Saladax Biomedical has achieved ISO 13485:2003 certification for the design, manufacture and distribution of in vitro diagnostic medical devices in the area of clinical chemistry.
Saladax’s Bethlehem facility was certified after a comprehensive audit of the company’s quality systems was conducted by KEMA, an internationally recognized standards registrar.
ISO 13485:2003 is an international standard for quality management systems supporting the design and manufacture of medical devices. The standard focuses on fulfilling customer and regulatory requirements with a charter to enhance quality and customer satisfaction.
Salvatore Salamone, CEO of Saladax, said: “ISO certification recognizes that Saladax complies with the highest level of international business practices, a standard of operations and reliability that is acknowledged for providing added-value and assurance to customers. Our compliance with the ISO standard clearly reflects Saladax’s dedication to ensuring the highest quality products and business processes.”
Saladax Biomedical develops diagnostic tests for the practical delivery of personalized medicine. The company’s products span all stages of development and address a variety of therapeutic areas, with an initial focus in oncology with its Mycare portfolio.