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IEC 62366-1 question

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Guest user Created:   Dec 09, 2021 Last commented:   Dec 13, 2021

IEC 62366-1 question

Hi Kristina – is this standard only applicable to medical devices with computer/software components? If so, is there a different usability standard that pertains to non-computer related medical devices ?
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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 Dec 13, 2021

No, this standard ISO 62366-1 is applicable for all types of medical devices. 

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Dec 09, 2021

Dec 13, 2021

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