Committed to Quality, Blatek has achieved the coveted ISO 9001 and ISO 13485 certification in February of 2009. ISO 9001 recognizes the requirements for a good quality management system. ISO 13485 is the internationally recognized standard for quality management in the medical device industry. Blatek has deployed a Quality Management System compliant with ISO 9001 and ISO 13485 developed under the FDA GMP guidelines. Our Quality Management System has been developed and deployed by a team that is dedicated to Quality initiatives with full support from the management team. Blatek has a development team led by the Quality Manager, who has 13 years of experience in the Quality field, and also includes a certified Lead Internal Auditor for ISO 13485 by RAB/QSA. The ISO 9001 and ISO 13485 standard for quality management systems will allow us to reach new heights in production efficiency, customer service, and quality.