ISO 9001 for FIT AG

To prove the quality of its products and processes, FIT AG is certified according to DIN ISO 9001.

With ISO 9001, we guarantee standardized and documented processes that are subject to regular and systematic internal quality control.

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EN ISO 13485 for FIT AG

FIT AG is certified according to EN ISO 13485 for the production and dispatch of titanium blanks by electron beam melting (EBM) and ocular prostheses using PolyJet technology on behalf of medical device providers.

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FDA registration for FIT Production GmbH

FIT Production GmbH has been registered by the U.S. Food and Drug Administration (FDA) as a contract manufacturer of patient-specific talus implant blanks made of titanium using electron beam melting for the US market.

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TISAX for FIT AG, FIT Production GmbH, and FIT.technology GmbH

FIT AG, FIT Production GmbH, and FIT.technology GmbH have taken extensive measures to protect sensitive and/or confidential information and have oriented themselves to the questionnaire on information security of the Association of the German Automotive Industry (VDA ISA). The implementation of these TISAX requirements (Trusted Information Security Assessment Exchange) was confirmed by an external auditor. The result is available on the ENX Association portal: https://portal.enx.com/en-US/TISAX/tisaxassessmentresults/

Please contact us if you wish to have more information about the certificates.

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