Internalization of ISO 20417 - Health Products - Information to be provided by the manufacturer 2


There is still time to participate

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 the identification and labeling on a healthcare product or accessory, the packaging, marking of a healthcare product or accessory, and accompanying information. The purpose of this document is to serve as a central source for these common and generally applicable requirements, allowing each specific product standard or group standard to focus more concisely on the unique requirements for a specific healthcare device or healthcare device group.

work schedule

- Meeting for presentation of documents - Remote - 06/09/2021 - 2:00 pm to 4:30 pm

The purpose of the meeting is to introduce members to the Livelink environment, the working documents, including the text review methodology. In addition, the division of the text already translated will be defined, which each member will be responsible for reviewing. Finally, the deadlines for carrying out the work will be discussed.

- Analysis of the document by the WG members - until 09/16/2021

The part of the translated text attributed to each member must be evaluated and the notes must be made using the “Review” function of Word. The revised text with the notes must be returned by the defined date.

- Compilation and distribution of the text by the rapporteurship - until 09/23/2021

Revisions will be compiled by the rapporteur in a document, made available to members with highlights for discussion at the consolidation meeting

- Meeting for discussion and consolidation of the final text - Remote - 09/30/2020 -10:00 a.m. to 12:30 p.m.

There is still time for you to participate in this work, just send an email to sesbo@sesbo.com.br indicating your interest and a WhatApp contact until 12:00 on 06/09/2021.


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