Difference between the Risk management parts in the Toolkits

1. What is the difference between the Risk management parts (06) of ISO_13485_MDR_Integrated_Consultant_WL_Toolkit_Preview_EN and ISO_13485_MDR_Integrated_Documentation_Toolkit_Preview_EN?

There are no differences in the text of the document itself. The document is the same. The difference is that Consultant documents are "white-labeled" signs - do not have Advisera tags and whoever buys a consultant toolkit can use it for their clients. While "ordinary" documents/toolkits in accordance with Advisera's policy cannot be used to implement standards with the client.

2. And do I nee also the risk parts (6) of ISO_13485_Documentation_Toolkit_Preview_EN?

Yes, you do need this part. According to requirement 7.1 Planning the production, Risk management is a vital element of the ISO 13485:2016. This risk management is prepared according to the ISO 14971:2019 Medical devices - Application of risk management to medical devices - which is the only risk management standard from the list of harmonized standards: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:090I:TOC

Following article can make a better explanation:

• How to use ISO 14971 to manage risks for medical devices - https://advisera.com/13485academy/blog/2017/09/21/how-to-use-iso-14971-to-manage-risks-for-medical-devices/