Call for experts
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 is a very important standard, as all medical devices that have software must comply.
After three failed attempts to define the second edition, the IEC asks the national committees to contribute to the fate of the second edition. This work will be developed by the GTC 03/01 - Joint Working Group on Software for Medical Devices of the ABNT/CB-026/CE commission 026 020 001 - Common Aspects for Safety of Electromedical Equipment.
Learn more about the history of this standard on the Post What will be the fate of IEC 62304?
The deadline for concluding the vote by CE 026 020 01 is 10/01/2021.
In the role of GTC 03/01 rapporteur, I am publicizing this demand and inviting manufacturers, experts in the development of standards, competent authorities, and conformity assessment bodies interested in participating in the working group that will prepare the vote with the position of Brazil on the future of IEC 62304.
The works will be developed during the month of September. The forecast for presentation to the study committee 026.020.001 for deliberation will be at the meeting on October 1, 2021.
The work dynamic will follow the following methodology and deadlines:
- Constitution of the Working Group - until 13/09/2021.
Interested parties with availability for contribution should send an email to the reporter (sesbo@sesbo.com.br) with contacts for inclusion in the WG (name, email, company and WhatApp contact). Before applying, read the email to the end, paying attention to remote meeting dates and delivery dates.
- Meeting for presentation of documents - Remote - 13/09/2021 - 1:30 pm to 3:00 pm.
The purpose of the meeting is to introduce members to the Livelink environment, working documents and describe the background of the standard.
- Meeting to define the vote and division of work - Remote 09/17/2021 - 15:00 to 16:30 hs.
At this meeting, the Brazilian proposal for the rule's destination will be discussed and defined, in addition to dividing the work for reviewing the text and additional comments to the vote.
- Submission of the work developed by the WG members - until 09/23/2021
The part of the vote attributed to each member must be developed and must be returned by the defined date.
- Compilation of the text by the rapporteurship - until 09/28/2021
The texts will be compiled by the rapporteur in a document, made available to members with highlights for discussion at the consolidation meeting
- Meeting to discuss and consolidate the vote - Remote - 09/30/2020 - 3:00 pm to 4:30 pm
The purpose of the meeting is to consolidate the vote for forwarding and deliberating the EC 026 020:01 at the meeting on 10/01/2021.
I await your return counting on your participation in this vote.
Sara Oliveira
GTC Rapporteur 03/01 - Joint Working Group on Medical Device Software
ABNT/CB-026/CE 026 020 001 - Common Aspects for Safety of Electromedical Equipment