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Certification

CriTech has been registered to ISO 9001 since 1995, and is audited twice per year to ensure long-term compliance with the standard. We were one of the first North American software companies certified to ISO 9001.

We were one of the first software companies certified to ISO 9001 under the 9000-3 Guidelines for Software Development.

Compliance with Regulations & Standards

Our IEEE and ISO 12207-based Critical Software Development Process (CSP) facilitates FDA 510(K) and PMA submissions as well as subsequent audits.

Applications that we have developed have received the CE Mark for marketing in the European Community. Our Quality System meets the software-related requirements of ISO 13485:2003, and satisfies IEC 62304, Medical device software -- software life cycle processes. Our clients are able to claim compliance with these standards as part of their CE Marking efforts.

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