engineering

IEC 62304 is an international harmonized standard that provides guidance to the manufacturer on the planning, development and post-market surveillance activities for medical device software to ensure that companies comply with the requirements of international regulatory agencies. Its first version was published in 2006 […]

Equipment software lifecycle process...

in ISO/IEC / Without category tagged software life cycle / engineering / medical engineering / Medical equipment / Software Lifecycle Process / Program / software by
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

in Risk management / SESBO tagged Analysis / Analysis of Failure Modes and Effects / electronics / engineering / Clinical Engineering / Medical equipment / FMEA / Microelectronics by
=>Define your risk management process =>Establish management rules and responsibilities =>Document the risk management plan =>Establish a living risk management file =>Understand and define the scope of your device and document its intended use =>Identify potential sources of harm associated with […]

ISO 14971 Risk Management for Medical Equipment - Part 2

in Risk management / SESBO tagged electronics / engineering / Equipments / Medical equipment / Risk management / Risk Management for Medical Equipment / ISO / ISO 14971 / Medical Devices / Microelectronics by