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Complaint handling and vigilance reporting

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Guest user Created:   Nov 14, 2019 Last commented:   Nov 20, 2019

Complaint handling and vigilance reporting

Pl. enlighten me on the following: How and where to include the determination of vigilance reporting in the customer complaint procedure or process
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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 Nov 20, 2019

You can include determination of vigilance reporting in the Customer compaint procedure when receiving a complaint for device malfunction, deterioration in device performance, inadequate instructions, or inadequate labeling results in death, serious injury, or may lead to death or serious deterioration in state of health if it were to recur. 

For more information about ISO 13485:2016 requirements for handling complaints, please read the following 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/


If you need more information on how vigilance system has to be prepared in EU according to MDD please read the following guidelines: https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en, and look for MEDDEV 2.12-1 rev 8 - GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM.

If you need more information how vigilance system has to be prepared according to FDA please read the following guidelines https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

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Nov 14, 2019

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