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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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