RM-004
Risk Control
Version
v1.0
Effective Date
May 7, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 2 — SOP/Plan
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
ISO 14971:2019
Category
Risk Management
Risk control measures including ALARP justification and residual risk evaluation.
#risk-control#alarp#mitigation
Regulatory Standards
ISO 14971:2019ISO 13485:2016
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | Engineering Lead | Initial release |