Guest user Created: Feb 27, 2020 Last commented: Feb 28, 2020

State of validation

State of validation of your templates, especially related to the new 14971:2019. Were already confirmed by notifying body, if yes - which one? I wonder if your consultants can cover risk discussion from a particular device, related to the particular risks affected by this new standard.

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Kristina Zvonar Brkić Feb 28, 2020

We just yesterday have published new version of our Toolkit for ISO 13485:2016 where documentation for risk assesment is in accordance with the new ISO 14971:2019.

On this link you can see the preview of documents in our toolkit ISO 13485 & MDR Integrated Documentation Toolkit. In this toolkit, risk assesment is prepared according to the ISO 14971:2019. You can check by yourself how does documents from risk assesment are adaot to ISO 14971:2019: https://advisera.com/13485academy/iso-13485-eu-mdr-documentation-toolkit/

List of notified bodies that are that are in compliance with Medica device regulation (MDR 2017/745) are on the following link: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

You can send us questions for anything you do not understand and we will answer. Also you can schedule a phone call with our expert.

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Feb 27, 2020

Feb 28, 2020

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