Document Number
SW-002
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
IEC 62304 5.2
Tier Level
Tier 2 — SOP/Plan
Full SRS covering F-001 to F-166 functional requirements plus non-functional requirements.
#srs#requirements#functional#nfr
Approval Status
DraftEffective: May 7, 2026
Regulatory Standards
IEC 62304:2006+A1:2015ISO 13485:2016
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | Engineering Lead | Initial release |