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MDR/ISO 13485 risk management of "SYSTEM"

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Guest Created:   Nov 22, 2022 Last commented:   Nov 22, 2022

MDR/ISO 13485 risk management of "SYSTEM"

Our company manufactures system (of products) as defined by MDR 745/2017 definition ( "system’ means a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose"). I would like to know if the risk analysis, clinical evaluation and post market surveillance is done for the whole system or its individual parts. Thank you.
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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 Nov 22, 2022

It should be done for its individual parts. 

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Nov 22, 2022

Nov 22, 2022