RM-001
Risk Management Plan
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 management approach establishing the framework for all SaMD risk activities.
#risk-management#planning#iso-14971
Regulatory Standards
ISO 14971:2019ISO 13485:2016
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | Engineering Lead | Initial release |