Medical Device Design Verification SOP

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Medical Device Design Verification SOP

Quick Overview

 This Standard Operating Procedure (SOP) describes the procedures verifying a Product’s design through appropriate inspection, testing, analysis, and review. This Verification ensures the Product Requirements, which are defined during the Design Input phase of Design Control, have been met.

Medical Device Design Verification SOP

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This SOP applies to all medical devices that are approved for Product Development as well as to the personnel who are responsible for implementing Design Controls for such medical devices. This Design Controls SOP does not apply to medical devices in very early stage of development such as early concept or feasibility stages. Design Controls begin after concept and feasibility studies are completed after the Company Management approves the initiation of a Product Development Project.

This SOP applies to the Product’s labeling including the User Manual. It does not describe the Verification process for Product software.


Regulatory basis, reference documents

  • 21 CFR Part 820 - Quality System Regulation, Subpart C - Design Controls, 820.30 Design controls
  • ISO 13485:2003: Medical Devices - Quality management systems ¬Requirements for regulatory purposes
  • FDA/CDRH - Design Control Guidance for Medical Device Manufacturers, March 11, 1997


Table of Content: 

1          Purpose

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1      Company Management

4.2      Design Review Committee

4.3      Quality Assurance

4.4      Project Leader (PL) / Head of Engineering (HE)

4.5      Function / Area Leaders

5          Related documents

6          Definitions

7          Procedure

7.1      Design Verification (general)      

7.2      Design Verification Deliverable

7.3      Design Output        

7.4      Design Verification Matrix (detail)

7.5      Design Verification Equipment Log

7.6      Design Verification Protocol

7.7      Design Verification Report

7.8      Acceptance of deviations and unresolved Non-conformances

7.9      Approval and Design Review     

8          Attachment

            Attachment 1:            Design Verification Detail Matrix (1Page)

            Attachment 2:            DESIGN VERIFICATION EQUIPMENT LOG (1 Page)

            Attachment 3:             DESIGN VERIFICATION REPORT (3 Pages)

9          SOP distribution

10       Health, safety and environmental considerations


Size and Format:

  • Microsoft Office 2003
  • Word File
  • 18 pages procedure


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