Tags
- 14 Agile
- 2 AI
- 2 AI-ML
- 28 CE Mark
- 24 Classification
- 7 critical software
- 19 Cybersecurity
- 40 development process
- 49 FDA
- 1 GDPR
- 3 GHTF
- 40 Guidance
- 4 IEC 60601-1
- 2 IEC 61010-1
- 57 IEC 62304
- 10 IEC 62366
- 6 IEC 81001-5-1
- 1 IEC 81001-5-2
- 6 IEC 82304
- 7 IMDRF
- 16 ISO 13485
- 18 ISO 14971
- 2 IVDR
- 6 MDR
- 8 mHealth
- 13 mobile medical app
- 5 PACS
- 3 Recall
- 39 risk management
- 12 SaMD
- 11 software failure
- 3 software item
- 3 software unit
- 19 Software Validation
- 13 Software Verification
- 12 SOUP
- 25 Template
