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Existing products: how far should firms go in evaluating new risks?

This article was originally published in Clinica

Executive Summary

To what extent should manufacturers apply new standards to devices already on the market? That is the question being faced by all medical device companies, and especially those manufacturing products with the potential to cause electromagnetic interference or to be affected by it. Medical device consultant Trevor Lewis believes that changes in regulations and standards reflect changes in the Real World in which devices operate, and warns that companies must urgently face up to these, or risk potential product liability suits.

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