Software: all-important, but all too easily overlooked
This article was originally published in Clinica
Executive Summary
Badly-written or inadequately-tested software can lead to adverse incidents with medtech products. Yet lack of attention to this issue results in regulators and manufacturers often citing software as a source of problems in real use. In this article, medtech consultant Trevor Lewis gives some much-needed pointers about how to start working towards the "state of the art" demanded by the EU Medical Devices Directive (93/42) and its revised version (2007/47) - which must be fully applied by March 21 2010