Strategic input into diagnostics development
In-vitro diagnostics have made a career. A few years ago, they could be used to measure blood parameters like glucose or liver enzymes, however, fuelled by gene technology, they are now becoming very specific tools for the analysis of medical conditions or gene abnormalities. They are being used in the field of gene diagnostics as well as for early recognition of pre-canceroses and cancer.
Development according to the medical device legislation needs to take into account the following steps and issues:
