Management Review for Medical Devices

General

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 13485:2016: 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