Art Optical Contact Lens, Inc. – a leading provider of custom-designed gas permeable and soft contact lenses, is pleased to announce that following an audit of their quality management systems, they have been certified to ISO 13485:2003. The Art Optical quality system was audited by BSI Management Systems America Inc., one of the foremost auditing bodies in the world.
ISO 13485 is a world-recognized medical device quality system standard that is considered an important milestone in terms of global market expansion, and is currently the most stringent standard of quality control for medical devices. Although Art Optical is already compliant with the FDA’s revised Quality System Regulation, as well as ISO 9001 quality system standards, the company actively pursued the ISO 13485:2003 certification to ensure the superiority of its quality and business management systems. By meeting ISO 13485 guidelines, Art Optical demonstrates that its medical device design and development processes meet objective quality standards.
According to Jill M. Anastor, Vice President of Operations at Art Optical, maintaining a world-class quality management system will remain a key strategic objective for Art Optical and its 80-plus employees. “The accreditation reflects our commitment to quality and is an important step in the overall development of our product strategy,” Anastor noted. “ISO 13485 certification also allows us to cultivate new distributor and licensing agreements internationally, while sustaining, and possibly expanding, our manufacturing operation here in the U.S.”
Art Optical Contact Lens, Inc. is an independently owned and operated company serving ophthalmic professionals world-wide with custom contact lenses made to exacting standards for the correction of refractive errors including myopia, hyperopia, astigmatism, and presbyopia. The company also provides customized contact lenses for pediatric patients as well as those with irregular corneal conditions resulting from post surgical or post corneal trauma situations, pathological concerns, and ocular disease. Originally founded in 1931, Art Optical is based in Grand Rapids, Michigan, and is widely recognized as a world-leader in the design, production, and application of custom contact lenses.
For additional information, contact:
Mindy Spicer, Director of Marketing & Communications
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