Safety and confidence in your medical device

SESBO

Consultancy

Remember to update the references of the Anvisa RDCs that came into effect this October. Fortunately, there was no change in content, there was only an alignment to consolidate other norms on specific matters. New Affects Effective in IN 101/2021 Revokes IN 6/2011 and IN 13/2016 […]

New Anvisa RDCs for medical devices come into effect...

20/10/2021 in ANVISA / Without category by Sara

A group of experts from the IEC/SC62A + ISO/215/JWG7 committees were appointed by to determine the causes of failure of the three projects of the 2nd edition of IEC 62304 and to define recommendations for the new version of the standard, with the aim of helping the committees nationals to draw up a more assertive version […]

Failure analysis of the 2nd editions of IEC 62304

10/09/2021 in ISO/IEC / Without category by Sara

After the third CDV/DIS the project was rejected in April. It passed ISO and failed IEC and CENELEC. Despite the project being within the deadline proposed at the IEC/SC 62A plenary meeting, it was decided that: 1) SC 62A will propose to cancel IEC 62304 2nd edition of its […]

What will be the fate of IEC 62304 – Medical device...

08/09/2021 in ISO/IEC / Without category by Sara

Contribute to the fate of the 2nd edition of IEC 62304 - Medical device software. Software life-cycle processes participating in the elaboration of the international vote. Today we have published the first edition of 2006 IEC 62304 + 2015 amendment known in the regulatory field as the software standard. It's a norm […]

Preparation of the vote on the fate of the 2nd Edition of the ...

08/09/2021 in ISO/IEC / Without category by Sara

Tomorrow (09/06/2021) the work of internalizing ISO 20417 will begin, I am the rapporteur of the GT ISO 20417 working group of the ABNT CE26:150.01 Study Commission - Quality Management and Corresponding General Aspects of Medical Devices. ISO 20417 provides the requirements for identification and labeling in […]

Internalization of ISO 20417 – Health Products — Information ...

05/09/2021 in ISO/IEC / Without category by Sara

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...

13/04/2021 in ISO/IEC / SESBO tagged Software development / Medical device / medical engineering / IEC / IEC 62304 / Program / software by Sara

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...

03/03/2021 in ISO/IEC / Without category tagged software life cycle / engineering / medical engineering / Medical equipment / Software Lifecycle Process / Program / software by Sara

The Brazilian Association of Technical Standards or ABNT is a private, non-profit organization that takes care of different standards in the country. In other words, it studies and proposes ways to systematize processes, whether academic, technological, industrial, service production, among others. ABNT was created on the 28th of […]

What is ABNT?

02/02/2021 in Normalization tagged ABNT / Brazilian Association of Technical Standards / Technical Standards / What is ABNT by Sara

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 Sara

=>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

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 Sara