ISO-13485 and CE Mark

In 2017 Cerahi Industries was awarded ISO-13485 certification, internationally recognized standard that ensures instruments meet the demands and needs of of practitioners through an effective quality management system.

To be ISO-13485 compliant, Cerahi was evaluated on quality management system development, documentation review of management system, initial assessment, pre-audit, and clearance of non-conformance.

Also, our CE mark certification assures conformity with health, safety, and environmental protection standards meeting the requirements of the applicable EC directives.

Further more Cerahi has also applied for FDA certification and approval and will soon also be approved from FDA cGMP regulations.

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