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Friday, February 11th

GMED Guides

Changes to medical device and/or quality management system: when and how to submit a request?

Visuel Guide des modifications GB

The purpose of the guide, prepared by GMED, is to clarify when and how to submit a change application for a medical device and/or quality management system that is subject to certification by GMED.

In particular, this document outlines the different types of changes (substantial and significant), describes the different steps in the change assessment process, and provides concrete examples to help determine whether a proposed change should be notified to GMED.

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Changes to medical device and/or quality management system: when and how to submit a request?

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