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Mandatory Problem Reporting and Recalls

J

JFriesen

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#1
Back into the QA world after a bit of a break and my brain is a bit fuzzy with the requirements regarding mandatory problem reporting and recalls for class 1 medical devices for Health Canada.
Are recalls an input into the mandatory problem reporting? We have them as two separate procedures, which is good, but I want to make sure that they link together in the proper way.
Thanks in advance!
 
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