Focal Healthcare is pleased to announce that we have received ISO 13485:2003 certification. This certificate verifies that our quality management system conforms to the requirements of this internationally recognized standard for the design, development, production, installation, and service of medical device products. This accomplishment marks a significant milestone for our company that recognizes our dedication to providing high quality products and services that meet the needs of our customers and conform to medical device industry regulatory requirements. “The achievement of ISO 13485 certification demonstrates Focal Healthcare’s commitment to providing customers and patients with confidence that our products are designed and developed to be safe, effective, and of the highest quality standard.” – Chicuong La, President and CEO.
The ISO 13485:2003 certification was awarded on March 16, 2016, following a rigorous audit by independent, accredited certification body TÜV SÜD America Inc. ISO (the International Organization for Standardization) is the largest developer of internal standards, the use of which facilitate the creation of products and services that are safe, reliable and of good quality. ISO 13485:2003 specifies the requirements of a quality management system for medical devices, for regulatory purposes. An organization must demonstrate its ability to provide medical devices and associated services that consistently meet customer requirements, as well as the applicable regulatory requirements for medical devices and related services.