CTL Medical Corporation, a Dallas-based medical device manufacturing and service company, announced that it has applied for and 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 health care. 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. 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,” stated 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.”