ISO 13485:2016 Active
v1.0
DocumentsDesign ControlsDC-003
Document Number
DC-003
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
7.3.2
Tier Level
Tier 2 — SOP/Plan

User needs and product requirements including F-001 to F-166 functional requirements and NFRs.

#requirements#srs#user-needs
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
ISO 13485:2016IEC 62304:2006+A1:2015

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release