ISO 13485 & EU MDR / 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
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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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