case study: successful implementation and certification of iso 13485 development of a medical mobile...
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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
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Agile
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What software developers think aboutISO 13485 and IEC 62304
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The culture war
vs.
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ListenApp
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• 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
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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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