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.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
All necessary information about the vigilance system in Canada you can find on the following links:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/canada-vigilance-program.html
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/consumer-side-effect-reporting-form.html
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 04, 2020