CASE STUDY: Successful implementation and certification of ISO 13485 Development of a Medical Mobile...
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Transcript of CASE STUDY: Successful implementation and certification of ISO 13485 Development of a Medical Mobile...
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
more: VISAMED IT.com