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Gulden Ophthalmics Achieves ISO 13485:2016 Certification

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NEWS RELEASE – Gulden Ophthalmics Achieves ISO 13485:2016 Certification

Gulden Ophthalmics has achieved ISO 13485:2016 certification for “The manufacturing, service and distribution of ophthalmic instruments, ocular implants, and conformers.”


 ELKINS PARK, PA – Gulden Ophthalmics (@GuldenEye) is now ISO 13485:2016 certified.

 ISO 13485:2016 is a voluntary quality management standard specifically for medical device manufacturers. The standard is based off of the earlier ISO 9001, which is a more general framework for quality management. ISO 13485:2016 is used by medical device regulatory agencies in many countries to enforce proper quality management systems.

Gulden’s continuous achievement of maintaining ISO 13485:2016 certification marks a consistent commitment to the superior quality of their products and brand. The certification is just one more visible sign that Gulden is always striving to better the standard of care in optometry and ophthalmology. Quality products are the foundation of quality care.

For more information about our ISO 13485:2016 certification and to see a copy of the certificate, visit Gulden’s website or contact:

Gulden Ophthalmics: 225 Cadwalader Avenue, Elkins Park, PA 19027-2020

Tel 215-884-8105 Fax 215-884-0418  •  @GuldenEye on Twitter  •