Hospitals

AccelSPINE receives CE marking and EN ISO 13485 certificate

AccelSPINE, a Dallas-based medical device designer, recently announced it has received CE marking and European ISO 13485 certification.

AccelSPINE’s CE marking allows the company to expand its customer base to the European Union and the five additional countries that adhere to European Union regulations. The designations, awarded by TUV Rheinland LGA Products GmbH after quality assurance audits, went into effect on Nov. 18, according to a press release from AccelSPINE.

The EN ISO 13485:2012 and EN ISO 13485:2012/AC: 2012 certifications acknowledge that AccelSPINE “has established and applies a quality management system for medical devices for the following scope: Design and Development, Manufacture, Distribution of Non-sterile Spinal Implants and Instruments.”

“Obtaining a CE marking and an EN ISO 13485 at the same time is rare in our industry,” Danny Chon, president and chief executive officer of AccelSPINE, said in a press release. “Certification processes take a lot of time and require that you meet certain standards that not every company is ready for. In addition, an EN ISO 13485 certification is not required for a company like ours, but obtaining both was important to us. It is a symbol of our commitment to excellence.”

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