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Medical Devices

ISO 13485 Medical Devices Management System

ISO 13485 MEDICAL DEVICES MANAGEMENT SYSTEMObjective To provide delegates with a thorough understanding of: • ISO 13485 Medical Devices - Quality Management System • Proven Implementation Methodology • Key Success Factors and Obstacles • Documentation required

ISO 14971 Application of Risk Management to Medical Devices

ISO 14971 APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICESObjectiveTo provide delegates with a thorough understanding of ISO 14971:2007• ISO 14971:2007 Risk Management• Intended Use and Charasteristic Product• Integrated with ISO 13485 & ISO 9001 Management system• The necessary skills