Gap Analysis Tool – QSR 21 CFR 820 vs ISO 13485 2016 (v1.0)

$200.00

SKU: AA005 Category: Tags: , ,

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

Reviews

There are no reviews yet.

Be the first to review “Gap Analysis Tool – QSR 21 CFR 820 vs ISO 13485 2016 (v1.0)”

Your email address will not be published. Required fields are marked *