Package
ambientsamd
Class (IEC 62304)
TBD
Regulatory status
Pre-submission — QMS not yet stood up
Standards
IEC 62304ISO 14971FDA Premarket Cybersecurity Guidance (2023)
github ↗

SaMD · SRS

Software Requirements

7Total
6Verified
1Approved
0Draft / Review
IDTitleVerificationRisk ControlStatus
SRS-001detect_fall shall reject non-finite feature valuesUnit testRC-004Verified
SRS-002Every FallEvent shall embed algorithm_version and model_versionUnit testRC-003Verified
SRS-003FallEvent shall be immutable after constructionUnit test—Verified
SRS-004FallEvent.timestamp shall be timezone-awareUnit test—Verified
SRS-005detect_fall shall produce no file or network I/OInspectionRC-001Approved
SRS-006Fall confidence shall be a float in [0.0, 1.0]Unit test—Verified
SRS-007FallEvent.input_hash shall be a stable SHA-256 digestUnit test—Verified

Click a row to expand description and rationale.