Sára Oliveira








Hoje iremos ver como a IEC 62304 trata o processo de desenvolvimento de software desde o planejamento até o lançamento do dispositivo médico. Alguns requisitos dependem da classificação de segurança do software ( trato disto no primeiro post desta série "Processo de ciclo de vida de software de equipamento Médico […]

Software development for Medical Device as per...



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...



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