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Archive | Risk management for medical devices and ISO 14971

News relating to the Gantus course: Risk management for medical devices and ISO 14971.

Risk management conference

The risk management conference participants discussed FMEA in relation to ISO 14971 and risk analysis. The conclusion was that FMEA is not risk management, nor risk analysis. Not so revolutionising, but still creates discussions. On the two-day risk management conference in Berlin, representatives from industry and notified bodies met to discuss risk management. Presentations were […]

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