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
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
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