Risk Management for Medical Devices and ISO 14971 (Online)


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The course focuses on risk analysis, evaluation and risk control. The course is practical and is suitable for anyone working with risk management such as R&D Engineers, product specialists and the Quality Assurance department.

The course covers all parts of the risk Management process including Annex Z from the EN ISO 14971:2012 version of the standard as well as an orientation on the ISO 14971 risk management’s relation to tools and techniques such as FMEA, P-MEA and FTA.


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