Nov. 15, 2019
San Diego, Calif. – C&E GP Specialists Inc., a leading manufacturer of orthokeratology specialty rigid gas-permeable contact lenses, has been awarded the ISO 13485:2016 management system certificate.
The ISO 13485:2016 certificate is provided exclusively to organizations that manufacture and sell medical devices while meeting the standards for a management system that provides consistent customer and applicable regulatory requirements.
“We are proud to have met the high standards required by ISO 13485:2016. While GP Specialists has been ISO certified for many years, the new ISO 13485:2016 certification provides GP Specialists recognition in achieving the new standards of quality medical device manufacturing. Additionally, our new certificate is NS-EN™ ISO 13485:2016, which is the Norwegian Standard that encompasses Europe and other international locations,” said Steve Wagner, president of C&E GP Specialists.
“The ISO 13485 was created to reduce regional regulatory requirements and to harmonize the international medical device manufacturing industry. Meeting the new ISO requirements required significant effort on our part,” said Mark Cosgrove, vice president of C&E GP Specialists. “It is likely many small custom GP labs will not be able to meet the high level of compliance required by the new ISO standards. An ISO certificate is required to sell internationally to our Asian business partners. It is expected that the new ISO 13485:2016 will become an integral part of our FDA compliance exams.”
About C&E GP Specialists C&E GP Specialists, Inc. is committed to “Reshaping the Way the World Sees™”. GP Specialists is best known its expertise in manufacturing orthokeratology lenses and consulting on numerous ortho-k designs. GP Specialists represents Paragon Vision Sciences CRT™ contact lenses, while manufacturing the orthokeratology designs of Dr. Tung’s Global OK-GOV™, Dr. Chow’s Ortho Tool™ and its own ortho-k contact lens designs Fargo™, iSee™ and iSee2™. GP Specialists ortho-k lenses are found worldwide including China, Vietnam, Korea, Taiwan, Malaysia and Australia. GP Specialists additionally manufacturers the iSight™ and CXL™ Scleral contact lenses for post corneal crosslinking, keratoconus and other irregular corneas.