in Europe.”
The certification process: Auditors dig deep
The certification process for both ISO 13485 and CE Mark involve having a team of auditors on site at a company for several days, combing through documentation, analyzing processes, dissecting operational procedures and interviewing employees. Lamb said, “The auditors are trained to dig deep and test the robustness of our quality system. We came through our certification audits with nothing more than a few minor observations, and we were able to respond to those very quickly and satisfactorily.”
Kaufman said, “We want to be held to the highest standards around the world. These certifications quantify those standards, establish confidence in the quality of our processes, and allow us to market our products outside the US.”
Kaufman said that with the certifications now secured, the company expects to be selling its medical devices and instruments overseas before the end of 2015.
Principal, Genesys Spine Josh.Kaufmann@genesysspine.com,
1250 S. Capital of Texas Highway
Building 3, Suite 600
Austin, TX 78746
About Genesys Spine
Founded in December of 2009, Genesys Spine was started by veterans of the spinal device start-up industry. The founding partners have used their industry knowledge and input from existing surgeon relationships to introduce, into a mature spinal fusion market, an array of medical implants and instruments with novel characteristics. These devices, with their proprietary features, all remain within existing parameters for today’s current reimbursement codes.
“Our growth and success stem from our commitment to listen and respond to the needs of the medical community,” said Genesys Spine Principal Joshua Kaufmann.