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ISO13485 clause 7.6 Control of Non-conforming Product

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Lidong Wang Created:   Dec 02, 2020 Last commented:   Dec 04, 2020

ISO13485 clause 7.6 Control of Non-conforming Product

Our company is preparing Clause 7.6 for ISO 13485 documents. Can I have some advice on our national regulations for vigilance system which covers how the matter of adverse events should be handled.

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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 04, 2020

All necessary information about the vigilance system in Canada you can find on the following links:

The form that needs to be fulfilled in the case of adverse events you can find the link below. There is also a description of all the steps for reporting an adverse event to the authority:

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Dec 02, 2020

Dec 04, 2020

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