Safety and confidence in your medical device

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

26/01/2021 in Risk management / SESBO tagged Analysis / Analysis of Failure Modes and Effects / electronics / engineering / Clinical Engineering / Medical equipment / FMEA / Microelectronics by Sára Oliveira

=> 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

22/01/2021 in Risk management / SESBO tagged electronics / engineering / Equipments / Medical equipment / Risk management / Risk Management for Medical Equipment / ISO / ISO 14971 / Medical Devices / Microelectronics by Sára Oliveira

GR_Port — Risk and medical equipment The patient accepts the risks of the medical device that you and I designed, developed and manufactured. And that is exactly why risk management is so important for the medical device industry. Risk Management allows you to know that medical devices that […]

ISO 14971 Risk Management for Medical Equipment - Part 1

15/01/2021 in Risk management tagged #Medical equipment by Sára Oliveira