CASE STUDY: Successful implementation and certification of ISO 13485 Development of a Medical Mobile App with agile development methods in compliance with ISO 13485
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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
- 1. 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
- 3. Agile
- 4. What software developers think about ISO 13485 and IEC 62304
- 7. ListenApp
- 8. • 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
- 9. Good A lot of testing Bad release soon, release often Bad V-Model Good Analysis Phase Good Cyber Security, encryption Good 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