Software as a Medical Device (SaMD)
Result Capture
- CVML
- Bluetooth BTLE
- NFC
- ESG
- Table Top
- Point of Care
- Lab Instrument
- Lab Information System
- Self Reporting
CVML
Model Versioning
Dependency Management
Process
- Data gathering and analysis
- Collect instructions and specifications
- Datasets Creation
- Models Training
- Models evaluation
- Decision module configuration
- Deploying and testing
- Verification and validation
- Reporting
- Monitoring setup and initialization
Data gathering and analysis
Collect instructions and specifications
Datasets Creation
Models Training
- How we handle Model Bias
Models evaluation
Decision module configuration
Deploying and testing
- Frozen Models
- Static models as opposed to auto-updating models
Verification and validation
Reporting
Monitoring
Preventing Model Drift
- Input data change
- Test change
- Cameras change
https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd