ABSTRACT
Medi SPICE assessment may be used to indicate the state
of a medical device suppliers software practices in relation
to the regulatory requirements of the industry, and identify
areas for process improvement. The results of these assess-
ments may also be used as a criterion for supplier selection.
The authors believe that, with the publication of the
Medi SPICE Process Reference and Process Assessment
Models, more specific guidance will be available for
the basis of process design and assessment in the
medical device industry. We describe the development of
Medi SPICE based upon applicable processes from the
ISO/IEC 15504-5[1] model. The ISO/IEC 15504-5 model
is used as a foundation upon which to develop this model.
