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Auditing according to section 8.2.2

ISO 13485 & EU MDR
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Guest user Created:   Dec 09, 2021 Last commented:   Dec 13, 2021

Auditing according to section 8.2.2

ISO 13485 & EU MDR
I've been asked to conduct a 13485 audit specific to complaint handling. Would I only need to audit according to section 8.2.2? Thank you!
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
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Kristina Zvonar Brkić Dec 13, 2021

Basically yes, but of course in accordance with Records management (requirement 4.2.5) and 8.3 Control of non-conforming product. 

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Dec 09, 2021

Dec 13, 2021

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What sections of ISO 13485 cover computer systems?

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