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We implemented several years ago a formal quality management system. It is
consigned in our
“Quality Management System Manual”
which describes the processes we have implemented to define, maintain and
improve quality across our products and our activities.
Confirming the reality of our quality processes, we obtained our
ISO 9001:2008
and our
ISO 13485:2003
certifications.
If
ISO 13485:2003
certification is not unusual among medical device manufacturers, it is
extremely rare among software vendors.
Our certification attests our will to remain well ahead of market practice.
Having undergone the
same certification process as yourselves, we
proclaim to know the demands and constraints of your trade.
Furthermore Normand has extensive experience in the development of software
requiring registration with the
FDA
or with the
European Community. Several of them are registered
with both the FDA and the European Community.
Click the following links to view the certificates:
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