Whitepaper "Agile Development of Software as a Medical Device"

Download this whitepaper for a comprehensive overview of how agile methods can also be applied to medical device software development.

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What it is about

Anyone who wants to develop software as a medical device and perhaps even market it as a prescription digital health application (German: Digitale Gesundheitsanwendung, for short: DiGA) will find that this is a complex project with high demands on the people involved, their qualifications, project management and regulatory compliance. At first glance, one might assume that the regulatory requirements for medical device software (MDSW) cannot be reconciled with agile methods. But it is possible!

In this whitepaper, we will give you a compact insight into how both topics can be brought together, how we have implemented Dual-Track Agile and how agile methods can also be profitably used in the development of software as a medical device.