Description
This document is a gap analysis tool (Excel) to compare the clauses of the Quality System Regulation of the U.S. (21 CFR § 820) and the clauses of the ISO 13485:2016.
3 tabs:
- Tab1: Gap Analysis FDA 21 CFR Part § 820 vs ISO 13485:2016 (103 lines)
- Tab 2: Relationship of FDA 21 CFR Part § 820 with ISO 13485:2016 (100 lines)
- Tab 3: General Information: FDA 21 CFR Part § 820 and the ISO 13485:2016 (28 lines)
Template version: 1.0
Sample:
Tab 1
Tab 2
