Our certifications

Vitreq

Vitreq is an innovative company specialized in producing high quality instruments for the international ophthalmic industry. We offer a wide range of state-of-the-art solutions for the vitreoretinal surgeon. With many years experience in design, production and marketing of high quality products, Vitreq develops reliable and safe, next generation solutions that enhance performance and support advanced surgical techniques.

Quality is an integral part of the mission and Vitreq strives without reserve for unsurpassed product quality, reliability and patient safety through effective and compliant processes.

Certificates

ISO-certification

​Vitreq’s quality system complies with the international quality and regulatory requirements and is certified according to international standard ISO 13485:2003 medical devices – quality management systems - requirements for regulatory purposes.

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Vitreq’s quality system is also assessed by the notified body DQS Medizinprodukte GmbH and is certified according to international standard ISO 13485:2003 medical devices – quality management systems - requirements for regulatory purposes.

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CE-certification

The vitreoretinal surgical devices are certified according to the medical devices directive 93/42/EEC, annex II.

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The disposable surgical devices not used inside the eye are certified according to the medical devices directive 93/42/EEC, annex V. The intervention of the notified body is limited to only the aspects of manufacture concerned with securing and maintaining sterile conditions.

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The surgical liquid devices, laser probes and light fibers, dye and PFC squeezers are certified according to the medical devices directive 93/42/EEC, annex II.

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FDA

Vitreq B.V. is a FDA registered manufacturer of medical devices.