Controversy & Confusion: What Does Annex Z of EN/ISO 14971: 2012 Mean & How Can We Practically Implement It?

Controversy & Confusion: What Does Annex Z of EN/ISO 14971: 2012 Mean & How Can We Practically Implement It?

Chuck Sidebottom, Director, Corporate Standards at Medtronic and Dave Osborn, Manager, International Standards at Philips, discusses the current controversy over the application of risk management under the European medical device directives, how the expectations for risk management have changed, how EN/ISO 14971 has been revised to deal with these expectations and how manufacturers and notified bodies are reacting to these revisions, which are causing a degree of confusion.


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