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Dear All Cove readers,
M Company just been certified to ISO 13485, however in the surveilace audit, non-conformities were found. One of it is : No evidence sighted for the inclusion of ISO 13485 requirements i.e post market vigilance & product recall etc during the recently concluded IQA exercise.
Can someone comment on this and how to show evidence in this aspect?
Thx.
M Company just been certified to ISO 13485, however in the surveilace audit, non-conformities were found. One of it is : No evidence sighted for the inclusion of ISO 13485 requirements i.e post market vigilance & product recall etc during the recently concluded IQA exercise.
Can someone comment on this and how to show evidence in this aspect?
Thx.



