Risk Management for Medical Devices and ISO 14971

1,340.00

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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