Rochester, NY (USA). (August 4, 2016) – Acuity Polymers, Inc., a new entrant in the field of contact lens polymer development, has been granted ISO 9001:2008 and ISO 13485:2003 certifications for its design and manufacture of materials (polymers) used in medical devices (i.e. contact lenses).
ISO 9001 is the internationally recognized Quality Management System (QMS) standard, and ISO 13485:2003 is the established quality standard for manufacturers of finished medical devices and/or critical components within a medical device platform. The International Organization for Standardization (ISO) is the world's largest developer and publisher of international standards for the implementation of quality management systems and various other technical and operational procedures.
"Being recognized for our rigorous approach to developing and manufacturing contact lens materials gives Acuity Polymers’ customers further reason to trust in our science," states Jim Bonafini, President of Acuity Polymers. "Acuity Polymers’ certification to this standard demonstrates to the international contact lens community that our products are manufactured with the highest level of traceability and quality control."