CTL Medical Achieves ISO 13485, CE Certification

CTL Medical Corporation, a Dallas, Texas-based medical device manufacturing and service company, has been granted both ISO 13485 and CE Mark certifications.
 
The International Organization for Standardization, based in Geneva, Switzerland, is an independent, non-governmental organization covering industry standards in a wide range of industries from technology to food safety, agriculture and healthcare. The ISO 13485 Certification covers medical devices and states that CTL Medical’s line of spine device implants meets the internationally agreed upon requirements for a quality management system specific to the medical device industry. The certification demonstrates compliance with regulatory and legal requirements consistent with safe and effective medical devices.
 
The CE Mark certification identifies products as being in compliance with all safety requirements established by the European Union (EU). It is required to do business within the European Economic Area, which means CTL Medical Corporation’s full line of spine device implants are now marketable in the EU Trade Zone. Specifically, The CE Marking will enable CTL Medical 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.
 
“Achieving our ISO 13485 and CE Mark certifications is a tremendous milestone for our company,” said Danny Chon, president of CTL Medical Corporation. “The certifications offer CTL Medical the validation required to replicate our record-breaking sales effort overseas within the EU, and we’re extremely excited about our future revenue projections.”
 
CTL designs, develops and manufactures spinal implants and instruments tailored to fit the unique needs of surgeons and patients. Currently, the company has nine products: Degas Anterior Cervical Plate, Van Gogh Anterior Cervical Plate, Matisse ACIF Cage, Renoir Posterior Cervico-Thoracic Fixation, Picasso-II, MIS Spinal System, Raphael Pedicle Screw System, Cezanne TLIF Peek Cage (Curved), Cezanne-II TLIF Peek Cage (Bullet Tip) and Cezanne Disc Prep Set TLIF Disc Prep Instruments.