AccelSPINE Awarded CE Marking and EN ISO 13485

Dallas-based medical device designer and manufacturer AccelSPINE received its CE Marking and European ISO 13485 certification last week. The CE Marking will enable AccelSPINE it to expand its customer base to the 28 countries that make up the European Union and five additional countries that adhere to European Union regulations.

“Obtaining a CE Marking and an EN ISO 13485 at the same time is rare in our industry,” said Danny Chon, president and CEO of AccelSPINE. “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 isn’t required for a company like ours, but obtaining both was important to us. It’s a symbol of our commitment to excellence.”

The designations, effective Nov. 18, were awarded to AccelSPINE by TUV Rheinland LGA Products GmbH after extensive quality assurance audits. AccelSPINE’s ISO designations are EN ISO 13485:2012 and EN ISO 13485:2012/AC: 2012, acknowledging 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.”

AccelSPINE’s CE Marking or EC Certificate signifies a full quality assurance system for its medical devices pursuant to Directive 93/42/EEC Annex II (excluding section 4). To obtain a CE Marking, products must adhere to the requirements of relevant European legislations and standards. Products that obtain a CE Marking can be sold to the European Union member countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom. In addition, the CE Marking grants AccelSPINE access to other countries who abide by European Union regulation, such as Turkey, Iceland, Liechtenstein, Switzerland and Norway.

AccelSPINE is a nationally recognized medical device company headquartered in Dallas, Texas. The company designs, develops, manufactures and distributes spinal implants and instruments that are tailored to fit the unique needs of surgeons and patients.