Posted By
Rutvik Patel
14-Apr-2025 11:02
Found In
Egroup:
Ontario Chapter
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Hello Hasnaa, Yes, as Shirley mentioned, it is indeed possible for a Canadian importer to obtain ISO 13485 and MDSAP certification and act as the Manufacturer of Record. I've gone through this process in the past. However, implementing a Quality Management System compliant with ISO 13485:2016 requires ...
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