Management Review for Medical Devices

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This Standard Operating Procedure (SOP) defines and describes the Management Review process, to monitor and verify the implementation of the Management System.

This assures the sustainability, suitability and effectiveness of the whole Quality Management System for medical devices and its compliance to satisfy ISO 13485 and 21CFR 820.

Management Review for Medical Devices



This SOP applies to all medical devices under development after concept and feasibility studies are completed and the COMPANY Management approves the initiation of a Product Development. This SOP applies to all personnel involved in the Management Review as well as for marketed Medical Devices.



Regulatory basis, reference documents´╗┐


  • 21 CFR Part 820, Subpart B - Quality System Regulation, 820.20 Management Responsibility
  • ISO 13485:2003: Medical Devices - Quality management systems Requirements for regulatory purposes; 5.6 Management Review
  • ISO 9001, Section 6: Resource Management



Table of Content (just Headers):


1          Purpose

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1       Company Management

4.2       Quality Head and Department

4.3       Management Committee Members

4.4       Function / Area Leaders / Project Manager

5          Related documents

6          Definitions

7          Procedure

7.1       Frequency of Management Reviews

7.2       Management Review Inputs (Agenda)

7.3       Management Review Participants

7.4       Management Review Outputs

7.5       Management Review Report and Follow up

8          Attachments

Attachment 1: Management Review Flow chart (1 page)

9          SOP distribution

10        Health, safety and environmental considerations



Size and Format:


    Microsoft Office 2003

    Word File

    15 pages procedure

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