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