Content By Grant Ramaley

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By: Grant Ramaley

Some European Commission notified bodies have been forcing a position that a medical device must conform to the latest technical standards to meet the European legal requirement for “state of the art.” As a result, some manufacturers have been pressed into paying tens of thousands of dollars to retest their products or risk losing their CE Mark.

Grant Ramaley’s picture

By: Grant Ramaley

One of the greatest challenges that I have in discussing standards is trying to put things in a context so that all people affected by them can understand how they matter. So I want to start with a simple picture and a remarkable snapshot in time. It shows how small medical-device companies are making major contributions to health care, and begins another story that explains how one standard is threatening to undo these gains.

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