We are happy to announce that Hyalex Orthopaedics has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. This certification is a regulatory requirement and international standard outlining requirements for a medical device quality management system. It brings Hyalex one step closer to the clinic and patients who may benefit from the HYALEX Cartilage System.
ISO 13485:2016 is an international standard ensuring consistent design, development, production, installation, and sale of medical devices that are safe for their intended purposes. In order to receive this certification, organizations must demonstrate that their medical devices and any related services are able to consistently meet customer and regulatory requirements.
“We are thrilled to have passed our DEKRA audit and receive our ISO 13485 certification” says Hyalex VP of Quality, Richard Balano. “This certification is a big milestone in our path to bringing the HYALEX Cartilage System to the clinic and helping patients around the world.”