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Medical Device Quality Review Guide

This document provides a template for a management review meeting at a company. It lists required attendees and an agenda covering internal audit results, corrective and preventive action plans, customer feedback, quality policy, management system effectiveness, supplier management, manufacturing processes, training requirements, and resource effectiveness. The template is meant to help structure discussions at a management review meeting to ensure all important quality topics are covered.
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0% found this document useful (0 votes)
215 views1 page

Medical Device Quality Review Guide

This document provides a template for a management review meeting at a company. It lists required attendees and an agenda covering internal audit results, corrective and preventive action plans, customer feedback, quality policy, management system effectiveness, supplier management, manufacturing processes, training requirements, and resource effectiveness. The template is meant to help structure discussions at a management review meeting to ensure all important quality topics are covered.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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SAMPLE MANAGEMENT REVIEW TEMPLATE

This is an extra resource to go along with the original article:


5 Biggest Quality Mistakes (And How You Can Avoid Making Them)

MANAGEMENT REVIEW MEETING

[ Company Name ] [ Date ]

REQUIRED ATTENDEEES:

[ Name (Position) ] [ Name (Position) ]

[ Name (Position) ] [ Name (Position) ]

[ Name (Position) ] [ Name (Position) ]

AGENDA

AGENDA ITEM: LEAD BY:

Actions from previous meeting [ Name (Position) ]


Internal audit results (may split by different areas) [ Name (Position) ]
CAPA [ Name (Position) ]
Customer complaints or feedback [ Name (Position) ]
Quality policy (company performance and relevant regulatory changes) [ Name (Position) ]
Quality management system effectiveness [ Name (Position) ]
Supplier management [ Name (Position) ]
Manufacturing process [ Name (Position) ]
Company training requirements [ Name (Position) ]
Resources (effectiveness and any changes needed) [ Name (Position) ]

© 2021 Greenlight Guru | Medical Device Success Platform (MDSP)

Greenlight Guru is the only quality management software designed specifically for medical device companies to bring
safe and effective products to market faster, with less risk, and keep them there for the duration of the device lifecycle.
The cloud-based solution provides a single source of truth by connecting all quality processes
that streamline the production of True Quality medical devices.

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