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Agile software development for medical devices

Datum & Uhrzeit

Dauer3 Stunden


NameMS Teams
StadtOffenbach am Main, Deutschland


NameFrau Helena DäschVDE Verband der Elektrotechnik Elektronik Informationstechnik e.V.

In today's constantly evolving healthcare industry, the development of medical devices, including medical software, requires a dynamic and flexible approach. One such approach is agile.

Agile is a software development methodology that emphasizes collaboration, iterative development, and quick response to change.

It has proven to be an effective way to develop medical devices that are safe, effective, and meet regulatory standards. This approach is especially useful in the development of complex medical devices that require frequent updates and modifications to meet changing market needs.

Agile enables developers to quickly prototype and test medical devices, identify potential issues early on, and refine them in a collaborative and iterative manner. This approach also allows for better quality control and faster time-to-market.

But is this approach compliant to regulatory requirements as stated by the US FDA and the legislation EU MDR?

In our online event, we discuss which relevant requirements for medical software can be implemented in an agile development environment and in what way, and how development teams can implement them.

We will have a focus on standard IEC 62304AM1 and learn how the US standard AAMI TIR 45 guides us on the use of agile practices in the development of medical device software.

Target audience:

Employees of medical technology companies, involved in the development of medical device.