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Showcasing the Global Regulatory Model

This article was originally published in RAJ Devices

Executive Summary

The Global Harmonization Task Force has issued a key document that explains the overall design of the global regulatory model for medical devices that the initiative has been working on since its creation 15 years ago1. The document shows for the first time how the numerous guidance documents the GHTF has issued over the years – together with other important documents – interrelate and intersect and how they relate to the medical device life cycle.

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