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Product complaints

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Guest user Created:   Nov 25, 2019 Last commented:   Nov 26, 2019

Product complaints

Is there a deadline for handling product complaints?

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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.

Expert
Kristina Zvonar Brkić Nov 26, 2019

There is no prescribed deadline for handling product complaints in ISO 13485:2016, in requirement 8.2.2. Complaint handling. It is the manufacturer who must define the time within which the complaint must be resolved in accordance with applicable regulatory requirements. 

For more information on complying with ISO 13485:2016 requirements, please read the article:

How to comply with ISO 13485:2016 requirements for handling complaints  https://advisera.com/13485academy/blog/2017/03/21/how-to-comply-with-iso-134852016-requirements-for-handling-complaints/

For more information managing recalls and advisory notices for medical devices according to ISO 13485, please read the following article:
How to manage recalls and advisory notices for medical devices according to ISO 13485  https://advisera.com/13485academy/blog/2017/08/31/how-to-manage-recalls-and-advisory-notices-for-medical-devices-according-to-iso-13485/

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Nov 25, 2019

Nov 26, 2019

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