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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. Our clients are able to claim compliance
with these standards as part of their CE Marking efforts.
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