IMDRF Consultation Feedback - QMS WG - Guidance on the Control of Products and Services Obtained from Suppliers

Overview

This document is a revision of the document GHTF SG3 (Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers - December 2008) to reflect the current state of the art and experience gained from use of the initial version.

This document provides regulatory guidance for manufacturers on the control of products and services obtained from suppliers, throughout the life cycle of medical devices.

Note: This guidance applies to all medical devices, including IVD medical devices and combination products (if regulated as medical devices).

This guidance is applicable to manufacturers of medical devices, irrespective of their size, and can be used by other interested parties providing a service or product such as importers and distributors.

This online form is designed for a maximum of 10 proposed changes. Should you prefer, or have more than 10 changes, you will be provided the option to download a change form which can be submitted as an attachment once completed.

Why your views matter

The IMDRF Quality Management Systems Working Group appreciates your feedback which will be considered prior to finalization of the document for publication.