  The demand of transparency of clinical research results, the need of
accelerating the process of transferring innovation in the daily medical
practice as well as assuring patient safety and product efficacy make it
necessary to extend the functionality of traditional trial registries. These
new systems should combine different functionalities to track the information
exchange, support collaborative work, manage regulatory documents and monitor
the entire clinical investigation (CIV) lifecycle. This is the approach used to
develop MEDIS, a Medical Device Information System, described in this paper
under the perspective of the business process, and the underlining
architecture. Moreover, MEDIS was designed on the basis of Health Level 7 (HL7)
v.3 standards and methodology to make it interoperable with similar registries,
but also to facilitate information exchange between different health
information systems.
