Quality Management

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Recognized as the world leader in corneal cross linking, quality lies at the heart of IROC.

All development, manufacturing and assembling processes of the IROC R&D department for both, internal and external projects, fulfill highest standards for medical device manufacturing.

IROC is certified according to EN ISO 9001:2000.

February 2008: IROC AG is pleased to announce that as of February 1^st 2008 the research, development and technology division is certified by the international quality management norm for medical device manufacturers DIN EN ISO 13485:2003.

Additionally, the lay out design, assembly and final inspection of IROC’s illumination system UV-X^TM for the treatment of keratoconus, have been successfully certified according to directive 93/42/EEC, Annex II by LGA InterCert GmbH – notified body No. 1275.

We have taken this logical step of upgrading our already existing quality management system according to norm ISO 9001:2000 to meet the highest demands of modern eye care. In doing so, we guarantee a continued effort towards top-quality research, workmanship and service.

If you have further questions or would like a copy of the certificate, please do not hesitate to contact us.

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