software

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...

in ISO/IEC / SESBO tagged Software development / Medical device / medical engineering / IEC / IEC 62304 / Program / software by
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