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What this ist about
The digitalization of healthcare is progressing. Mobile applications on the smartphone or tablet PC facilitate the management of illnesses, support processes and even reach older and chronically ill patients, in addition to a young, predominantly healthy target group.
This white paper sums up current thinking on the subject and looks initially at the legal framework on the basis of the German Medical Products Act and the EU Medical Devices Directive (MDD). Using actual examples, we discuss the issue "A Medical Product — or Not?" and explain what risk analysis is, which steps a software program goes through over its lifecycle and which standards apply. Finally, we use best-practice examples to introduce those aspects to be borne in mind when planning and implementing software projects.