ISO 13485:2016 Active
v1.0
DocumentsDesign ControlsDC-008
Document Number
DC-008
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
7.3.7
Tier Level
Tier 2 — SOP/Plan

Design transfer to production ensuring the design is correctly translated into manufacturing.

#design-transfer#production#manufacturing
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
ISO 13485:201621 CFR Part 820

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release