PROGRAMME - KEYNOTES

Legal Requirements for the Verification and Validation of Healthcare Applications

Prof. Christian Johner, Director
Institut für IT im Gesundheitswesen

Today it is unthinkable to abandon software in healthcare. As the usage of medical software is spreading and the complexity of the systems is rising, the number of problems related to medical software is escalating.
As a consequence legislators, authorities and standardisation committees increase the number of standards and laws, which become more and more specific for medical software.
This presentation provides a consolidated overview of the legal requirements for validation and verification of healthcare applications. It addresses current trends and gives concrete advices how to develop medical software effectively and efficiently and (nevertheless) comply with standards and laws.