CASE STUDY: Successful implementation and certification

of ISO 13485 Development of a Medical Mobile App

with agile development methods in compliance with ISO 13485

Joachim Neumann, VISAMED IT

Agile

What software developers think aboutISO 13485 and IEC 62304

The culture war

vs.

ListenApp

• Small screen• Usage in unforeseen conditions• Battery restrictions• Internet (data exchange, not reliable, beta-testing, privacy)• Features vs. Privacy• Location• Multimedia• Sensors• Bluetooth• Hardware• Transport / distribution• dependencies (hardware and software)• Recall and Update

Medical Mobile Apps are different

Good A lot of testingBad release soon, release oftenBad V-ModelGood Analysis PhaseGood Cyber Security, encryptionGood Use the tools of the developers for QA

- Requirements in bug tracker tool- Test planning in bug tracker tool- Wiki for documentation and Technical File- CAPA in Wiki- Digital signatures- source code control system for Documents- define roles- continuous integration

How to win the culture war

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