Monthly Archives: January 2021


The FMEA analysis aims to identify potential failure modes of a product or process in order to assess the risk associated with these failure modes so that they are classified in terms of importance and then receive corrective actions in order to reduce the incidence of failures . […]

FMEA- Analysis of Failure Modes and Effects


=> Define your risk management process => Establish the management rules and responsibilities => Document the risk management plan => Establish a live risk management file => Understand and define the scope of your device and document the intended use => Identify the potential sources of damage associated with […]

ISO 14971 Risk Management for Medical Equipment - Part 2