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PHA risk evaluation

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Guest user Created:   Mar 24, 2022 Last commented:   Mar 25, 2022

PHA risk evaluation

1. In the document ISO 13485 & MDR Integrated Documentation Toolkit – does MDR 2017/745 correspond to all 2017/746 requirements? 2. I need to create a PHA risk evaluation analysis for my medical device (photometer). I do not think that in this toolkit there is a template for PHA risk evaluation for an electrical device. Is it possible to request this document from you or to buy it separately?
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Mar 25, 2022
1. In the document ISO 13485 & MDR Integrated Documentation Toolkit – does MDR 2017/745 correspond to all 2017/746 requirements?
Our toolkit corresponds to most of the MDR requirements for the Quality Management system. We are doing right now on some more documents to be completely in compliance with Article 10 and you will be informed about it as soon as it is published.

2. I need to create a PHA risk evaluation analysis for my medical device (photometer). I do not think that in this toolkit there is a template for PHA risk evaluation for an electrical device. Is it possible to request this document from you or to buy it separately?
No, we do not have a template for the PHA. We considered that our risk traceability matrix is best that describe the requirements from the ISO 14971:2019.
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