Safety and confidence in your medical device

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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 Sára Oliveira

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 Sára Oliveira

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 Sára Oliveira

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 Sára Oliveira

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 Sára Oliveira

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 Sára Oliveira