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Who is CriTech?

Corporate Profile

Why use CriTech?

Certification and Compliance

Certification and Compliance

Verification and Validation

Software Development

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Certification

CriTech has been certified in compliance with ISO 9001 since 1995. We are inspected every six months to ensure long- term compliance with these standards.

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

Compliance with Regulations & Standards

At CriTech, we follow a strict IEEE compliant Critical Software Development Process (CSP), which eases FDA 510(K) and PMA submissions as well as subsequent audits.

Applications that we have developed have been CE Marked for marketing in the European Community. Our Quality System is fully compliant with EN 46001, as well as various applicable standards, including EN 60601-1-4, Safety Standard for Programmable Medical Devices, and 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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Last modified: August2009